xml: <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/NCT06016517</url>
    </required_header>
    <id_info>
      <org_study_id>00003917</org_study_id>
      <nct_id>NCT06016517</nct_id>
    </id_info>
    <brief_title>Application of N-of-1 Rheumatoid Arthritis</brief_title>
    <official_title>Application of the N-of-1 Trial Design in Rheumatoid Arthritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tufts Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tufts Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this N-of-1 study is to learn about treatment for individual patients who have&#xD;
        rheumatoid arthritis (RA,) for which many treatments are available. The treatments are&#xD;
        different in how they work, the way they are given, side- effects, and cost. While treatment&#xD;
        guidelines are available, finding the best treatment order of treatments is often based on&#xD;
        physician choice. The main question this study aims to answer are:&#xD;
  &#xD;
          -  What are the effects of different treatments on RA symptoms and condition for each&#xD;
             individual patient&#xD;
  &#xD;
          -  What is the effectiveness of different treatments across all patients enrolled in the&#xD;
             N-of-1 study&#xD;
  &#xD;
        Participants will be enrolled and randomized to a sequence of three U.S. Food and Drug&#xD;
        Administration (FDA) approved RA medications: 1. adalimumab, 2. sarilumab, and 3.&#xD;
        upadacitinib. Participants will be asked to complete questionnaires about their condition and&#xD;
        quality of life weekly (either in clinic or remotely) and report their level of pain daily&#xD;
        (remotely).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rheumatoid arthritis (RA) is a chronic, slowly progressive condition for which numerous&#xD;
        treatment options are available. The therapies vary in mechanism of action, mode of&#xD;
        administration, side- effect (adverse event) profile, and cost. While consensus treatment&#xD;
        guidelines are available, identifying an optimal treatment sequence is often based on&#xD;
        clinician choice with treatment changes based on tolerability and short- term outcome. The&#xD;
        N-of-1 trial will evaluate individual participant and aggregate data.&#xD;
  &#xD;
        Individual participants will be enrolled and randomized to a sequence of three U.S. Food and&#xD;
        Drug Administration (FDA)-approved therapeutic agents - adalimumab, sarilumab, upadacitinib-&#xD;
        plus matching placebos to enable blinding of patients, clinicians, and study personnel.&#xD;
  &#xD;
        The N-of-1- RA protocol describes patient allocation into a series of individual randomized&#xD;
        comparisons. These treatment conditions are double-blind and randomized, with inclusion of&#xD;
        matching parallel placebo treatments identical in appearance to the active medications:&#xD;
  &#xD;
        • Patients with newly diagnosed rheumatoid arthritis following initial treatment with&#xD;
        methotrexate (MTX). Prior to randomization, participants will be allocated to:&#xD;
  &#xD;
          -  MTX responder&#xD;
  &#xD;
          -  MTX non- responder&#xD;
  &#xD;
        Eligible participants will either continue MTX or discontinue MTX, based on response to&#xD;
        initial therapy and tolerance. Participants identified for subsequent biologic therapy will&#xD;
        enter the blinded biologic therapy phase of the study; with MTX either continued or not&#xD;
        continued. This phase consists of a sequence of 3 therapeutic intervention regimens, each&#xD;
        lasting 12-weeks. Each treatment period includes matching parallel placebo treatments&#xD;
        identical to the active medications in appearance to ensure blinding of patients, clinicians,&#xD;
        and study personnel.&#xD;
  &#xD;
        The treatment conditions are as follows:&#xD;
  &#xD;
        A. Tumor Necrosis Factor (TNF) Inhibitor biologic: Adalimumab 40 mg subcutaneously every 2&#xD;
        weeks via subcutaneous injection with oral placebo once daily.&#xD;
  &#xD;
        B. Non-TNF-Inhibitor biologic: Sarilumab 200 mg via subcutaneous injection every 2 weeks with&#xD;
        oral placebo once daily.&#xD;
  &#xD;
        C. Janus Kinase (JAK) Inhibitor: Upadacitinib 15 mg orally once daily with subcutaneous&#xD;
        placebo injection every 2 weeks.&#xD;
  &#xD;
        Primary Objective (individual N-of-1 trial): To generate randomized evidence about the&#xD;
        effects of therapeutic agents on RA symptoms and disease activity to inform decision about&#xD;
        best treatment at the end of the trial period for each participant.&#xD;
  &#xD;
        Secondary Objective (aggregation of the series of N-of-1 trials): To evaluate the average&#xD;
        relative effectiveness of therapeutic agents across all participants and explore&#xD;
        heterogeneity of treatment effects.&#xD;
  &#xD;
        For the aggregated series of N-of-1 trial, we will use the following hierarchy of endpoints.&#xD;
  &#xD;
          -  Primary Endpoint:&#xD;
  &#xD;
          -  DAS28 (CRP)&#xD;
  &#xD;
          -  Secondary Endpoints including:&#xD;
  &#xD;
          -  American College of Rheumatology 20% (ACR20), 50% (ACR50) and 70% (ACR70) response&#xD;
  &#xD;
          -  Routine Assessment of Patient Index Data (RAPID3) score based on participants' report of&#xD;
