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NCT03086343 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 657
- Enrollment target
NCT03086343: Completed Phase 3 study, sponsored by AbbVie.
NCT03086343 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 657 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03086343, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 657 participants
- Enrollment target
Study Summary
The study objective of Period 1 was to compare the safety and efficacy of upadacitinib 15 mg once daily (QD) to abatacept on a background of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in biologic disease-modifying antirheumatic drug (bDMARD)-inadequate response or bDMARD-intolerant participants with moderately to severely active RA. The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD in participants with RA who had completed Period 1.
Primary Outcome
The Disease Activity Score (DAS) 28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates
Interventions
- DRUG Abatacept
- DRUG Upadacitinib
- DRUG Placebo for upadacitinib
- DRUG Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 657 participants |
| Start Date | 2017-05-09 |
| Est. Completion | 2023-06-06 |
| Phase | Phase 3 |
What the finished NCT03086343 record still lists
NCT03086343 is an interventional study that assigns participants to a tested intervention. The registered 657 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 (15% lower).
The record links to 0 conditions, and to 4 interventions - of which Abatacept is the first listed.
NCT03086343 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03086343 about?
NCT03086343 is a clinical study titled "A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs". The study objective of Period 1 was to compare the safety and efficacy of upadacitinib 15 mg once daily (QD) to abatacept on a background of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in biologic diseas...
What is the current status of trial NCT03086343?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 657 participants. The study started on 2017-05-09. Estimated completion is 2023-06-06.
What interventions are being tested in trial NCT03086343?
The interventions under investigation include: Abatacept (DRUG), Upadacitinib (DRUG), Placebo for upadacitinib (DRUG), Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion) (DRUG).
Who is sponsoring clinical trial NCT03086343?
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 NCT03086343's enrollment target sits among peer trials
657 564th of 2000 higher than 1,436 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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