<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/NCT01693640</url>
  </required_header>
  <id_info>
    <org_study_id>10-02611</org_study_id>
    <nct_id>NCT01693640</nct_id>
  </id_info>
  <brief_title>A Pilot Study of the Safety and Efficacy of Abatacept Injections in the Treatment of Behcet's Syndrome</brief_title>
  <official_title>A Pilot Study of the Safety and Efficacy of Abatacept Injections in the Treatment of Mucocutaneous Manifestations of Behcet's Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</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>
      Hypothesis: Abatacept injections will decrease the number of oral ulcers seen in Behcet's&#xD;
      patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be an open label study, where 20 Behcet's patients with resistant oral ulcers and&#xD;
      10 with resistant genital ulcers will be enrolled (screen 40). After enrollment all patients&#xD;
      will be followed for a month to document the number of oral and genital ulcers on their&#xD;
      current regimen. Then all patients will receive abatacept for 6 months (evaluated at weeks 0,&#xD;
      2, 4, 8, 12, 16 and 24). Then the treatment will be stopped and they will be observed for the&#xD;
      next 2 months, for a total of 9 month trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2012</start_date>
  <completion_date type="Actual">December 28, 2018</completion_date>
  <primary_completion_date type="Actual">December 28, 2018</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ulcers</measure>
    <time_frame>6 month treatment period</time_frame>
    <description>The primary endpoint is number of oral and genital ulcers (AUC) during the treatment period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Genital ulcers</measure>
    <time_frame>6 month treatment</time_frame>
    <description>Number of genital ulcers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment failures</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients who fail to complete 6 months (treatment failures)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral ulcer pain</measure>
    <time_frame>6 months</time_frame>
    <description>Oral ulcer pain-Visual Analog Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side Effects</measure>
    <time_frame>6 months</time_frame>
    <description>Monitoring of side effects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MDHAQ</measure>
    <time_frame>6 months</time_frame>
    <description>Multidimensional health assessment questionnaire (MDHAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BSAS</measure>
    <time_frame>6 months</time_frame>
    <description>Behcet's syndrome activity score (BSAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BDCAF</measure>
    <time_frame>6 months</time_frame>
    <description>Behcet's disease current activity form (BDCAF) scores</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Female Patients With Behcet's Syndrome</condition>
  <arm_group>
    <arm_group_label>abatacept</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abatacept</intervention_name>
    <description>Weekly injections with Abatacept 125 mg over 6 months</description>
    <arm_group_label>abatacept</arm_group_label>
    <other_name>Orencia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Before any study procedures are performed, subjects will have the details of the study&#xD;
             described to them, and they will be given a written informed consent document to read.&#xD;
             Then, if subjects consent to participate in the study, they will indicate that consent&#xD;
             by signing and dating the informed consent document in the presence of study&#xD;
             personnel.&#xD;
&#xD;
          2. Female patients with a diagnosis of Behcet's syndrome&#xD;
&#xD;
          3. Women, greater than 18 years of age&#xD;
&#xD;
          4. Women of childbearing potential (WOCBP) must be using an adequate method of&#xD;
             contraception to avoid pregnancy throughout the study and for up to 10 weeks after the&#xD;
             last dose of study drug to minimize the risk of pregnancy.&#xD;
&#xD;
          5. Patients must have oral ulcers or genital ulcers that have been resistant to&#xD;
             colchicine or topical measures for at least a month.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for&#xD;
             the entire study period and for up to 10 weeks after the last dose of study drug.&#xD;
&#xD;
          2. Women who are pregnant or breastfeeding.&#xD;
&#xD;
          3. Women with a positive pregnancy test on enrollment or before administration of&#xD;
             abatacept.&#xD;
&#xD;
             Target Disease Exceptions [Include as applicable]&#xD;
&#xD;
               -  Any patients with systemic manifestations of Behcet's syndrome (Patients with&#xD;
                  eye, CNS, vascular involvement, gastrointestinal disease)&#xD;
&#xD;
               -  Patients who are already on other immunosuppressive medications (azathioprine,&#xD;
                  TNF inhibitors, other biologic agents, methotrexate, mycophenolate mofetil,&#xD;
                  cyclosporine, cyclophosphamide)&#xD;
&#xD;
          4. Subjects who are impaired, incapacitated, or incapable of completing study-related&#xD;
             assessments.&#xD;
&#xD;
          5. Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic,&#xD;
             hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease,&#xD;
