search
Back to results

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

Primary Purpose

Rheumatoid Arthritis (RA)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Elsubrutinib
Upadacitinib
Placebo for elsubrutinib
Placebo for upadacitinib
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis (RA) focused on measuring Elsubrutinib, ABBV-105, Upadacitinib, ABBV-599, Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rheum Assoc of North Alabama /ID# 167382
  • AZ Arthritis & Rheum Research /ID# 167446
  • SunValley Arthritis Center, Lt /ID# 213073
  • AZ Arthritis and Rheum Researc /ID# 167448
  • St. Joseph Heritage Healthcare /ID# 167379
  • Purushotham, Akther & Roshan K /ID# 168121
  • Valerius Medical Group /ID# 168123
  • Sierra Rheumatology /ID# 167976
  • Rheumatology Center of San Diego /ID# 170690
  • Iraj Sabahi Research, Inc /ID# 201923
  • Inland Rheum Clin Trials Inc. /ID# 167459
  • Medvin Clinical Research /ID# 205731
  • Rheumatology Consultants of De /ID# 208238
  • Bay Area Arthritis and Osteo /ID# 208111
  • Clinical Res of West FL, Inc. /ID# 167462
  • Omega Research Maitland, LLC /ID# 167376
  • Riverside Clinical Research /ID# 167982
  • Lakes Research, LLC /ID# 170660
  • Kendall South Medical Center, Inc. /ID# 206857
  • Medallion Clinical Research Institute, LLC /ID# 201710
  • Rheum Assoc of Central FL /ID# 170858
  • HMD Research LLC /ID# 208381
  • International Medical Research - Ormond /ID# 170864
  • Millennium Research /ID# 167453
  • Arthritis Center, Inc. /ID# 170695
  • Integral Rheumatology & Immunology Specialists /ID# 206724
  • BayCare Medical Group /ID# 170860
  • St. Anthony Comprehensive Rese /ID# 170668
  • Clinical Research of West Florida, Inc /ID# 169099
  • ForCare Clinical Research /ID# 206280
  • Florida Medical Clinic /ID# 206279
  • Institute of Arthritis Researc /ID# 170694
  • Great Lakes Clinical Trials /ID# 167471
  • Clinical Investigation Specialists - Skokie /ID# 167468
  • Deerbrook Medical Associates /ID# 207098
  • PRN of Kansas /ID# 167985
  • The Arthritis & Diabetes Clinic, Inc. /ID# 170682
  • Mansfield Health Center /ID# 167372
  • Advanced Clinical Care /ID# 167367
  • June DO, PC /ID# 170670
  • Beals Instititute /ID# 170658
  • Arthritis Associates /ID# 209075
  • North Mississippi Med Clinics /ID# 167377
  • Clayton Medical Associates dba Saint Louis Rheumatology /ID# 170650
  • Physician Research Collaboration, LLC /ID# 200480
  • Dhmc /Id# 167476
  • Ocean Rheumatology /ID# 170673
  • Arthritis and Osteo Assoc /ID# 167443
  • DJL Clinical Research, PLLC /ID# 167374
  • EmergeOrtho, P.A. /ID# 209154
  • Cape Fear Arthritis Care /ID# 167413
  • New Horizons Clinical Research /ID# 170862
  • Marietta Memorial Hospital /ID# 210968
  • STAT Research, Inc. /ID# 200485
  • Health Research of Oklahoma /ID# 167370
  • Clinical Research Ctr Reading /ID# 170708
  • West Tennessee Research Inst /ID# 167366
  • Nashville Arthritis and Rheumatology /ID# 206699
  • Amarillo Ctr for Clin Research /ID# 200484
  • Tekton Research, Inc. /ID# 167475
  • Trinity Universal Res Assoc /ID# 209252
  • Arth and Osteo Clin Brazo Valley /ID# 209401
  • Metroplex Clinical Research /ID# 167458
  • Rheumatic Disease Clin Res Ctr /ID# 167474
  • Rheumatology Clinic of Houston /ID# 203689
  • Accurate Clinical Research /ID# 207059
  • West Texas Clinical Research /ID# 205732
  • SW Rheumatology Res. LLC /ID# 167383
  • Trinity Universal Research Association /ID# 209253
  • Sun Research Institute /ID# 170667
  • Accurate Clinical Management /ID# 200481
  • DM Clinical Research /ID# 167444
  • Arthritis & Osteoporosis Clinic /ID# 167407
  • Tidewater Physicians Medical Center /ID# 210884
  • Western Washington Arthritis C /ID# 205821
  • Arthritis Northwest, PLLC /ID# 200479
  • Rheumatology and Pulmonary cli /ID# 170863
  • Aurora Rheumatology and Immunotherapy Center /ID# 167385
  • CUB Hospital Erasme /ID# 201965
  • Cliniques Universitaires Saint Luc /ID# 201756
  • UZ Ghent /ID# 201757
  • UZ Leuven /ID# 201927
  • Rheumatology Research Assoc /ID# 207299
  • Manitoba Clinic /ID# 202126
  • CIADS Research Co Ltd /ID# 202125
  • Credit Valley Rheumatology /ID# 202124
  • Mount Sinai Hosp.-Toronto /ID# 202652
  • Dr. Latha Naik /ID# 212972
  • Revmatolog s.r.o. /ID# 202610
  • Revmatologicky ustav Praha /ID# 202142
  • Revmatologie MUDr. Klara Sirova /ID# 205185
  • CCR Czech a.s /ID# 202144
  • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 202439
  • Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatokorhaz /ID# 202441
  • Revita Reumatologiai Rendelo /ID# 202438
  • CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 205804
  • Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 202437
  • Malopolskie Centrum Kliniczne /ID# 206473
  • McBk Sc /Id# 212575
  • NBR Polska /ID# 206476
  • ClinicMed Daniluk, Nowak Sp.j. /ID# 212576
  • Reumatika - Centrum Reumatologii NZOZ /ID# 206472
  • GCM Medical Group, PSC /ID# 167983
  • Hospital Universitario A Coruña - CHUAC /ID# 202140
  • Hospital Unversitario Marques de Valdecilla /ID# 202133
  • Hospital Regional de Malaga /ID# 202137
  • Hospital Clinic /ID# 206575
  • Hospital Santa Creu i Sant Pau /ID# 206535
  • Hospital Universitario Basurto /ID# 206462
  • Hospital Universitario Virgen de las Nieves /ID# 209705
  • Hospital Clinico Universitario San Carlos /ID# 202135
  • Hospital Universitario y Politecnico La Fe /ID# 202139
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 201976
  • University of Oxford /ID# 201974
  • Warrington and Halton Teaching Hosp NHS Foundation Trust /ID# 206002