             overall assessment of the disease, the level of pain, and the amount of physical&#xD;
             disability&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Disease Activity Score (DAS) 28</measure>
      <time_frame>Baseline and at week 4, 8 and 12</time_frame>
      <description>Evaluates patient and physician overall assessment of disease activity, including the number of swollen and painful joints (out of 28 joints),</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in The Routine Assessment of Patient Index Data 3 (RAPID3)</measure>
      <time_frame>Baseline and at week 4, 6, 8, 10 and 12</time_frame>
      <description>Assessment of a) function, b) pain, and c) patient global estimate of status</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in American College of Rheumatology 20 (ACR20)</measure>
      <time_frame>Baseline and at week 4, 8 and 12</time_frame>
      <description>≥20% fewer tender and swollen joints and ≥20% improvement in three of five other domains; a) patient global assessment, b) physician global assessment, c) functional questionnaire, d) pain score, and f) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in American College of Rheumatology 50 (ACR50)</measure>
      <time_frame>Baseline and at week 4, 8 and 12</time_frame>
      <description>≥50% fewer tender and swollen joints and ≥20% improvement in three of five other domains; a) patient global assessment, b) physician global assessment, c) functional questionnaire, d) pain score, and f) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in American College of Rheumatology 70 (ACR70)</measure>
      <time_frame>Baseline and at week 4, 8 and 12</time_frame>
      <description>≥70% fewer tender and swollen joints and ≥20% improvement in three of five other domains; a) patient global assessment, b) physician global assessment, c) functional questionnaire, d) pain score, and f) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Medical Outcome Study Short-Form 12- item Health Survey (SF-12)</measure>
      <time_frame>Baseline and at week 4, 6, 8, 10 and 12</time_frame>
      <description>General Health Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient-Reported Measure of Physical Function (PROMIS) PF10a</measure>
      <time_frame>Baseline and at week 4, 6, 8, 10 and 12</time_frame>
      <description>Patient self- assessment of function</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Burden Questionnaire (TBQ)</measure>
      <time_frame>At End of Treatment</time_frame>
      <description>Assessment of the burden associated with taking medicine, self-monitoring, laboratory tests, doctor visits, need for organization, administrative tasks, following advice on diet and physical activity, and social impact of treatment.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Arthritis, Rheumatoid</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Adalimumab</intervention_name>
      <description>40 mg subcutaneously every 2 weeks with oral placebo once daily</description>
      <other_name>Humira</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sarilumab</intervention_name>
      <description>200 mg subcutaneously every 2 weeks with oral placebo once daily</description>
      <other_name>Kevzara</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Upadacitinib</intervention_name>
      <description>15 mg orally once daily with subcutaneous placebo injection every 2 weeks</description>
      <other_name>Rinvoq</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Study participants will be individuals with newly- diagnosed RA, based on established&#xD;
          clinical, radiologic, and laboratory criteria. Patients who are candidates for&#xD;
          disease-modifying pharmacologic treatment will be offered the option of participating in&#xD;
          the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Newly diagnosed adult-onset Rheumatoid Arthritis (RA) as defined by the American&#xD;
               College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2021 Criteria&#xD;
               for the Classification of RA&#xD;
  &#xD;
                 -  Moderately to severely active RA defined as the presence of at least 6/68 tender&#xD;
                    joints and at least 6/66 swollen joints&#xD;
  &#xD;
                 -  C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP)&#xD;
                    measurement ≥ 1 time the upper limit of normal&#xD;
  &#xD;
                 -  First-line therapy with MTX for at least the 12 weeks prior to study entry with a&#xD;
                    continuous, non-changing dose for at least 8 weeks prior to study entry but&#xD;
                    continue to exhibit active RA&#xD;
  &#xD;
                 -  Had to discontinue MTX due to intolerability or toxicity, irrespective of&#xD;
                    treatment duration&#xD;
  &#xD;
                 -  Have never received adalimumab, sarilumab, upadacitinib prior to first dose of&#xD;
                    study drug.&#xD;
  &#xD;
                 -  Provision of informed consent&#xD;
  &#xD;
                 -  Stated willingness to comply with all study procedures and availability for the&#xD;
                    duration of the study&#xD;
  &#xD;
                 -  18 years of age or older&#xD;
  &#xD;
                 -  Ability to take oral medication and be willing to adhere to the three treatment&#xD;
                    periods&#xD;
