<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03828019</url>
  </required_header>
  <id_info>
    <org_study_id>9196</org_study_id>
    <nct_id>NCT03828019</nct_id>
  </id_info>
  <brief_title>Adalimumab vs. Conventional Immunosuppression for Uveitis Trial</brief_title>
  <acronym>ADVISE</acronym>
  <official_title>Adalimumab vs. Conventional Immunosuppression for Uveitis Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JHSPH Center for Clinical Trials</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>JHSPH Center for Clinical Trials</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non-infectious intermediate, posterior, and panuveitides are chronic, potentially-blinding&#xD;
      diseases. Vision-threatening cases require long-term therapy with oral corticosteroids and&#xD;
      immunosuppression. Based upon preliminary data, adalimumab, a fully-human, anti-TNF-α&#xD;
      monoclonal antibody, now US FDA-approved for uveitis treatment, may be a superior&#xD;
      corticosteroid-sparing agent than conventional immunosuppressive drugs. The ADVISE Trial is&#xD;
      multicenter randomized, parallel-treatment, comparative effectiveness trial comparing&#xD;
      adalimumab to conventional (small molecule) immunosuppression for corticosteroid spring in&#xD;
      the treatment of non-infectious, intermediate, posterior, and panuveitides.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Abstract from protocol: The uveitides are a collection of diseases characterized by&#xD;
      intraocular inflammation. Collectively, they are the 5th leading cause of blindness in the&#xD;
      US, and the estimated cost of treating them is similar to that of treating diabetic&#xD;
      retinopathy. Non-infectious intermediate, posterior, and panuveitides have the highest rates&#xD;
      of visual loss and typically are treated with oral corticosteroids and immunosuppression. The&#xD;
      Multicenter Uveitis Steroid Treatment (MUST) Trial (a randomized, comparative effectiveness&#xD;
      trial, which compared 2 treatment paradigms for these diseases, systemic therapy with&#xD;
      corticosteroids and immunosuppression vs. regional therapy [the fluocinolone acetonide&#xD;
      implant]), and Follow-up Study demonstrated the superiority of the systemic approach to the&#xD;
      regional ocular approach in terms of long-term visual outcomes with essentially no increase&#xD;
      in systemic side effects in the systemic group. One key to systemic therapy's success was the&#xD;
      use of systemic immunosuppression in 88% of participants, coupled with tapering the&#xD;
      prednisone to &lt;7.5 mg/day, a relatively safe dose. Non-alklyating agents are typically the&#xD;
      first choice and the most often used are azathioprine, methotrexate, mycophenolate,&#xD;
      cyclosporine, and tacrolimus. The alkylating agents, cyclophosphamide and chlorambucil, are&#xD;
      used less often because of concerns about potential increased malignancy risk. Data from the&#xD;
      Systemic Immunosuppressive Therapy for Eye Diseases (SITE) Cohort Study suggest that each of&#xD;
      the conventional, non-alkylating agent immunosuppressive drugs is effective in controlling&#xD;
      the inflammation while permitting tapering prednisone in ~40-55% of patients; hence&#xD;
      combination therapy often is needed. Furthermore, minimizing the daily dose of prednisone is&#xD;
      important, as the risk of cardiovascular disease and mortality increase with the cumulative&#xD;
      dose of oral corticosteroids. In June 2016, the fully-human, anti-TNF-α monoclonal antibody,&#xD;
      adalimumab, was approved by the US Food and Drug Administration (FDA) for the treatment of&#xD;
      uveitis. Anti-TNF-α monoclonal antibody therapy has revolutionized the management of the&#xD;
      rheumatic diseases largely due to its superior efficacy compared to conventional Disease&#xD;
      Modifying Anti-Rheumatic Drugs. Data from VISUAL III, the extension of the two phase 3 trials&#xD;
      that led to the FDA approval of adalimumab for the treatment of uveitis, suggest that&#xD;
      adalimumab may be superior to conventional immunosuppression, as ~75% of participants had&#xD;
      controlled inflammation with prednisone doses &lt;5 mg/day. The ADalimumab Vs. conventional&#xD;
      ImmunoSupprEssion for uveitis (ADVISE) Trial is a randomized, comparative effectiveness trial&#xD;
      comparing adalimumab to conventional agent immunosuppression for patients with&#xD;
      non-infectious, intermediate, posterior, and panuveitides. The primary outcome is the ability&#xD;
