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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

AbbVie

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.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis (RA)	Drug: Elsubrutinib Drug: Upadacitinib Drug: Placebo for elsubrutinib Drug: Placebo for upadacitinib	Phase 2

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 Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	242 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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
Actual Study Start Date :	October 8, 2018
Actual Primary Completion Date :	March 26, 2020
Actual Study Completion Date :	March 26, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rheumatoid arthritis

MedlinePlus related topics: Arthritis Rheumatoid Arthritis

Drug Information available for: Upadacitinib

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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	Drug: Placebo for elsubrutinib Placebo capsule for elsubrutinib will be administered orally. Drug: Placebo for upadacitinib Placebo tablet for upadacitinib will be administered orally.
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	Drug: Elsubrutinib Elsubrutinib capsule will be administered orally. Other Name: ABBV-105 Drug: Upadacitinib Upadacitinib tablet will be administered orally. Other Name: ABT-494
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	Drug: Elsubrutinib Elsubrutinib capsule will be administered orally. Other Name: ABBV-105 Drug: Placebo for upadacitinib Placebo tablet for upadacitinib will be administered orally.
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	Drug: Elsubrutinib Elsubrutinib capsule will be administered orally. Other Name: ABBV-105 Drug: Placebo for upadacitinib Placebo tablet for upadacitinib will be administered orally.
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	Drug: Elsubrutinib Elsubrutinib capsule will be administered orally. Other Name: ABBV-105 Drug: Placebo for upadacitinib Placebo tablet for upadacitinib will be administered orally.
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	Drug: Upadacitinib Upadacitinib tablet will be administered orally. Other Name: ABT-494 Drug: Placebo for elsubrutinib Placebo capsule for elsubrutinib will be administered orally.

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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).

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682705

Locations

Show 115 study locations

Layout table for location information

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

Sponsors and Collaborators

AbbVie

Investigators

Layout table for investigator information

Study Director:	AbbVie Inc.	AbbVie

Study Documents (Full-Text)

Documents provided by AbbVie:

Study Protocol [PDF] October 15, 2019

Statistical Analysis Plan [PDF] January 23, 2020

More Information

Layout table for additonal information

Responsible Party:	AbbVie
ClinicalTrials.gov Identifier:	NCT03682705
Other Study ID Numbers:	M16-063 2018-000666-10 ( EudraCT Number )
First Posted:	September 25, 2018 Key Record Dates
Results First Posted:	May 3, 2021
Last Update Posted:	May 3, 2021
Last Verified:	April 2021
Individual Participant Data (IPD) Sharing Statement:
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 Statistical Analysis Plan (SAP) 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

Layout table for additional information

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

Keywords provided by AbbVie:


Elsubrutinib ABBV-105 Upadacitinib ABBV-599 Rheumatoid Arthritis

Additional relevant MeSH terms:

Layout table for MeSH terms

Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases	Immune System Diseases Upadacitinib Janus Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents

To Top