  &#xD;
                 -  Patients are eligible whether their disease responded adequately or inadequately&#xD;
                    to first-line MTX or if they were intolerant to first-line MTX.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • History of any arthritis with onset prior to age 17 years or current diagnosis of&#xD;
               inflammatory joint disease other than RA&#xD;
  &#xD;
                 -  Has received intra-articular, intravenous, intramuscular corticosteroids within&#xD;
                    28 days prior to baseline&#xD;
  &#xD;
                 -  Known allergic reactions to components of any of the three biologic agents&#xD;
  &#xD;
                 -  Is currently receiving corticosteroids at doses &gt; (greater than) 10 mg per day of&#xD;
                    prednisone (or equivalent) or have been receiving an unstable dosing regimen of&#xD;
                    corticosteroids within 2 weeks of study entry or within 6 weeks of planned&#xD;
                    randomization&#xD;
  &#xD;
                 -  Has experienced any of the following within 12 weeks of study entry: myocardial&#xD;
                    infarction, unstable ischemic heart disease, stroke, or have New York Heart&#xD;
                    Association stage IV heart failure&#xD;
  &#xD;
                 -  Tuberculosis infection&#xD;
  &#xD;
                 -  Hepatitis B or C infection&#xD;
  &#xD;
                 -  History of venous thromboembolic event (deep vein thrombosis, pulmonary embolism)&#xD;
  &#xD;
                 -  Has a history or presence of cardiovascular, respiratory, hepatic,&#xD;
                    gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric&#xD;
                    disorders or any other serious and/or unstable illness that, in the opinion of&#xD;
                    the investigator, could constitute a risk or could interfere with the&#xD;
                    interpretation of data&#xD;
  &#xD;
                 -  Has an estimated glomerular filtration rate (eGFR) based on the most recent&#xD;
                    available serum creatinine of &lt; (less than) 40 milliliter per minute per 1.73 m^2&#xD;
                    (mL/min/1.73 m^2)&#xD;
  &#xD;
                 -  Has a history of chronic liver disease with the most recent available aspartate&#xD;
                    aminotransferase (AST) or alanine aminotransferase (ALT) &gt;1.5 times the ULN or&#xD;
                    the most recent available total bilirubin ≥1.5 times the ULN&#xD;
  &#xD;
                 -  Has a history of, lymphoproliferative disease; or have signs or symptoms&#xD;
                    suggestive of possible lymphoproliferative disease, including lymphadenopathy or&#xD;
                    splenomegaly; or have active primary or recurrent malignant disease; or have been&#xD;
                    in remission from clinically significant malignancy for &lt;5 years&#xD;
  &#xD;
                 -  Has been exposed to a live vaccine within 12 weeks prior to planned randomization&#xD;
                    or are expected to need/receive a live vaccine during the course of the study&#xD;
                    (with the exception of herpes zoster vaccination)&#xD;
  &#xD;
                 -  Has a current or recent clinically serious viral, bacterial, fungal, or parasitic&#xD;
                    infection&#xD;
  &#xD;
                 -  Has had symptomatic herpes zoster infection within 12 weeks prior to study entry&#xD;
  &#xD;
                 -  Is immunocompromised and, in the opinion of the investigator, are at an&#xD;
                    unacceptable risk for participating in the study&#xD;
  &#xD;
                 -  Has a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or&#xD;
                    human immunodeficiency virus (HIV)&#xD;
  &#xD;
                 -  Has evidence of active or latent tuberculosis (TB)&#xD;
  &#xD;
                 -  Current hospitalization or requiring hospital admission at screening&#xD;
  &#xD;
                 -  Pregnant or breastfeeding&#xD;
  &#xD;
                 -  Participation in another therapeutic clinical trial for RA&#xD;
  &#xD;
                 -  Lack of internet access to telehealth platform&#xD;
  &#xD;
                 -  Non-English speaking participants&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dorothy Dulko</last_name>
      <phone>6176365009</phone>
      <email>ddulko@tuftsmedicalcenter.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tufts Medical Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02111</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</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>Arthritis</mesh_term>
      <mesh_term>Arthritis, Rheumatoid</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adalimumab</mesh_term>
      <mesh_term>Upadacitinib</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016517
  org study id: 00003917
  nct id: NCT06016517
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this N-of-1 study is to learn about treatment for individual patients who have
        rheumatoid arthritis (RA,) for which many treatments are available. The treatments are
        different in how they work, the way they are given, side- effects, and cost. While treatment
        guidelines are available, finding the best treatment order of treatments is often based on
        physician choice. The main question this study aims to answer are:
  
