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NCT02706873 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,002
- Enrollment target
NCT02706873: Completed Phase 3 study, sponsored by AbbVie.
NCT02706873 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 1,002 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02706873, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,002 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 50% response (ACR50) at Week 12. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * P
Interventions
- DRUG Upadacitinib
- DRUG Methotrexate
- DRUG Placebo to Upadacitinib
- DRUG Placebo to Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,002 participants |
| Start Date | 2016-02-23 |
| Est. Completion | 2022-11-10 |
| Phase | Phase 3 |
What the finished NCT02706873 record still lists
NCT02706873 is an interventional study that assigns participants to a tested intervention. Its 1,002 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 4 interventions - of which Upadacitinib is the first listed.
NCT02706873 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02706873 about?
NCT02706873 is a clinical study titled "A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate". 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 R...
What is the current status of trial NCT02706873?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,002 participants. The study started on 2016-02-23. Estimated completion is 2022-11-10.
What interventions are being tested in trial NCT02706873?
The interventions under investigation include: Upadacitinib (DRUG), Methotrexate (DRUG), Placebo to Upadacitinib (DRUG), Placebo to Methotrexate (DRUG).
Who is sponsoring clinical trial NCT02706873?
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 NCT02706873's enrollment target sits among peer trials
1,002 295th of 2000 higher than 1,706 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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