      to successfully taper prednisone to &lt;7.5 mg/day by 6 months after randomization while&#xD;
      maintaining control of the inflammation. Secondary outcomes include prednisone&#xD;
      discontinuation by 1 year, visual acuity, and complications of uveitis and its treatment.&#xD;
&#xD;
      ADVISE is being conducted under IND 132532. Adalimumab was FDA approved for the treatment of&#xD;
      non-infectious intermediate, posterior, and panuveitides in adult patients in 2016 and in&#xD;
      pediatric patients 2 years of age and older in 2018. In 2016, prior to the approval for&#xD;
      pediatric patients, the FDA determined that use of adalimumab for the treatment of&#xD;
      non-infectious intermediate, posterior, and panuveitides in adolescent patients in the ADVISE&#xD;
      Trial does not increase risk for these patients as the drug is approved for treatment of&#xD;
      pediatric patients for other indications. Although conventional immunosuppressive drugs are&#xD;
      the standard approach and in widespread use, these drugs are not FDA approved for treatment&#xD;
      of non-infectious intermediate, posterior, and panuveitides, and therefore an IND has been&#xD;
      issued for this trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 17, 2019</start_date>
  <completion_date type="Anticipated">February 29, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized treatment assignment with allocation ratio: 1:1 and two stratification variables: (1) number of immunosuppressive drug patient is on at time of enrollment (zero vs. one); (2) Initial dose of prednisone patient will be on in trial (&lt;30 mg/day vs. ≥30 mg/day). The unit of randomization is the patient,</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Unmasked treatment administration and outcome assessments (participants, study ophthalmologists, visual function examiners, and study coordinators are all unmasked). Masked assessment of baseline, 1-month, 3-month, and 6-month photographic images and OCT by the Reading Center (graders masked).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Corticosteroid-sparing treatment success within the first 6 months after randomization</measure>
    <time_frame>6 months</time_frame>
    <description>Corticosteroid-sparing success is defined as achieving inactive uveitis for two consecutive visits &gt;= 28 days apart while on &lt;= 7.5 mg/day of corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Corticosteroid-sparing treatment success within the first 12 months after randomization</measure>
    <time_frame>12 months</time_frame>
    <description>Corticosteroid-sparing success is defined as achieving inactive uveitis for two consecutive visits &gt;= 28 days apart while on &lt;= 7.5 mg/day of corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prednisone discontinuation success</measure>
    <time_frame>12 months</time_frame>
    <description>Prednisone discontinuation success is defined as achieving inactive uveitis for two consecutive visits &gt;= 28 days apart after discontinuing corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prednisone exposure</measure>
    <time_frame>12 months</time_frame>
    <description>E.g., cumulative prednisone dose and/or mean prednisone dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best corrected visual acuity</measure>
    <time_frame>12 months</time_frame>
    <description>Best corrected visual acuity measured after a standardized refraction using logarithmic visual acuity charts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infections</measure>
    <time_frame>12 months</time_frame>
    <description>Incidence of infections over 12 months of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic adverse events</measure>
    <time_frame>12 months</time_frame>
    <description>Systemic adverse events over 12 months of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Macular edema</measure>
    <time_frame>12 months</time_frame>
    <description>Macular edema over 12 months of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health utility</measure>
    <time_frame>12 months</time_frame>
    <description>Health utility will be measured using the EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generic health-related quality of life</measure>
    <time_frame>12 months</time_frame>
    <description>Generic health-related quality of life will be measured using the SF-36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vision-related quality of life</measure>
    <time_frame>12 months</time_frame>
    <description>Vision-related quality of life will be measured using the NEI-VFQ-25</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">222</enrollment>
