A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate
Public ClinicalTrials.gov record NCT02706873. 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) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objectives of Period 1 were the following: * To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy (for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in methotrexate-naïve adults with moderately to severely active RA; * To compare the efficacy of upadacitinib 15 mg QD monotherapy and upadacitinib 30 mg QD monotherapy versus weekly methotrexate monotherapy for prevention of structural progression in methotrexate-naïve adults with moderately to severely active RA. The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults with RA who have completed Period 1.
Study identification
- NCT ID
- NCT02706873
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,002 participants
Conditions and interventions
Conditions
Interventions
- Placebo to Upadacitinib Drug
- Methotrexate Drug
- Placebo to Methotrexate Drug
- 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
- Feb 23, 2016 (Actual)
- Primary completion
- Mar 15, 2018 (Actual)
- Completion
- Nov 10, 2022 (Actual)
- Last update posted
- Jul 7, 2023
2016 – 2022
United States locations
- U.S. sites
- 32
- U.S. states
- 13
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| TriWest Research Associates- La Mesa /ID# 143738 | La Mesa | California | 91942 | — |
| Desert Medical Advances /ID# 143730 | Palm Desert | California | 92260 | — |
| International Medical Research - Daytona /ID# 143748 | Daytona Beach | Florida | 32117 | — |
| FL Med Ctr and Research, Inc. /ID# 143724 | Miami | Florida | 33142 | — |
| Millennium Research /ID# 143736 | Ormond Beach | Florida | 32174 | — |
| Arthritis Research of Florida /ID# 143743 | Palm Harbor | Florida | 34684-2672 | — |
| Sarasota Arthritis Center /ID# 145978 | Sarasota | Florida | 34239 | — |
| FL Med Clinic, PA /ID# 143744 | Zephyrhills | Florida | 33542 | — |
| Deerbrook Medical Associates /ID# 143728 | Vernon Hills | Illinois | 60061 | — |
| Four Rivers Clinical Research /ID# 143741 | Paducah | Kentucky | 42003 | — |
| Ocean Rheumatology, PA /ID# 143737 | Toms River | New Jersey | 08755 | — |
| Arthritis Rheumatic Back Disorder /ID# 143733 | Voorhees Township | New Jersey | 08043 | — |
| Trinity Health Med Arts Clinic /ID# 143727 | Minot | North Dakota | 58701 | — |
| STAT Research, Inc. /ID# 143750 | Vandalia | Ohio | 45377-9464 | — |
| Healthcare Research Consultant /ID# 143747 | Tulsa | Oklahoma | 74135 | — |
| Advanced Rheumatology & Arthri /ID# 147947 | Wexford | Pennsylvania | 15090 | — |
| Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 145653 | Summerville | South Carolina | 29486-7887 | — |
| West Tennessee Research Inst /ID# 143723 | Jackson | Tennessee | 38305 | — |
| Dr. Ramesh Gupta /ID# 143732 | Memphis | Tennessee | 38119 | — |
| Diagnostic Group Integrated He /ID# 152921 | Beaumont | Texas | 77701 | — |
| Adriana Pop-Moody MD Clinic PA /ID# 147626 | Corpus Christi | Texas | 78404 | — |
| Doctor's Hosp at Renaissance /ID# 156407 | Edinburg | Texas | 78539 | — |
| MedResearch Inc. /ID# 156409 | El Paso | Texas | 79935 | — |
| Rheumatic Disease Clin Res Ctr /ID# 151103 | Houston | Texas | 77004 | — |
| Accurate Clinical Research /ID# 143749 | Houston | Texas | 77089 | — |
| SW Rheumatology Res. LLC /ID# 143745 | Mesquite | Texas | 75150 | — |
| Sun Research Institute /ID# 159546 | San Antonio | Texas | 78215 | — |
| Accurate Clinical Management /ID# 159543 | San Antonio | Texas | 78229 | — |
| NextGen Clinical Trials LLP /ID# 150930 | San Antonio | Texas | 78229 | — |
| Arthritis Clinic of Central TX /ID# 159541 | San Marcos | Texas | 78666 | — |
| Arthritis & Osteoporosis Clinic /ID# 159542 | Waco | Texas | 76710 | — |
| Arthritis Clinic of N. VA, P.C /ID# 143734 | Arlington | Virginia | 22205 | — |
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 258 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02706873, 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 7, 2023 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02706873 live on ClinicalTrials.gov.