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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 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 657 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03086343
The ClinicalTrials.gov registry entry for NCT03086343 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 657 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Abatacept is the first listed.
NCT03086343 reports 0 study locations.
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.
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