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

ELS placebo/UPA placebo

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

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) 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. A negative change from baseline indicates improvement in disease activity.

Secondary Outcome Measures

Change From Baseline in Clinical Disease Activity Index (CDAI)
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)
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
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
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
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
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
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 20% response (ACR20) criteria: ≥ 20% improvement in 68-tender joint count ≥ 20% improvement in 66-swollen joint count and ≥ 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
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 50% response (ACR50) criteria: ≥ 50% improvement in 68-tender joint count ≥ 50% improvement in 66-swollen joint count and ≥ 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
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 70% response (ACR70) criteria: ≥ 70% improvement in 68-tender joint count ≥ 70% improvement in 66-swollen joint count and ≥ 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)
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)
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])
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)
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)
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)
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)
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])
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)
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
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)
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
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).

Full Information

First Posted
September 21, 2018
Last Updated
April 6, 2021
Sponsor
AbbVie
search

1. Study Identification

Unique Protocol Identification Number
NCT03682705
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
March 26, 2020 (Actual)
Study Completion Date
March 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis (RA)
Keywords
Elsubrutinib, ABBV-105, Upadacitinib, ABBV-599, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ELS placebo/UPA placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
UPA 15 mg/ELS 60 mg
Arm Type
Experimental
Arm Description
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
Arm Title
ELS 60 mg/UPA placebo
Arm Type
Experimental
Arm Description
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
Arm Title
ELS 20 mg/UPA placebo
Arm Type
Experimental
Arm Description
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
Arm Title
ELS 5 mg/UPA placebo
Arm Type
Experimental
Arm Description
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
Arm Title
UPA 15 mg/ELS placebo
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Elsubrutinib
Other Intervention Name(s)
ABBV-105
Intervention Description
Elsubrutinib capsule will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494
Intervention Description
Upadacitinib tablet will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo for elsubrutinib
Intervention Description
Placebo capsule for elsubrutinib will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo for upadacitinib
Intervention Description
Placebo tablet for upadacitinib will be administered orally.
Primary Outcome Measure Information:
Title
Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Clinical Disease Activity Index (CDAI)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Change From Baseline in Simplified Disease Activity Index (SDAI)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12
Description
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.
Time Frame
At Week 12
Title
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12
Description
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.
Time Frame
At Week 12
Title
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
Description
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.
Time Frame
Week 2, Week 4, Week 8, and Week 12
Title
Percentage of Participants Achieving Complete Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria
Description
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.
Time Frame
Week 2, Week 4, Week 8, and Week 12
Title
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Description
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 20% response (ACR20) criteria: ≥ 20% improvement in 68-tender joint count ≥ 20% improvement in 66-swollen joint count and ≥ 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)
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Description
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 50% response (ACR50) criteria: ≥ 50% improvement in 68-tender joint count ≥ 50% improvement in 66-swollen joint count and ≥ 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)
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Description
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the American College of Rheumatology 70% response (ACR70) criteria: ≥ 70% improvement in 68-tender joint count ≥ 70% improvement in 66-swollen joint count and ≥ 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)
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Change From Baseline in Tender Joint Count 68 (TJC68)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Change From Baseline in Swollen Joint Count 66 (SJC66)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Change From Baseline in Participant's Assessment of Pain (Visual Analog Scale [VAS])
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Change From Baseline in Patient's Global Assessment of Disease Activity (PGA)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Change From Baseline in High-Sensitivity C-reactive Protein (hsCRP)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP])