  <condition>Uveitis</condition>
  <arm_group>
    <arm_group_label>Adalimumab (ADA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adalimumab administered by subcutaneous injection at dosage and frequency specified below; total duration of treatment is 12 months.&#xD;
Adults (≥ 18 years of age) and adolescents ≥30 kg: 80 mg as initial dose; one week later by 40 mg then 40 mg every two weeks. Adolescents &lt;30 kg: 40 mg as initial dose; one week later 20 mg then 20 mg every 2 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional immunosuppression (CON)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional immunosuppressive agent selected by study ophthalmologist at dose and frequency specified below;12 month treatment duration.&#xD;
Azathioprine: initially 2 mg/kg/day; max dose 200 mg/day. Methotrexate initially 15mg/wk; max dose 25 mg/wk. Mycophenolate initially 1 gm BID; max dose1.5 gm BID. Cyclosporine (Sandimmune - dose 2.5 mg/kg BID and Neoral dose 2 mg/kg BID. Tacrolimus initially 1 mg BID; max dose 3 mg BID.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adalimumab (ADA)</intervention_name>
    <description>Adalimumab is a fully-human monoclonal antibody to TNF-α, which is approved by the U.S. FDA for the treatment of non-infectious intermediate, posterior, and panuveitides in adults and children 2 years of age and older.</description>
    <arm_group_label>Adalimumab (ADA)</arm_group_label>
    <other_name>Adalimumab, Humira</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Conventional immunosuppression (CON)</intervention_name>
    <description>The study ophthalmologist will select amongst the permissible drugs (methotrexate, mycophenolate mofetil or azathioprine for antimetabolites; cyclosporine or tacrolimus for calcineurin inhibitors) taking into account the side effect profile of each drug with respect to subject's clinical situation.</description>
    <arm_group_label>Conventional immunosuppression (CON)</arm_group_label>
    <other_name>Azathioprine, Imuran , Cyclosporine</other_name>
    <other_name>Methotrexate, Rheumatrex</other_name>
    <other_name>Mycophenolate, CellCept</other_name>
    <other_name>Cyclosporine, Sandimmune, Neoral</other_name>
    <other_name>Tacrolimus, Prograf</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Age 13 years or older&#xD;
&#xD;
          2. Weight 30 kg (66 lbs) or greater&#xD;
&#xD;
          3. Active or recently active (≤ 60 days) non-infectious intermediate, posterior, or&#xD;
             panuveitis&#xD;
&#xD;
          4. Prednisone indication meets one of the following:&#xD;
&#xD;
               1. Active uveitis requiring one of the following i. Initiation of prednisone at dose&#xD;
                  greater than 7.5 mg/day ii. Increasing prednisone dose to greater than 7.5 mg/day&#xD;
                  iii. Currently receiving dose greater than 7.5 mg/day&#xD;
&#xD;
               2. Inactive uveitis on current dose greater 7.5 mg/day&#xD;
&#xD;
          5. Initiation or addition of an immunosuppressive drug (i.e., a conventional&#xD;
             immunosuppressive drug or adalimumab) is indicated&#xD;
&#xD;
          6. If currently receiving a conventional immunosuppressive drug, the drug and dose have&#xD;
             been stable for at least 30 days&#xD;
&#xD;
          7. Patient able and willing to self-administer subcutaneous injections or have a&#xD;
             qualified person available to administer subcutaneous injections&#xD;
&#xD;
          8. If posterior segment disease is present, ability to assess activity in at least one&#xD;
             eye with uveitis&#xD;
&#xD;
          9. Visual acuity of light perception or better in at least one eye with uveitis&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-γ&#xD;
             release assay [IGRA] test, such as Quantiferon-gold)&#xD;
&#xD;
          2. Untreated active hepatitis B or C infection&#xD;
&#xD;
          3. Any of the following baseline lab values&#xD;
&#xD;
               1. White blood count &lt;3500 cells per microliter&#xD;
&#xD;
               2. Platelets &lt;100,000 per microliter&#xD;
&#xD;
               3. Hematocrit &lt;30%&#xD;
&#xD;
               4. AST or ALT &gt;1.5X upper limit normal value&#xD;
&#xD;
               5. Serum creatinine &gt;1.1X upper limit normal value&#xD;
&#xD;
          4. Behçet disease&#xD;
&#xD;
          5. Multiple sclerosis or other demyelinating disease&#xD;
&#xD;
          6. For patients with anterior/intermediate or intermediate uveitis without systemic&#xD;
