Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT05814627. 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 3b/4 Randomized, Double-Blind, Double Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and Who Had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT05814627
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 487 participants
Conditions and interventions
Conditions
Interventions
- Upadacitinib Drug
- Adalimumab Drug
- Upadacitinib Matching Placebo Drug
- Adalimumab Matching Placebo 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
- Jun 15, 2023 (Actual)
- Primary completion
- Jul 15, 2026 (Actual)
- Completion
- Jul 15, 2026 (Actual)
- Last update posted
- Aug 14, 2026
2023 – 2026
United States locations
- U.S. sites
- 85
- U.S. states
- 30
- U.S. cities
- 78
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 253431 | Flagstaff | Arizona | 86001-6299 | — |
| Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 255018 | Glendale | Arizona | 85306-9802 | — |
| Sun Valley Arthritis Center Ltd. /ID# 254654 | Peoria | Arizona | 85381 | — |
| Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 253432 | Phoenix | Arizona | 85032 | — |
| Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 255021 | Phoenix | Arizona | 85032 | — |
| Arizona Arthritis & Rheumatology Associates - Tucson /ID# 255017 | Tucson | Arizona | 85704 | — |
| Arthritis and Rheumatism Associates /ID# 254013 | Jonesboro | Arkansas | 72401-6251 | — |
| Providence - St. Jude Medical Center /ID# 252690 | Fullerton | California | 92835 | — |
| Newport Huntington Medical Group /ID# 252687 | Huntington Beach | California | 92648-5994 | — |
| Purushotham & Akther Kotha MD, Inc /ID# 252704 | La Mesa | California | 91942 | — |
| Valerius Medical Group & Research Center of Greater Long Beach, Inc /ID# 252692 | Los Alamitos | California | 90720-5402 | — |
| Rheumatology Center of San Diego /ID# 255038 | San Diego | California | 92128-2549 | — |
| Millennium Clinical Trials /ID# 252689 | Thousand Oaks | California | 91360-3951 | — |
| The Lundquist Institute at Harbor-UCLA Medical Center /ID# 252691 | Torrance | California | 90502 | — |
| Comprehensive Rheumatology Center /ID# 252688 | Woodland Hills | California | 91364 | — |
| University of Colorado Hospital /ID# 254617 | Aurora | Colorado | 80045 | — |
| Denver Arthritis Clinic /ID# 254058 | Denver | Colorado | 80230 | — |
| Tekton Research - Fort Collins - East Harmony Road /ID# 255036 | Fort Collins | Colorado | 80528 | — |
| Arthritis and Rheumatic Disease Specialties /ID# 260583 | Aventura | Florida | 33180 | — |
| Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253733 | Boca Raton | Florida | 33486 | — |
| Bay Area Arthritis and Osteo /ID# 254046 | Brandon | Florida | 33511 | — |
| Believe Clinical Trial /ID# 262355 | Coral Springs | Florida | 33065 | — |
| International Medical Research /ID# 254651 | Daytona Beach | Florida | 32117 | — |
| Omega Research Debary, LLC /ID# 253735 | DeBary | Florida | 32713-2260 | — |
| Neoclinical Research /ID# 254622 | Hialeah | Florida | 33016-1897 | — |
| Gnp Research - Hollywood /ID# 273563 | Hollywood | Florida | 33024 | — |
| Life Clinical Trials /ID# 256061 | Margate | Florida | 33063 | — |
| Lakes Research, LLC /ID# 255023 | Miami | Florida | 33014 | — |
| HMD Research LLC /ID# 253732 | Orlando | Florida | 32819 | — |
| Millennium Research /ID# 253744 | Ormond Beach | Florida | 32174 | — |
| Vitalia Research /ID# 274213 | Palm Beach Gardens | Florida | 33410 | — |
| BayCare Medical Group /ID# 253799 | St. Petersburg | Florida | 33705 | — |
| Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 254649 | Tampa | Florida | 33606 | — |
| Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 255264 | Tampa | Florida | 33606 | — |
| University of South Florida- Neuroscience Institute /ID# 253745 | Tampa | Florida | 33613 | — |
| Baycare Medical Group - Tampa /ID# 255268 | Tampa | Florida | 33614 | — |
| Atlanta Research Center For Rheumatology - Marietta /ID# 254623 | Marietta | Georgia | 30060 | — |
| Next Innovative Clinical Research - Chicago /ID# 273453 | Chicago | Illinois | 60616 | — |
| Deerbrook Medical Associates /ID# 254008 | Libertyville | Illinois | 60048 | — |
| OrthoIllinois /ID# 254057 | Rockford | Illinois | 61114-4937 | — |
