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A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03682705
Recruitment Status : Completed
First Posted : September 25, 2018
Results First Posted : May 3, 2021
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE September 21, 2018
First Posted Date  ICMJE September 25, 2018
Results First Submitted Date  ICMJE March 4, 2021
Results First Posted Date  ICMJE May 3, 2021
Last Update Posted Date May 3, 2021
Actual Study Start Date  ICMJE October 8, 2018
Actual Primary Completion Date March 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2021)
Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12 [ Time Frame: Baseline, Week 12 ]
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
Change from baseline in Disease Activity Score (DAS) 28 (C-reactive protein [CRP]) [ Time Frame: At Week 12 ]
The DAS28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2021)
  • Change From Baseline in Clinical Disease Activity Index (CDAI) [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from baseline indicates improvement in disease activity.
  • Change From Baseline in Simplified Disease Activity Index (SDAI) [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm), global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (CRP; mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86.with higher scores indicating higher disease activity. A negative change from baseline indicates improvement in disease activity.
  • Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12 [ Time Frame: At Week 12 ]
    The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6.
  • Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12 [ Time Frame: At Week 12 ]
    The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Low Disease Activity (LDA) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than or equal to 3.2.
  • Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria [ Time Frame: Week 2, Week 4, Week 8, and Week 12 ]
    The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Low Disease Activity (LDA) based on CDAI is defined as achieving a CDAI of less than or equal to 10.
  • Percentage of Participants Achieving Complete Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria [ Time Frame: Week 2, Week 4, Week 8, and Week 12 ]
    The CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Complete Remission (CR) based on CDAI is defined as achieving a CDAI of less than or equal to 2.8.
  • Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 20% response (ACR20) criteria:
    1. ≥ 20% improvement in 68-tender joint count
    2. ≥ 20% improvement in 66-swollen joint count and
    3. ≥ 20% improvement in at least 3 of the 5 following parameters:
      • Patient's Assessment of Pain (Visual Analog Scale [VAS])
      • Patient's Global Assessment of Disease Activity (PtGA)
      • Physician's Global Assessment of Disease Activity (PhGA)
      • Health Assessment Questionnaire Disability Index (HAQ-DI)
      • High-sensitivity C-reactive protein (hsCRP)
  • Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 50% response (ACR50) criteria:
    1. ≥ 50% improvement in 68-tender joint count
    2. ≥ 50% improvement in 66-swollen joint count and
    3. ≥ 50% improvement in at least 3 of the 5 following parameters:
      • Patient's Assessment of Pain (Visual Analog Scale [VAS])
      • Patient's Global Assessment of Disease Activity (PtGA)
      • Physician's Global Assessment of Disease Activity (PhGA)
      • Health Assessment Questionnaire Disability Index (HAQ-DI)
      • High-sensitivity C-reactive protein (hsCRP)
  • Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 70% response (ACR70) criteria:
    1. ≥ 70% improvement in 68-tender joint count
    2. ≥ 70% improvement in 66-swollen joint count and
    3. ≥ 70% improvement in at least 3 of the 5 following parameters:
      • Patient's Assessment of Pain (Visual Analog Scale [VAS])
      • Patient's Global Assessment of Disease Activity (PtGA)
      • Physician's Global Assessment of Disease Activity (PhGA)
      • Health Assessment Questionnaire Disability Index (HAQ-DI)
      • High-sensitivity C-reactive protein (hsCRP)
  • Change From Baseline in Tender Joint Count 68 (TJC68) [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    Sixty-eight joints were assessed for tenderness by physical examination. Pain or tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 68 (worst possible score/68 joints with tenderness). Negative values indicate improvement from baseline.
  • Change From Baseline in Swollen Joint Count 66 (SJC66) [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    Sixty-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 66 (worst possible score/66 joints with swelling). Negative values indicate improvement from baseline.
  • Change From Baseline in Participant's Assessment of Pain (Visual Analog Scale [VAS]) [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    Participants rated their pain on a visual analogue scale (VAS) of 0 to 100 (mm), with 0 representing no pain and 100 representing the worst possible pain. Negative values indicate improvement from baseline.
  • Change From Baseline in Patient's Global Assessment of Disease Activity (PGA) [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.
  • Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA) [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    The physician assessed a participant's disease activity at the time of the visit using a Physician's Global Assessment of Disease visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline.
  • Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from baseline in the overall score indicates improvement.