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28- ESR)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Change From Baseline in Morning Stiffness Severity
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Description
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.
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12
Title
Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (EULAR) Boolean Remission
Description
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).
Time Frame
Baseline, Week 2, Week 4, Week 8, and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Rheum Assoc of North Alabama /ID# 167382
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
AZ Arthritis & Rheum Research /ID# 167446
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
SunValley Arthritis Center, Lt /ID# 213073
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
AZ Arthritis and Rheum Researc /ID# 167448
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
St. Joseph Heritage Healthcare /ID# 167379
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Purushotham, Akther & Roshan K /ID# 168121
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Valerius Medical Group /ID# 168123
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Sierra Rheumatology /ID# 167976
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Rheumatology Center of San Diego /ID# 170690
City
San Diego
State/Province
California
ZIP/Postal Code
92128-2549
Country
United States
Facility Name
Iraj Sabahi Research, Inc /ID# 201923
City
Turlock
State/Province
California
ZIP/Postal Code
95382-2007
Country
United States
Facility Name
Inland Rheum Clin Trials Inc. /ID# 167459
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Medvin Clinical Research /ID# 205731
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
Rheumatology Consultants of De /ID# 208238
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Bay Area Arthritis and Osteo /ID# 208111
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Clinical Res of West FL, Inc. /ID# 167462
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Omega Research Maitland, LLC /ID# 167376
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713-2260
Country
United States
Facility Name
Riverside Clinical Research /ID# 167982
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Lakes Research, LLC /ID# 170660
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Kendall South Medical Center, Inc. /ID# 206857
City
Miami
State/Province
Florida
ZIP/Postal Code
33185-5948
Country
United States
Facility Name
Medallion Clinical Research Institute, LLC /ID# 201710
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Rheum Assoc of Central FL /ID# 170858
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
HMD Research LLC /ID# 208381
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
International Medical Research - Ormond /ID# 170864
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Millennium Research /ID# 167453
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Arthritis Center, Inc. /ID# 170695
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Integral Rheumatology & Immunology Specialists /ID# 206724
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
BayCare Medical Group /ID# 170860
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
St. Anthony Comprehensive Rese /ID# 170668
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Clinical Research of West Florida, Inc /ID# 169099
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606-1246
Country
United States
Facility Name
ForCare Clinical Research /ID# 206280
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
Florida Medical Clinic /ID# 206279
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Institute of Arthritis Researc /ID# 170694
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Great Lakes Clinical Trials /ID# 167471
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Clinical Investigation Specialists - Skokie /ID# 167468
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Deerbrook Medical Associates /ID# 207098
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
PRN of Kansas /ID# 167985
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
The Arthritis & Diabetes Clinic, Inc. /ID# 170682
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Mansfield Health Center /ID# 167372
City
Mansfield
State/Province
Massachusetts
ZIP/Postal Code
02048
Country
United States
Facility Name
Advanced Clinical Care /ID# 167367
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
June DO, PC /ID# 170670
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Beals Instititute /ID# 170658
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48917
Country
United States
Facility Name
Arthritis Associates /ID# 209075
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States
Facility Name
North Mississippi Med Clinics /ID# 167377
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Clayton Medical Associates dba Saint Louis Rheumatology /ID# 170650
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63119-3845
Country
United States
Facility Name
Physician Research Collaboration, LLC /ID# 200480
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Dhmc /Id# 167476
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Ocean Rheumatology /ID# 170673
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Arthritis and Osteo Assoc /ID# 167443
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
DJL Clinical Research, PLLC /ID# 167374
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210-8508
Country
United States
Facility Name
EmergeOrtho, P.A. /ID# 209154
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Cape Fear Arthritis Care /ID# 167413
City
Leland
State/Province
North Carolina
ZIP/Postal Code
28451
Country
United States
Facility Name
New Horizons Clinical Research /ID# 170862
City
Blue Ash
State/Province
Ohio
ZIP/Postal Code
45242-3763
Country
United States
Facility Name
Marietta Memorial Hospital /ID# 210968
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750-1635
Country
United States
Facility Name
STAT Research, Inc. /ID# 200485
City
Vandalia
State/Province
Ohio
ZIP/Postal Code
45377-9464
Country
United States
Facility Name
Health Research of Oklahoma /ID# 167370