             disease, abnormal magnetic resonance imaging (MRI) of the brain consistent with&#xD;
             demyelinating disease&#xD;
&#xD;
          7. Severe uncontrolled infection&#xD;
&#xD;
          8. Receipt of a live vaccine within past 30 days&#xD;
&#xD;
          9. Moderate to severe heart failure (NYHA class III/IV)&#xD;
&#xD;
         10. Active malignancy&#xD;
&#xD;
         11. Use of anti-TNF monoclonal antibody therapy within past 60 days&#xD;
&#xD;
         12. History of adalimumab intolerance or ineffectiveness&#xD;
&#xD;
         13. Hypersensitivity to any of the study treatments or their excipients&#xD;
&#xD;
         14. Current treatment with an alkylating agent&#xD;
&#xD;
         15. Current treatment with more than one immunosuppressive drug, not including oral&#xD;
             corticosteroids&#xD;
&#xD;
         16. Shorter-acting regional corticosteroids administered within the past 30 days in any&#xD;
             eye(s) with uveitis&#xD;
&#xD;
         17. Long-acting ocular corticosteroid implants, i.e., fluocinolone acetonide implant&#xD;
             (e.g., Retisert®, YutiqTM, Iluvien®) placed within past 3 years unless uveitis is&#xD;
             active in all eye(s) with an implant&#xD;
&#xD;
         18. Systemic disease that is sufficiently active such that it dictates therapy with&#xD;
             systemic corticosteroids or immunosuppressive agents at the time of enrollment&#xD;
&#xD;
         19. Immunodeficiency disease for which immunosuppressive therapy would be contraindicated&#xD;
             according to best medical judgment&#xD;
&#xD;
         20. Pregnancy or lactation&#xD;
&#xD;
         21. For persons of child-bearing potential or impregnating potential, unwillingness to use&#xD;
             appropriate birth control (abstinence, combination barrier and spermicide, hormonal,&#xD;
             or intrauterine device) for the next 18 months or plans to become a biological parent&#xD;
             within the next 18 months.&#xD;
&#xD;
             * In the UK, use of combination barrier and spermicide alone does not meet birth&#xD;
             control requirements.&#xD;
&#xD;
             † UK female study participants must use highly effective methods of contraception.&#xD;
&#xD;
             UK male study participants must use condoms for at least 6 months after the end of&#xD;
             study treatment and their female partners of child-bearing potential are recommended&#xD;
             to use highly effective contraception for the same duration. In addition, male&#xD;
             participants should not donate semen during therapy or for 6 months following&#xD;
             discontinuation of study treatment.&#xD;
&#xD;
         22. Medical problems or drug or alcohol dependence problems sufficient to prevent&#xD;
             adherence to treatment and study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas A Jabs, MD MBA</last_name>
    <role>Study Chair</role>
    <affiliation>CCTand Evidence Synthesis, JHU, Bloomberg School of Public Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Janet T Holbrook, PhD MPH</last_name>
    <phone>443-287-5791</phone>
    <email>jholbro1@jhu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Elizabeth A Sugar, PhD</last_name>
    <email>esugar2@jhu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jules Stein Eye Institute, UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nina Cherian</last_name>
      <phone>310-794-5604</phone>
      <email>NCherian@mednet.ucla.edu</email>
    </contact>
    <investigator>
      <last_name>Gary Holland, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caleb Ebert, MPH</last_name>
      <phone>415-476-6687</phone>
      <email>caleb.ebert@ucsf.edu</email>
    </contact>
    <investigator>
      <last_name>Nisha Acharya, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carmen Huerta</last_name>
      <phone>305-326-6348</phone>
      <email>c.huerta1@med.miami.edu</email>
    </contact>
    <investigator>
      <last_name>Janet Davis, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alcides Fernandes, MD</last_name>
      <phone>404-778-2421</phone>
      <email>afilho@emory.edu</email>
    </contact>
    <investigator>
      <last_name>Ghazala O'Keefe, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chisomo Mwale</last_name>
      <phone>312-695-2567</phone>
      <email>chisomo.mwale@nm.org</email>
    </contact>
    <investigator>
      <last_name>Anjum Koreishi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Preminder (Daisy) Pacelli</last_name>
      <phone>312-563-5537</phone>
      <email>preminder_pacelli@rush.edu</email>
    </contact>