  • Change From Baseline in High-Sensitivity C-reactive Protein (hsCRP) [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    C-reactive protein is a blood test marker for inflammation in the body, and levels rise in response to inflammation. A negative change from baseline in indicates improvement.
  • Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.
  • Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28- ESR) [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    The DAS28-ESR is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hour), and the participant's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 100 mm) are included in the DAS28 -ESR score. Scores on the DAS28-ESR range from 0 to 10; higher scores indicate more disease activity.
  • Change From Baseline in Morning Stiffness Severity [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    Morning stiffness severity was assessed by a numeric rating-scale (NRS). Participants rated the severity of morning stiffness during the past week from 0 to 10 with 0 representing "not severe" and 10 "very severe". Negative values indicate improvement from baseline.
  • Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. The minimal clinically important difference (MCID) in HAQ-DI is defined as change from Baseline ≤ -0.22 for rheumatoid arthritis.
  • Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (EULAR) Boolean Remission [ Time Frame: Baseline, Week 2, Week 4, Week 8, and Week 12 ]
    The EULAR Boolean-based definition of remission is as follows: at any time point, a participant must satisfy all of the following: tender joint count ≤1, swollen joint count ≤1, C-reactive protein ≤1 mg/dl and Patient Global Assessment (PGA) ≤1 (on a 0-10 scale).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
  • Change from baseline in Clinical Disease Activity Index (CDAI) [ Time Frame: Up to Week 12 ]
    The CDAI is validated measure of RA disease activity.
  • Change from baseline in Simplified Disease Activity Index (SDAI) [ Time Frame: Up to Week 12 ]
    SDAI is validated measure of RA disease activity.
  • Proportion of participants achieving Clinical Remission (CR) [ Time Frame: At Week 12 ]
    Clinical Remission is defined as DAS28 CRP <2.6
  • Proportion of participants achieving Low Disease Activity (LDA) [ Time Frame: At Week 12 ]
    LDA is defined as DAS28 CRP<=3.2
  • American College of Rheumatology (ACR)20 response rate [ Time Frame: Up to Week 12 ]
    ACR 20 response rate will be determined based on 20%or greater improvement in Tender Joint Count (TJC) and Swollen Joint Count (SJC) and ≥ 3 of the 5 measures of Patient's Assessment of Pain (Visual Analog Scale [VAS]), Patient's Global Assessment of Disease Activity (PtGA), Physician's Global Assessment of Disease Activity (PhGA), Health Assessment Questionnaire Disability Index (HAQ-DI), or high-sensitivity C-reactive protein (hsCRP).
  • ACR 50 response rate [ Time Frame: Up to Week 12 ]
    ACR 50 response rate will be determined based on 50% or greater improvement in Tender Joint Count (TJC) and Swollen Joint Count (SJC) and ≥ 3 of the 5 measures of Patient's Assessment of Pain (Visual Analog Scale (VAS)), Patient's Global Assessment of Disease Activity (PtGA), Physician's Global Assessment of Disease Activity (PhGA), Health Assessment Questionnaire Disability Index (HAQ-DI), or high-sensitivity C-reactive protein (hsCRP).
  • ACR 70 response rate [ Time Frame: Up to Week 12 ]
    ACR 70 response rate will be determined based on 70% or greater improvement in Tender Joint Count (TJC) and Swollen Joint Count (SJC) and ≥ 3 of the 5 measures of Patient's Assessment of Pain (Visual Analog Scale (VAS)), Patient's Global Assessment of Disease Activity (PtGA), Physician's Global Assessment of Disease Activity (PhGA), Health Assessment Questionnaire Disability Index (HAQ-DI), or high-sensitivity C-reactive protein (hsCRP).
  • Change from baseline in individual components of ACR response [ Time Frame: Up to Week 12 ]
    ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.
  • Change from baseline in DAS28(CRP) [ Time Frame: Up to Week 12 ]
    The Disease Activity Score (DAS)28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 to 10.
  • Change from baseline in DAS28 (Erythrocyte Sedimentation Rate (ESR)) [ Time Frame: Up to Week 12 ]
    The change in the Disease Activity Score (DAS)28 (erythrocyte sedimentation rate) from the baseline is assessed.
  • Change from baseline in morning stiffness [ Time Frame: Up to Week 12 ]
    Duration of morning stiffness on numeric rating scale (from 0 to 10) will be assessed.