          -  What are the effects of different treatments on RA symptoms and condition for each
             individual patient
  
          -  What is the effectiveness of different treatments across all patients enrolled in the
             N-of-1 study
  
        Participants will be enrolled and randomized to a sequence of three U.S. Food and Drug
        Administration (FDA) approved RA medications: 1. adalimumab, 2. sarilumab, and 3.
        upadacitinib. Participants will be asked to complete questionnaires about their condition and
        quality of life weekly (either in clinic or remotely) and report their level of pain daily
        (remotely).
  Rheumatoid arthritis (RA) is a chronic, slowly progressive condition for which numerous
        treatment options are available. The therapies vary in mechanism of action, mode of
        administration, side- effect (adverse event) profile, and cost. While consensus treatment
        guidelines are available, identifying an optimal treatment sequence is often based on
        clinician choice with treatment changes based on tolerability and short- term outcome. The
        N-of-1 trial will evaluate individual participant and aggregate data.
  
        Individual participants will be enrolled and randomized to a sequence of three U.S. Food and
        Drug Administration (FDA)-approved therapeutic agents - adalimumab, sarilumab, upadacitinib-
        plus matching placebos to enable blinding of patients, clinicians, and study personnel.
  
        The N-of-1- RA protocol describes patient allocation into a series of individual randomized
        comparisons. These treatment conditions are double-blind and randomized, with inclusion of
        matching parallel placebo treatments identical in appearance to the active medications:
  
        • Patients with newly diagnosed rheumatoid arthritis following initial treatment with
        methotrexate (MTX). Prior to randomization, participants will be allocated to:
  
          -  MTX responder
  
          -  MTX non- responder
  
        Eligible participants will either continue MTX or discontinue MTX, based on response to
        initial therapy and tolerance. Participants identified for subsequent biologic therapy will
        enter the blinded biologic therapy phase of the study; with MTX either continued or not
        continued. This phase consists of a sequence of 3 therapeutic intervention regimens, each
        lasting 12-weeks. Each treatment period includes matching parallel placebo treatments
        identical to the active medications in appearance to ensure blinding of patients, clinicians,
        and study personnel.
  
        The treatment conditions are as follows:
  
        A. Tumor Necrosis Factor (TNF) Inhibitor biologic: Adalimumab 40 mg subcutaneously every 2
        weeks via subcutaneous injection with oral placebo once daily.
  