    <investigator>
      <last_name>Pauline T Merrill, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lacy Flanagan, BA</last_name>
      <phone>319-467-5184</phone>
      <email>lacy-flanagan@uiowa.edu</email>
    </contact>
    <investigator>
      <last_name>James Folk, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen Sun</last_name>
      <phone>410-502-1873</phone>
      <email>ksun11@jhu.edu</email>
    </contact>
    <investigator>
      <last_name>Bryn Burkholder, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Eye Institute</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patti Sherry</last_name>
      <phone>301-435-4529</phone>
      <email>sherryp@nei.nih.gov</email>
    </contact>
    <investigator>
      <last_name>Shipla Kodati, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ophthalmic Consultants of Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Meredyth Parsons</last_name>
      <phone>617-314-2703</phone>
      <email>mparsons@eyeboston.com</email>
    </contact>
    <investigator>
      <last_name>Lana M Rifkin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Michigan Health System, Kellogg Eye Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pamela Campbell</last_name>
      <phone>734-936-0138</phone>
      <email>pamtitus@med.umich.edu</email>
    </contact>
    <investigator>
      <last_name>Susan G Elner, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sandy Quirin</last_name>
      <email>squirin@wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Lynn Hassman, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexis Giron</last_name>
      <phone>215-662-9393</phone>
      <email>Alexis.Giron@Pennmedicine.upenn.edu</email>
    </contact>
    <investigator>
      <last_name>Nirali Bhatt, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MidAtlantic Retina, Wills Eye Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brianna Kenney</last_name>
      <phone>215-928-3092</phone>
      <email>bkenney@midatlanticretina.com</email>
    </contact>
    <investigator>
      <last_name>James P Dunn, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rhonda Dahlstrom</last_name>
      <phone>412-647-3434</phone>
      <email>dahlstromrj@upmc.edu</email>
    </contact>
    <investigator>
      <last_name>Marie-Helene Errera, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tennessee Retina</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Lisa Walden</last_name>
      <phone>615-345-8912</phone>
      <email>lwalden@tnretina.com</email>
    </contact>
    <investigator>
      <last_name>Akshay Thomas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Eye Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Crystal Nicholson</last_name>
      <phone>615-936-0971</phone>
      <email>crystal.nicholson@vumc.org</email>
    </contact>
    <contact_backup>
      <last_name>Saige Wilkins</last_name>
      <phone>619-936-1474</phone>
      <email>saige.wilkins@vumc.org</email>
    </contact_backup>
    <investigator>
      <last_name>Sapna Gangaputra, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Retinal Consultants of Texas</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chelsey Moore</last_name>
      <phone>713-524-3434</phone>
      <email>chelsey.moore@houstonretina.com</email>
    </contact>
    <investigator>
      <last_name>Rosa Y Kim, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Utah, Moran Eye Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kimberley Wegner, BS, CRC</last_name>
      <phone>801-581-6265</phone>
      <email>kimberley.wegner@hsc.utah.edu</email>
    </contact>
    <investigator>
      <last_name>Albert Vitale, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Washington, Medicine Eye Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ian Luttrell</last_name>
      <phone>206-520-9728</phone>
      <email>luttri@uw.edu</email>
    </contact>
    <investigator>
      <last_name>Kathryn Pepple, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre for Eye Research Australia</name>
      <address>
        <city>East Melbourne</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thuy Chau</last_name>
      <phone>+61 3 9929 8087</phone>
      <email>thuy.chau@unimelb.edu.au</email>
    </contact>
    <investigator>
      <last_name>Lyndell Lim, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Sydney</name>
      <address>
        <city>Sydney</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nina Mustafic</last_name>
      <phone>+61 2 9362 7300</phone>
      <email>nina.mustafic@sydney.edu.au</email>
    </contact>
    <investigator>