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103-2400
Country
United States
Facility Name
Clinical Research Ctr Reading /ID# 170708
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
West Tennessee Research Inst /ID# 167366
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Nashville Arthritis and Rheumatology /ID# 206699
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Amarillo Ctr for Clin Research /ID# 200484
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Tekton Research, Inc. /ID# 167475
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Trinity Universal Res Assoc /ID# 209252
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Arth and Osteo Clin Brazo Valley /ID# 209401
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Metroplex Clinical Research /ID# 167458
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Rheumatic Disease Clin Res Ctr /ID# 167474
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Rheumatology Clinic of Houston /ID# 203689
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Accurate Clinical Research /ID# 207059
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
West Texas Clinical Research /ID# 205732
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410-1198
Country
United States
Facility Name
SW Rheumatology Res. LLC /ID# 167383
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Trinity Universal Research Association /ID# 209253
City
Plano
State/Province
Texas
ZIP/Postal Code
75024-5283
Country
United States
Facility Name
Sun Research Institute /ID# 170667
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Accurate Clinical Management /ID# 200481
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DM Clinical Research /ID# 167444
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Arthritis & Osteoporosis Clinic /ID# 167407
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Tidewater Physicians Medical Center /ID# 210884
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606-4434
Country
United States
Facility Name
Western Washington Arthritis C /ID# 205821
City
Bothell
State/Province
Washington
ZIP/Postal Code
98021
Country
United States
Facility Name
Arthritis Northwest, PLLC /ID# 200479
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Rheumatology and Pulmonary cli /ID# 170863
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Facility Name
Aurora Rheumatology and Immunotherapy Center /ID# 167385
City
Franklin
State/Province
Wisconsin
ZIP/Postal Code
53132
Country
United States
Facility Name
CUB Hospital Erasme /ID# 201965
City
Brussels
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques Universitaires Saint Luc /ID# 201756
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Ghent /ID# 201757
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven /ID# 201927
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Rheumatology Research Assoc /ID# 207299
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5M 0H4
Country
Canada
Facility Name
Manitoba Clinic /ID# 202126
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
CIADS Research Co Ltd /ID# 202125
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3N 0K6
Country
Canada
Facility Name
Credit Valley Rheumatology /ID# 202124
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
Mount Sinai Hosp.-Toronto /ID# 202652
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Dr. Latha Naik /ID# 212972
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 3H3
Country
Canada
Facility Name
Revmatolog s.r.o. /ID# 202610
City
Jihlava 1
State/Province
Jihlava
ZIP/Postal Code
586 01
Country
Czechia
Facility Name
Revmatologicky ustav Praha /ID# 202142
City
Prague 2
State/Province
Praha 2
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
Revmatologie MUDr. Klara Sirova /ID# 205185
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
CCR Czech a.s /ID# 202144
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 202439
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatokorhaz /ID# 202441
City
Nyíregyháza
State/Province
Szabolcs-Szatmar-Bereg
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Revita Reumatologiai Rendelo /ID# 202438
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 205804
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 202437
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Malopolskie Centrum Kliniczne /ID# 206473
City
Cracow
State/Province
Malopolskie
ZIP/Postal Code
30-149
Country
Poland
Facility Name
McBk Sc /Id# 212575
City
Grodzisk Mazowiecki
State/Province
Mazowieckie
ZIP/Postal Code
05-825
Country
Poland
Facility Name
NBR Polska /ID# 206476
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-465
Country
Poland
Facility Name
ClinicMed Daniluk, Nowak Sp.j. /ID# 212576
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Reumatika - Centrum Reumatologii NZOZ /ID# 206472
City
Warsaw
ZIP/Postal Code
02-691
Country
Poland
Facility Name
GCM Medical Group, PSC /ID# 167983
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Hospital Universitario A Coruña - CHUAC /ID# 202140
City
A Coruña
State/Province
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Unversitario Marques de Valdecilla /ID# 202133
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Regional de Malaga /ID# 202137
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clinic /ID# 206575
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau /ID# 206535
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Basurto /ID# 206462
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves /ID# 209705
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos /ID# 202135
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 202139
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 201976
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
University of Oxford /ID# 201974
City
Oxford
ZIP/Postal Code
OX3 7LF
Country
United Kingdom
Facility Name
Warrington and Halton Teaching Hosp NHS Foundation Trust /ID# 206002
City
Warrington
ZIP/Postal Code
WA5 1LZ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing 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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Learn more about this trial

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

We'll reach out to this number within 24 hrs