             whether or not related to Behcet's syndrome and which, in the opinion of the&#xD;
             investigator, might place a subject at unacceptable risk for participation in the&#xD;
             study.&#xD;
&#xD;
          6. Female subjects who have had a breast cancer screening that is suspicious for&#xD;
             malignancy and in whom the possibility of malignancy cannot be reasonably excluded by&#xD;
             additional clinical, laboratory, or other diagnostic evaluations.&#xD;
&#xD;
          7. Subjects with a history of cancer in the last 5 years, other than non-melanoma skin&#xD;
             cell cancers cured by local resection or carcinoma in situ.&#xD;
&#xD;
          8. Subjects who currently abuse drugs or alcohol.&#xD;
&#xD;
          9. Subjects with evidence (as assessed by the investigator) of active or latent bacterial&#xD;
             or viral infections at the time of potential enrollment, including subjects with&#xD;
             evidence of human immunodeficiency virus (HIV) detected during screening.&#xD;
&#xD;
         10. Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months&#xD;
             before the informed consent document was signed.&#xD;
&#xD;
         11. Subjects who have received any live vaccines within 3 months of the anticipated first&#xD;
             dose of study medication.&#xD;
&#xD;
         12. Subjects with any serious bacterial infection within the last 3 months, unless treated&#xD;
             and resolved with antibiotics, or any chronic bacterial infection (eg, chronic&#xD;
             pyelonephritis, osteomyelitis, or bronchiectasis).&#xD;
&#xD;
         13. Subjects at risk for tuberculosis (TB).&#xD;
&#xD;
         14. Subjects must not be positive for hepatitis B surface antigen.&#xD;
&#xD;
         15. Subjects who are positive for hepatitis C antibody if the presence of hepatitis C&#xD;
             virus was also shown with polymerase chain reaction or recombinant immunoblot assay.&#xD;
&#xD;
         16. Subjects with any of the following laboratory values&#xD;
&#xD;
         17. Hemoglobin &lt; 8.5 g/dL&#xD;
&#xD;
         18. WBC &lt; 3000/mm3 (&lt; 3 x 109/L)&#xD;
&#xD;
         19. Platelets &lt; 100,000/mm3 (&lt; 3 x 109/L)&#xD;
&#xD;
         20. Serum creatinine &gt; 2 times the ULN&#xD;
&#xD;
         21. Serum ALT or AST &gt; 2 times the ULN&#xD;
&#xD;
         22. Any other laboratory test results that, in the opinion of the investigator, might&#xD;
             place a subject at unacceptable risk for participation in the study.&#xD;
&#xD;
         23. Subjects who have at any time received treatment with any investigational drug within&#xD;
             28 days (or less than 5 terminal half-lives of elimination) of the Day 1 dose.&#xD;
&#xD;
         24. Any concomitant biologic DMARD.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>NYU Center for Musculoskeletal Care</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://redaf.med.nyu.edu/musculoskeletal-institute-%E2%80%93-333-east-38th-street</url>
    <description>NYU Center for Musculoskeletal Care</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Behcet's</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behcet Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abatacept</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01693640
org study id: 10-02611
nct id: NCT01693640
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Hypothesis: Abatacept injections will decrease the number of oral ulcers seen in Behcet's
      patients
This will be an open label study, where 20 Behcet's patients with resistant oral ulcers and
      10 with resistant genital ulcers will be enrolled (screen 40). After enrollment all patients
      will be followed for a month to document the number of oral and genital ulcers on their
      current regimen. Then all patients will receive abatacept for 6 months (evaluated at weeks 0,
      2, 4, 8, 12, 16 and 24). Then the treatment will be stopped and they will be observed for the
      next 2 months, for a total of 9 month trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ulcers
time frame: 6 month treatment period
description: The primary endpoint is number of oral and genital ulcers (AUC) during the treatment period
measure: Genital ulcers
time frame: 6 month treatment
description: Number of genital ulcers
measure: Treatment failures
time frame: 6 months
description: Number of patients who fail to complete 6 months (treatment failures)
measure: Oral ulcer pain
time frame: 6 months
description: Oral ulcer pain-Visual Analog Scale (VAS)
measure: Side Effects
time frame: 6 months
description: Monitoring of side effects
measure: MDHAQ
time frame: 6 months
description: Multidimensional health assessment questionnaire (MDHAQ)
measure: BSAS
time frame: 6 months
description: Behcet's syndrome activity score (BSAS)
measure: BDCAF
time frame: 6 months
description: Behcet's disease current activity form (BDCAF) scores
arm group label: abatacept
arm group type: Experimental
intervention type: Drug
intervention name: Abatacept
description: Weekly injections with Abatacept 125 mg over 6 months
arm group label: abatacept
other name: Orencia
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
url: http://redaf.med.nyu.edu/musculoskeletal-institute-%E2%80%93-333-east-38th-street
description: NYU Center for Musculoskeletal Care
responsible party type: Sponsor
mesh term: Behcet Syndrome
mesh term: Syndrome
mesh term: Abatacept