      <last_name>Peter McCluskey</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>McGill University</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4A 3S5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Isabelle Delpech</last_name>
      <phone>(514)934-1934</phone>
      <phone_ext>36814</phone_ext>
      <email>isabelle.delpech@muhc.mcgill.ca</email>
    </contact>
    <investigator>
      <last_name>Jean Deschenes, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Birmingham</name>
      <address>
        <city>Edgbaston</city>
        <state>Birmingham</state>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Claire L Arthur</last_name>
      <phone>+441213718757</phone>
      <email>claire.arthur@uhb.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Alastair Denniston, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bradford Teaching Hospital NHS Foundation Trust</name>
      <address>
        <city>Bradford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nicci Hawes</last_name>
      <phone>01274 27 6376</phone>
      <email>nicola.hawes@bthft.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Helen Devenport</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cambridge University NHS Trust</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Paula Tunrbull</last_name>
      <phone>01223 586526</phone>
      <email>paula.turnbull@addenbrookes.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Erika Damato, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Leicester</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Carol Betteridge</last_name>
      <email>Carol.Betteridge@uhl-tr.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Lauren Rybicki</last_name>
      <email>lauren.rybicki@uhl-tr.nhs.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Periyasamy Kumar, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Moorfields Eye Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>EC1V 9EL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Flora Kakanou</last_name>
      <email>flora.kakanou@nhs.net</email>
    </contact>
    <investigator>
      <last_name>William Tucker, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>June 16, 2022</last_update_submitted>
  <last_update_submitted_qc>June 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uveitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclosporine</mesh_term>
    <mesh_term>Adalimumab</mesh_term>
    <mesh_term>Methotrexate</mesh_term>
    <mesh_term>Azathioprine</mesh_term>
    <mesh_term>Tacrolimus</mesh_term>
    <mesh_term>Cyclosporins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>A public use dataset corresponding to the primary manuscript and compliant with HIPAA regulations will be prepared within 1 year of completion of data collection. An encrypted data set containing de-identified data, a data dictionary and other study documentation (e.g. protocol and study manuals) will be provide after the data use agreement has been executed (see access criteria below).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>One year after completion of data collection, the data set will be available upon request .</ipd_time_frame>
    <ipd_access_criteria>Requests for access to data will be reviewed by the Executive Committee to confirm oversight authority approval (e.g. IRB approval) and a minimum standard of scientific merit. Once a request is approved, the investigator will be required to sign a data use agreement approved by the Johns Hopkins Bloomberg School of Public Health Office of Research Administration. An encrypted data set containing de-identified data, a data dictionary and other study documentation (e.g. protocol and study manuals) will be provide after the data use agreement has been executed.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03828019
org study id: 9196
nct id: NCT03828019
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Non-infectious intermediate, posterior, and panuveitides are chronic, potentially-blinding
      diseases. Vision-threatening cases require long-term therapy with oral corticosteroids and
      immunosuppression. Based upon preliminary data, adalimumab, a fully-human, anti-TNF-α
      monoclonal antibody, now US FDA-approved for uveitis treatment, may be a superior
      corticosteroid-sparing agent than conventional immunosuppressive drugs. The ADVISE Trial is
      multicenter randomized, parallel-treatment, comparative effectiveness trial comparing
      adalimumab to conventional (small molecule) immunosuppression for corticosteroid spring in
      the treatment of non-infectious, intermediate, posterior, and panuveitides.