  • Change from baseline in HAQ-DI [ Time Frame: Up to Week 12 ]
    The HAQ DI is a patient-reported questionnaire. It includes the categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. It asks patients about the amount of difficulty they experience in these activities as well as the use of aids and/or devices.
  • Proportion of participants achieving Minimal Clinically Important Difference (MCID) in change from baseline in HAQ-DI [ Time Frame: Up to Week 12 ]
    It is defined as change from baseline in HAQ-DI ≤ -0.3
  • Proportion of participants achieving ACR remission [ Time Frame: Up to Week 12 ]
    ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.
  • Proportion of participants achieving European League Against Rheumatism (EULAR) Boolean remission [ Time Frame: Up to Week 12 ]
    A EULAR remission reflects improvement in disease activity and attainment of a lower degree of disease activity.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis
Official Title  ICMJE Rheumatoid Arthritis: A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599 Combination) With a Background of Conventional Synthetic DMARDs in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs
Brief Summary This was a phase 2 study to evaluate the safety and efficacy of elsubrutinib (ELS) and ABBV-599 (ELS plus upadacitinib [UPA]) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs (bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.
Detailed Description This was a 12-week, randomized, double-blind, parallel-group, Phase 2, dose exploratory, multicenter study. Participants who met eligibility criteria were randomized in a 3:2:2:2:2:1 ratio to 1 of 6 treatment groups: ABBV-599 [UPA 15 mg/ELS 60 mg]); ELS 60 mg/UPA placebo; ELS 20 mg/UPA placebo; ELS 5 mg/UPA placebo; UPA 15 mg/ELS placebo; and ELS placebo/UPA placebo. The study included a 35-day maximum screening period and a 12-week treatment period with 30-day follow-up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis (RA)
Intervention  ICMJE
  • Drug: Elsubrutinib
    Elsubrutinib capsule will be administered orally.
    Other Name: ABBV-105
  • Drug: Upadacitinib
    Upadacitinib tablet will be administered orally.
    Other Name: ABT-494
  • Drug: Placebo for elsubrutinib
    Placebo capsule for elsubrutinib will be administered orally.
  • Drug: Placebo for upadacitinib
    Placebo tablet for upadacitinib will be administered orally.
Study Arms  ICMJE
  • Placebo Comparator: ELS placebo/UPA placebo
    Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
    Interventions:
    • Drug: Placebo for elsubrutinib
    • Drug: Placebo for upadacitinib
  • Experimental: UPA 15 mg/ELS 60 mg
    15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks
    Interventions:
    • Drug: Elsubrutinib
    • Drug: Upadacitinib
  • Experimental: ELS 60 mg/UPA placebo
    60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
    Interventions:
    • Drug: Elsubrutinib
    • Drug: Placebo for upadacitinib
  • Experimental: ELS 20 mg/UPA placebo
    20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
    Interventions:
    • Drug: Elsubrutinib
    • Drug: Placebo for upadacitinib
  • Experimental: ELS 5 mg/UPA placebo
    5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks
    Interventions:
    • Drug: Elsubrutinib
    • Drug: Placebo for upadacitinib
  • Experimental: UPA 15 mg/ELS placebo
    15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks
    Interventions:
    • Drug: Upadacitinib
    • Drug: Placebo for elsubrutinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2019)
242
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2018)
240
Actual Study Completion Date  ICMJE March 26, 2020
Actual Primary Completion Date March 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months based on the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA
  • Participant meets the following minimum disease activity criteria:

    • ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits
    • High-sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L (central lab) at Screening Visit
  • Participants must have been treated for ≥ 3 months with ≥ 1 biologic disease-modifying anti-rheumatic drug (bDMARD) therapy but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration
  • Participants must have been receiving conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug
  • Participants must have discontinued all bDMARDs prior to the first dose of study drug

Exclusion Criteria:

- Participant has prior exposure to any Janus Kinase (JAK) inhibitor for greater than 2 weeks (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib). A washout period of ≥ 30 days is required for any JAK inhibitor prior to the first dose of study drug.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czechia,   Hungary,   Poland,   Puerto Rico,   Spain,   United Kingdom,   United States
Removed Location Countries Germany,   Ireland
 
Administrative Information
NCT Number  ICMJE NCT03682705
Other Study ID Numbers  ICMJE M16-063
2018-000666-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP