A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
Public ClinicalTrials.gov record NCT02706951. 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, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX. The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.
Study identification
- NCT ID
- NCT02706951
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 648 participants
Conditions and interventions
Conditions
Interventions
- Methotrexate Drug
- Upadacitinib Drug
- Placebo Upadacitinib Drug
- Placebo Methotrexate Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- 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
- Mar 23, 2016 (Actual)
- Primary completion
- Oct 2, 2017 (Actual)
- Completion
- Aug 10, 2022 (Actual)
- Last update posted
- Jan 30, 2024
2016 – 2022
United States locations
- U.S. sites
- 52
- U.S. states
- 22
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rheum Assoc of North Alabama /ID# 146009 | Huntsville | Alabama | 35801 | — |
| Alabama Medical Group, PC /ID# 153941 | Mobile | Alabama | 36608-1787 | — |
| ArthroCare Arthritis Care & Re /ID# 143751 | Gilbert | Arizona | 85234 | — |
| Elite Clinical Studies, LLC /ID# 143760 | Phoenix | Arizona | 85018 | — |
| University of Arizona Cancer Center - North Campus /ID# 147175 | Tucson | Arizona | 85719-1478 | — |
| NEA Baptist Womens Clinic /ID# 148904 | Jonesboro | Arkansas | 72401 | — |
| C.V. Mehta MD, Med Corporation /ID# 143762 | Hemet | California | 92543 | — |
| Arthritis Assoc & Osteo Ctr /ID# 147176 | Colorado Springs | Colorado | 80920 | — |
| Ctr Rheum, Immuno, Arthritis /ID# 143766 | Fort Lauderdale | Florida | 33309 | — |
| South Florida Research Ph I-IV /ID# 151983 | Miami Springs | Florida | 33166-7225 | — |
| Advent Clinical Research /ID# 143767 | Pinellas Park | Florida | 33781 | — |
| Sarasota Arthritis Center /ID# 146011 | Sarasota | Florida | 34239 | — |
| W. Broward Rheum Assoc Inc. /ID# 146010 | Tamarac | Florida | 33321 | — |
| Clinical Research West FL /ID# 148726 | Tampa | Florida | 33603 | — |
| SW FL Clin Res Ctr, Tampa, FL /ID# 143763 | Tampa | Florida | 33609 | — |
| University of South Florida /ID# 146004 | Tampa | Florida | 33612 | — |
| BayCare Medical Group, Inc. /ID# 151985 | Tampa | Florida | 33614-7101 | — |
| BayCare Medical Group, Inc. /ID# 163595 | Tampa | Florida | 33614-7101 | — |
| Jefrey D. Lieberman, MD, P.C. /ID# 151816 | Decatur | Georgia | 30033 | — |
| Great Lakes Clinical Trials /ID# 150935 | Chicago | Illinois | 60640 | — |
| PRN Professional Research Network of Kansas, LLC /ID# 143761 | Wichita | Kansas | 67205 | — |
| Ochsner Clinic Foundation /ID# 153573 | Baton Rouge | Louisiana | 70836-6455 | — |
| The Arthritis & Diabetes Clinic, Inc. /ID# 160809 | Monroe | Louisiana | 71203 | — |
| Vanguard Medical Research, LLC /ID# 153124 | Shreveport | Louisiana | 71011 | — |
| Mansfield Health Center /ID# 161627 | Mansfield | Massachusetts | 02048 | — |
| Quality Clinical Research Inc. /ID# 156415 | Omaha | Nebraska | 68114 | — |
| Dartmouth-Hitchcock Medical Center /ID# 146008 | Lebanon | New Hampshire | 03756 | — |
| Albuquerque Clinical Trials, Inc /ID# 147618 | Albuquerque | New Mexico | 87102 | — |
| Arthritis and Osteo Assoc /ID# 147177 | Las Cruces | New Mexico | 88011 | — |
| Coastal Carolina Health Care /ID# 149275 | New Bern | North Carolina | 28562 | — |
| STAT Research, Inc. /ID# 143770 | Vandalia | Ohio | 45377-9464 | — |
| Health Research Oklahoma /ID# 159550 | Oklahoma City | Oklahoma | 73103-2400 | — |
| Healthcare Research Consultant /ID# 147632 | Tulsa | Oklahoma | 74135 | — |
| Innovative Clinical Research /ID# 143757 | Greenville | South Carolina | 29601 | — |
| Nashville Arthritis and Rheumatology /ID# 162641 | Nashville | Tennessee | 37203 | — |
| Tekton Research, Inc. /ID# 159554 | Austin | Texas | 78745 | — |
| Diagnostic Group Integrated He /ID# 148725 | Beaumont | Texas | 77701 | — |
| Trinity Universal Res Assoc /ID# 150138 | Carrollton | Texas | 75007 | — |
| Arth and Osteo Clin Brazo Valley /ID# 160810 | College Station | Texas | 77845 | — |
| Adriana Pop-Moody MD Clinic PA /ID# 147627 | Corpus Christi | Texas | 78404 | — |
| Accurate Clinical Management /ID# 143768 | Houston | Texas | 77004 | — |
| Accurate Clinical Research /ID# 143769 | Houston | Texas | 77089 | — |
| Pioneer Research Solutions, Inc. /ID# 143765 | Houston | Texas | 77098-5294 | — |
| P&I Clinical Research /ID# 151358 | Lufkin | Texas | 75904-3132 | — |
| SW Rheumatology Res. LLC /ID# 147620 | Mesquite | Texas | 75150 | — |
| Sun Research Institute /ID# 159553 | San Antonio | Texas | 78215 | — |
| Arthritis Clinic of Central TX /ID# 149266 | San Marcos | Texas | 78666 | — |
| Adv Rheumatology of Houston /ID# 162609 | The Woodlands | Texas | 77382 | — |
| DM Clinical Research /ID# 151359 | Tomball | Texas | 77375 | — |
| Arthritis & Osteoporosis Clinic /ID# 143752 | Waco | Texas | 76710 | — |
| Ctr for Arth and Rheum Disease /ID# 143759 | Chesapeake | Virginia | 23320 | — |
| Aurora Rheumatology and Immunotherapy Center /ID# 160811 | Franklin | Wisconsin | 53132 | — |
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 101 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02706951, 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 Jan 30, 2024 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02706951 live on ClinicalTrials.gov.