Abstract from protocol: The uveitides are a collection of diseases characterized by
      intraocular inflammation. Collectively, they are the 5th leading cause of blindness in the
      US, and the estimated cost of treating them is similar to that of treating diabetic
      retinopathy. Non-infectious intermediate, posterior, and panuveitides have the highest rates
      of visual loss and typically are treated with oral corticosteroids and immunosuppression. The
      Multicenter Uveitis Steroid Treatment (MUST) Trial (a randomized, comparative effectiveness
      trial, which compared 2 treatment paradigms for these diseases, systemic therapy with
      corticosteroids and immunosuppression vs. regional therapy [the fluocinolone acetonide
      implant]), and Follow-up Study demonstrated the superiority of the systemic approach to the
      regional ocular approach in terms of long-term visual outcomes with essentially no increase
      in systemic side effects in the systemic group. One key to systemic therapy's success was the
      use of systemic immunosuppression in 88% of participants, coupled with tapering the
      prednisone to <7.5 mg/day, a relatively safe dose. Non-alklyating agents are typically the
      first choice and the most often used are azathioprine, methotrexate, mycophenolate,
      cyclosporine, and tacrolimus. The alkylating agents, cyclophosphamide and chlorambucil, are
      used less often because of concerns about potential increased malignancy risk. Data from the
      Systemic Immunosuppressive Therapy for Eye Diseases (SITE) Cohort Study suggest that each of
      the conventional, non-alkylating agent immunosuppressive drugs is effective in controlling
      the inflammation while permitting tapering prednisone in ~40-55% of patients; hence
      combination therapy often is needed. Furthermore, minimizing the daily dose of prednisone is
      important, as the risk of cardiovascular disease and mortality increase with the cumulative
      dose of oral corticosteroids. In June 2016, the fully-human, anti-TNF-α monoclonal antibody,
      adalimumab, was approved by the US Food and Drug Administration (FDA) for the treatment of
      uveitis. Anti-TNF-α monoclonal antibody therapy has revolutionized the management of the
      rheumatic diseases largely due to its superior efficacy compared to conventional Disease
      Modifying Anti-Rheumatic Drugs. Data from VISUAL III, the extension of the two phase 3 trials
      that led to the FDA approval of adalimumab for the treatment of uveitis, suggest that
      adalimumab may be superior to conventional immunosuppression, as ~75% of participants had
      controlled inflammation with prednisone doses <5 mg/day. The ADalimumab Vs. conventional
      ImmunoSupprEssion for uveitis (ADVISE) Trial is a randomized, comparative effectiveness trial
      comparing adalimumab to conventional agent immunosuppression for patients with
      non-infectious, intermediate, posterior, and panuveitides. The primary outcome is the ability
      to successfully taper prednisone to <7.5 mg/day by 6 months after randomization while
      maintaining control of the inflammation. Secondary outcomes include prednisone
      discontinuation by 1 year, visual acuity, and complications of uveitis and its treatment.

      ADVISE is being conducted under IND 132532. Adalimumab was FDA approved for the treatment of
      non-infectious intermediate, posterior, and panuveitides in adult patients in 2016 and in
      pediatric patients 2 years of age and older in 2018. In 2016, prior to the approval for
      pediatric patients, the FDA determined that use of adalimumab for the treatment of
      non-infectious intermediate, posterior, and panuveitides in adolescent patients in the ADVISE
      Trial does not increase risk for these patients as the drug is approved for treatment of
      pediatric patients for other indications. Although conventional immunosuppressive drugs are
      the standard approach and in widespread use, these drugs are not FDA approved for treatment
      of non-infectious intermediate, posterior, and panuveitides, and therefore an IND has been
      issued for this trial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized treatment assignment with allocation ratio: 1:1 and two stratification variables: (1) number of immunosuppressive drug patient is on at time of enrollment (zero vs. one); (2) Initial dose of prednisone patient will be on in trial (<30 mg/day vs. ≥30 mg/day). The unit of randomization is the patient,
primary purpose: Treatment
masking: None (Open Label)
masking description: Unmasked treatment administration and outcome assessments (participants, study ophthalmologists, visual function examiners, and study coordinators are all unmasked). Masked assessment of baseline, 1-month, 3-month, and 6-month photographic images and OCT by the Reading Center (graders masked).
measure: Corticosteroid-sparing treatment success within the first 6 months after randomization
time frame: 6 months
description: Corticosteroid-sparing success is defined as achieving inactive uveitis for two consecutive visits >= 28 days apart while on <= 7.5 mg/day of corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging.
measure: Corticosteroid-sparing treatment success within the first 12 months after randomization
time frame: 12 months
description: Corticosteroid-sparing success is defined as achieving inactive uveitis for two consecutive visits >= 28 days apart while on <= 7.5 mg/day of corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging.
measure: Prednisone discontinuation success
time frame: 12 months
description: Prednisone discontinuation success is defined as achieving inactive uveitis for two consecutive visits >= 28 days apart after discontinuing corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging.
