A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs
Public ClinicalTrials.gov record NCT03086343. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Active-Controlled, Double-Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study objective of Period 1 was to compare the safety and efficacy of upadacitinib 15 mg once daily (QD) to abatacept on a background of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in biologic disease-modifying antirheumatic drug (bDMARD)-inadequate response or bDMARD-intolerant participants with moderately to severely active RA. The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD in participants with RA who had completed Period 1.
Study identification
- NCT ID
- NCT03086343
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 657 participants
Conditions and interventions
Conditions
Interventions
- Abatacept Drug
- Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion) Drug
- Upadacitinib Drug
- Placebo for upadacitinib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 9, 2017 (Actual)
- Primary completion
- Jun 13, 2019 (Actual)
- Completion
- Jun 6, 2023 (Actual)
- Last update posted
- Jul 18, 2024
2017 – 2023
United States locations
- U.S. sites
- 44
- U.S. states
- 22
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SunValley Arthritis Center, Lt /ID# 154558 | Peoria | Arizona | 85381 | — |
| AZ Arthritis & Rheum Research /ID# 156539 | Sun City | Arizona | 85351 | — |
| AZ Arth & Rheum Res /ID# 167161 | Tucson | Arizona | 85704 | — |
| CHI St. Vincent Medical Group /ID# 154561 | Hot Springs | Arkansas | 71913-6999 | — |
| Saint Jude Heritage /ID# 158833 | Fullerton | California | 92835 | — |
| Kotha and Kotha /ID# 154573 | La Mesa | California | 91942 | — |
| Denver Arthritis Clinic /ID# 159195 | Denver | Colorado | 80230 | — |
| Arthritis and Rheum Clin N. CO /ID# 155673 | Fort Collins | Colorado | 80528 | — |
| Scientia Medical Research /ID# 159189 | Lakewood | Colorado | 80228 | — |
| Clinical Res of West FL, Inc. /ID# 154576 | Clearwater | Florida | 33765 | — |
| Advanced Clin Res of Orlando /ID# 154580 | Ocoee | Florida | 34761-4547 | — |
| Gulf Region Clinical Res Inst /ID# 154597 | Pensacola | Florida | 32514 | — |
| W. Broward Rheum Assoc Inc. /ID# 158835 | Tamarac | Florida | 33321 | — |
| Lovelace Scientific Resources /ID# 154600 | Venice | Florida | 34292 | — |
| Jefrey D. Lieberman, MD, P.C. /ID# 157178 | Decatur | Georgia | 30033 | — |
| Advanced Clinical Research /ID# 154603 | Meridian | Idaho | 83642 | — |
| PMG Research of Christie Clini /ID# 154569 | Champaign | Illinois | 61820 | — |
| Bluegrass Community Research /ID# 154604 | Lexington | Kentucky | 40515 | — |
| Four Rivers Clinical Research /ID# 154606 | Paducah | Kentucky | 42003 | — |
| Ochsner Clinic Foundation /ID# 154585 | Baton Rouge | Louisiana | 70836-6455 | — |
| The Center for Rheumatology & Bone Research /ID# 158723 | Wheaton | Maryland | 20902 | — |
| West Michigan Rheumatology /ID# 154551 | Grand Rapids | Michigan | 49546 | — |
| Advanced Rheumatology, PC /ID# 154589 | Lansing | Michigan | 48910 | — |
| Clinvest Research LLC /ID# 154554 | Springfield | Missouri | 65810-2607 | — |
| Overlook Medical Center /ID# 154794 | Summit | New Jersey | 07901-3561 | — |
| Atlantic Coast Research /ID# 155234 | Toms River | New Jersey | 08755 | — |
| Ocean Rheumatology, PA /ID# 162980 | Toms River | New Jersey | 08755 | — |
| Arthritis and Osteo Assoc /ID# 154560 | Las Cruces | New Mexico | 88011 | — |
| The Center for Rheumatology /ID# 162979 | Albany | New York | 12206 | — |
| NYU Langone Rheum Assoc /ID# 155236 | Lake Success | New York | 11554 | — |
| NYU Langone Medical Center /ID# 158829 | New York | New York | 10016-6402 | — |
| Physicians East, PA /ID# 154565 | Greenville | North Carolina | 27834 | — |
| PMG Research of Salisbury /ID# 154605 | Salisbury | North Carolina | 28144 | — |
| PMG Research of Wilmington LLC /ID# 154584 | Wilmington | North Carolina | 28401 | — |
| Wake Forest Baptist Medical Center /ID# 154586 | Winston-Salem | North Carolina | 27157-0001 | — |
| Oregon Health and Science University /ID# 163822 | Portland | Oregon | 97239 | — |
| East Penn Rheumatology Assoc /ID# 159193 | Bethlehem | Pennsylvania | 18015 | — |
| Altoona Ctr Clinical Res /ID# 154572 | Duncansville | Pennsylvania | 16635 | — |
| University of Pittsburgh MC /ID# 157434 | Pittsburgh | Pennsylvania | 15260 | — |
| West Tennessee Research Inst /ID# 158721 | Jackson | Tennessee | 38305 | — |
| Adriana Pop-Moody MD Clinic PA /ID# 154607 | Corpus Christi | Texas | 78404 | — |
| P&I Clinical Research /ID# 159191 | Lufkin | Texas | 75904-3132 | — |
| DM Clinical Research /ID# 158722 | Tomball | Texas | 77375 | — |
| Care Access Research /ID# 158098 | Salt Lake City | Utah | 84124-1377 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 117 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03086343, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 18, 2024 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03086343 live on ClinicalTrials.gov.