        B. Non-TNF-Inhibitor biologic: Sarilumab 200 mg via subcutaneous injection every 2 weeks with
        oral placebo once daily.
  
        C. Janus Kinase (JAK) Inhibitor: Upadacitinib 15 mg orally once daily with subcutaneous
        placebo injection every 2 weeks.
  
        Primary Objective (individual N-of-1 trial): To generate randomized evidence about the
        effects of therapeutic agents on RA symptoms and disease activity to inform decision about
        best treatment at the end of the trial period for each participant.
  
        Secondary Objective (aggregation of the series of N-of-1 trials): To evaluate the average
        relative effectiveness of therapeutic agents across all participants and explore
        heterogeneity of treatment effects.
  
        For the aggregated series of N-of-1 trial, we will use the following hierarchy of endpoints.
  
          -  Primary Endpoint:
  
          -  DAS28 (CRP)
  
          -  Secondary Endpoints including:
  
          -  American College of Rheumatology 20% (ACR20), 50% (ACR50) and 70% (ACR70) response
  
          -  Routine Assessment of Patient Index Data (RAPID3) score based on participants' report of
             overall assessment of the disease, the level of pain, and the amount of physical
             disability
  observational model: Other
  time perspective: Prospective
  measure: Change in Disease Activity Score (DAS) 28
  time frame: Baseline and at week 4, 8 and 12
  description: Evaluates patient and physician overall assessment of disease activity, including the number of swollen and painful joints (out of 28 joints),
  measure: Change in The Routine Assessment of Patient Index Data 3 (RAPID3)
  time frame: Baseline and at week 4, 6, 8, 10 and 12
  description: Assessment of a) function, b) pain, and c) patient global estimate of status
  measure: Change in American College of Rheumatology 20 (ACR20)
  time frame: Baseline and at week 4, 8 and 12
  description: ≥20% fewer tender and swollen joints and ≥20% improvement in three of five other domains; a) patient global assessment, b) physician global assessment, c) functional questionnaire, d) pain score, and f) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)
  measure: Change in American College of Rheumatology 50 (ACR50)
  time frame: Baseline and at week 4, 8 and 12
  description: ≥50% fewer tender and swollen joints and ≥20% improvement in three of five other domains; a) patient global assessment, b) physician global assessment, c) functional questionnaire, d) pain score, and f) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)
  measure: Change in American College of Rheumatology 70 (ACR70)
  time frame: Baseline and at week 4, 8 and 12
  description: ≥70% fewer tender and swollen joints and ≥20% improvement in three of five other domains; a) patient global assessment, b) physician global assessment, c) functional questionnaire, d) pain score, and f) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)
  measure: The Medical Outcome Study Short-Form 12- item Health Survey (SF-12)
  time frame: Baseline and at week 4, 6, 8, 10 and 12
  description: General Health Questionnaire
  measure: The Patient-Reported Measure of Physical Function (PROMIS) PF10a
  time frame: Baseline and at week 4, 6, 8, 10 and 12
  description: Patient self- assessment of function
  measure: Treatment Burden Questionnaire (TBQ)
  time frame: At End of Treatment
  description: Assessment of the burden associated with taking medicine, self-monitoring, laboratory tests, doctor visits, need for organization, administrative tasks, following advice on diet and physical activity, and social impact of treatment.
  intervention type: Drug
  intervention name: Adalimumab
  description: 40 mg subcutaneously every 2 weeks with oral placebo once daily
  other name: Humira
  intervention type: Drug
  intervention name: Sarilumab
  description: 200 mg subcutaneously every 2 weeks with oral placebo once daily
  other name: Kevzara
  intervention type: Drug
  intervention name: Upadacitinib
  description: 15 mg orally once daily with subcutaneous placebo injection every 2 weeks
  other name: Rinvoq
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Dorothy Dulko
  phone: 6176365009
  email: ddulko@tuftsmedicalcenter.org
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Arthritis
  mesh term: Arthritis, Rheumatoid
  mesh term: Adalimumab
  mesh term: Upadacitinib