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NCT02706951 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 648
- Enrollment target
NCT02706951: Completed Phase 3 study, sponsored by AbbVie.
NCT02706951 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 648 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02706951, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 648 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 14. Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response 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: * Physician global assessment of disease activity * P
Interventions
- DRUG Upadacitinib
- DRUG Methotrexate
- DRUG Placebo Upadacitinib
- DRUG Placebo Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 648 participants |
| Start Date | 2016-03-23 |
| Est. Completion | 2022-08-10 |
| Phase | Phase 3 |
What the finished NCT02706951 record still lists
NCT02706951 is an interventional study that assigns participants to a tested intervention. The registered 648 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 4 interventions - of which Upadacitinib is the first listed.
NCT02706951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02706951 about?
NCT02706951 is a clinical study titled "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)". 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 resp...
What is the current status of trial NCT02706951?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 648 participants. The study started on 2016-03-23. Estimated completion is 2022-08-10.
What interventions are being tested in trial NCT02706951?
The interventions under investigation include: Upadacitinib (DRUG), Methotrexate (DRUG), Placebo Upadacitinib (DRUG), Placebo Methotrexate (DRUG).
Who is sponsoring clinical trial NCT02706951?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02706951's enrollment target sits among peer trials
648 572nd of 2000 higher than 1,429 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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