| Greater Chicago Specialty Physicians /ID# 254000 | Schaumburg | Illinois | 60195-3106 | — |
| Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253999 | Skokie | Illinois | 60076 | — |
| Willow Rheumatology and Wellness, PLLC /ID# 254712 | Willowbrook | Illinois | 60527 | — |
| Qualmedica Research - Evansville /ID# 254005 | Evansville | Indiana | 47715-2813 | — |
| Western KY Rheumatology /ID# 255026 | Hopkinsville | Kentucky | 42240 | — |
| Bluegrass Community Research /ID# 254653 | Lexington | Kentucky | 40504 | — |
| Ochsner Health Center - The Grove /ID# 254059 | Baton Rouge | Louisiana | 70836 | — |
| The Arthritis & Diabetes Clinic, Inc. /ID# 254014 | Monroe | Louisiana | 71203 | — |
| Rheumatology Associates PA - Portland /ID# 255014 | Portland | Maine | 04102-2643 | — |
| Beth Israel Deaconess Medical Center - Rheumatology /ID# 255029 | Boston | Massachusetts | 02149-4903 | — |
| AA Medical Research Center - Grand Blanc /ID# 254007 | Grand Blanc | Michigan | 48439 | — |
| Advanced Rheumatology, PC /ID# 256059 | Okemos | Michigan | 48910 | — |
| St. Paul Rheumatology, PA /ID# 255037 | Eagan | Minnesota | 55121 | — |
| Arthritis Associates /ID# 253992 | Hattiesburg | Mississippi | 39402 | — |
| Kansas City Physician Partners /ID# 255035 | Kansas City | Missouri | 64151 | — |
| Clinvest Research LLC /ID# 254054 | Springfield | Missouri | 65807 | — |
| Logan Health Research - Glacier View Research Institute - Rheumatology /ID# 253738 | Kalispell | Montana | 59901 | — |
| Physician Research Collaboration, LLC /ID# 254012 | Lincoln | Nebraska | 68516 | — |
| Dartmouth-Hitchcock Medical Center /ID# 253798 | Lebanon | New Hampshire | 03756 | — |
| Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 255266 | Voorhees Township | New Jersey | 08043 | — |
| Arthritis and Osteoporosis Associates of New Mexico /ID# 252684 | Las Cruces | New Mexico | 88011 | — |
| NYU Langone Ambulatory Care Brooklyn Heights /ID# 254621 | Brooklyn | New York | 11201 | — |
| Joint And Muscle Research Institute /ID# 275128 | Charlotte | North Carolina | 28204 | — |
| Trinity Health Med Arts Clinic /ID# 254010 | Minot | North Dakota | 58701 | — |
| Paramount Medical Research and Consulting /ID# 254048 | Middleburg Heights | Ohio | 44130 | — |
| Rheumatology Associates of Oklahoma /ID# 253994 | Oklahoma City | Oklahoma | 73116-7226 | — |
| Clinical Research of Philadelphia, LLC /ID# 255025 | Philadelphia | Pennsylvania | 19114 | — |
| West Tennessee Research Institute /ID# 254620 | Jackson | Tennessee | 38305 | — |
| Arthritis and Rheumatology Research Institute, PLLC /ID# 254045 | Allen | Texas | 75013-6147 | — |
| Tekton Research, L.L.C /ID# 254004 | Austin | Texas | 78745 | — |
| Trinity Universal Research Associates - Carrollton /ID# 254648 | Carrollton | Texas | 75007 | — |
| Adriana Pop-Moody MD Clinic PA /ID# 255030 | Corpus Christi | Texas | 78404 | — |
| JPS Rheumatology Clinic /ID# 254050 | Fort Worth | Texas | 76104-4917 | — |
| Biopharma Informatic - Houston - Business Center Drive /ID# 254051 | Houston | Texas | 77043 | — |
| Accurate Clinical Research - Houston /ID# 254647 | Houston | Texas | 77089-6142 | — |
| Research Physicians Network, LLC /ID# 254053 | Houston | Texas | 77089 | — |
| R & H Clinical Research - 777 Katy /ID# 255024 | Katy | Texas | 77450-2244 | — |
| West Texas Clinical Research /ID# 253736 | Lubbock | Texas | 79424 | — |
| Trinity Universal Research Associates, Inc /ID# 253995 | Plano | Texas | 75024-5283 | — |
| Sun Research Institute /ID# 255019 | San Antonio | Texas | 78215 | — |
| Advanced Rheumatology of Houston /ID# 254003 | The Woodlands | Texas | 77382 | — |
| DM Clinical Research - Tomball /ID# 254001 | Tomball | Texas | 77375 | — |
| Rheumatology Clinic of Houston /ID# 254002 | Tomball | Texas | 77377 | — |
| Aurora Rheumatology and Immunotherapy Center /ID# 254049 | Franklin | Wisconsin | 53132 | — |
| Rheumatic Disease Center, LLP /ID# 254015 | Glendale | Wisconsin | 53217 | — |
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 133 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05814627, 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 Aug 14, 2026 · Synced Oct 30, 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 NCT05814627 live on ClinicalTrials.gov.