measure: Prednisone exposure
time frame: 12 months
description: E.g., cumulative prednisone dose and/or mean prednisone dose
measure: Best corrected visual acuity
time frame: 12 months
description: Best corrected visual acuity measured after a standardized refraction using logarithmic visual acuity charts
measure: Infections
time frame: 12 months
description: Incidence of infections over 12 months of follow-up
measure: Systemic adverse events
time frame: 12 months
description: Systemic adverse events over 12 months of follow-up
measure: Macular edema
time frame: 12 months
description: Macular edema over 12 months of follow-up
measure: Health utility
time frame: 12 months
description: Health utility will be measured using the EQ-5D
measure: Generic health-related quality of life
time frame: 12 months
description: Generic health-related quality of life will be measured using the SF-36
measure: Vision-related quality of life
time frame: 12 months
description: Vision-related quality of life will be measured using the NEI-VFQ-25
arm group label: Adalimumab (ADA)
arm group type: Active Comparator
description: Adalimumab administered by subcutaneous injection at dosage and frequency specified below; total duration of treatment is 12 months.
Adults (≥ 18 years of age) and adolescents ≥30 kg: 80 mg as initial dose; one week later by 40 mg then 40 mg every two weeks. Adolescents <30 kg: 40 mg as initial dose; one week later 20 mg then 20 mg every 2 weeks.
arm group label: Conventional immunosuppression (CON)
arm group type: Active Comparator
description: Conventional immunosuppressive agent selected by study ophthalmologist at dose and frequency specified below;12 month treatment duration.
Azathioprine: initially 2 mg/kg/day; max dose 200 mg/day. Methotrexate initially 15mg/wk; max dose 25 mg/wk. Mycophenolate initially 1 gm BID; max dose1.5 gm BID. Cyclosporine (Sandimmune - dose 2.5 mg/kg BID and Neoral dose 2 mg/kg BID. Tacrolimus initially 1 mg BID; max dose 3 mg BID.
intervention type: Biological
intervention name: Adalimumab (ADA)
description: Adalimumab is a fully-human monoclonal antibody to TNF-α, which is approved by the U.S. FDA for the treatment of non-infectious intermediate, posterior, and panuveitides in adults and children 2 years of age and older.
arm group label: Adalimumab (ADA)
other name: Adalimumab, Humira
intervention type: Drug
intervention name: Conventional immunosuppression (CON)
description: The study ophthalmologist will select amongst the permissible drugs (methotrexate, mycophenolate mofetil or azathioprine for antimetabolites; cyclosporine or tacrolimus for calcineurin inhibitors) taking into account the side effect profile of each drug with respect to subject's clinical situation.
arm group label: Conventional immunosuppression (CON)
other name: Azathioprine, Imuran , Cyclosporine
other name: Methotrexate, Rheumatrex
other name: Mycophenolate, CellCept
other name: Cyclosporine, Sandimmune, Neoral
other name: Tacrolimus, Prograf
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: No
last name: Douglas A Jabs, MD MBA
role: Study Chair
affiliation: CCTand Evidence Synthesis, JHU, Bloomberg School of Public Health
last name: Janet T Holbrook, PhD MPH
phone: 443-287-5791
email: jholbro1@jhu.edu
last name: Elizabeth A Sugar, PhD
email: esugar2@jhu.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: Australia
country: Canada
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Uveitis
mesh term: Cyclosporine
mesh term: Adalimumab
mesh term: Methotrexate
mesh term: Azathioprine
mesh term: Tacrolimus
mesh term: Cyclosporins
sharing ipd: Yes
ipd description: A public use dataset corresponding to the primary manuscript and compliant with HIPAA regulations will be prepared within 1 year of completion of data collection. An encrypted data set containing de-identified data, a data dictionary and other study documentation (e.g. protocol and study manuals) will be provide after the data use agreement has been executed (see access criteria below).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: One year after completion of data collection, the data set will be available upon request .
ipd access criteria: Requests for access to data will be reviewed by the Executive Committee to confirm oversight authority approval (e.g. IRB approval) and a minimum standard of scientific merit. Once a request is approved, the investigator will be required to sign a data use agreement approved by the Johns Hopkins Bloomberg School of Public Health Office of Research Administration. An encrypted data set containing de-identified data, a data dictionary and other study documentation (e.g. protocol and study manuals) will be provide after the data use agreement has been executed.