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NCT03682705 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis
A Phase 2 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 2
- Development phase
- 242
- Enrollment target
NCT03682705: Completed Phase 2 study, sponsored by AbbVie.
NCT03682705 is a Phase 2 study that has completed, run by AbbVie. The registered enrollment target is 242 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03682705, a Phase 2 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 242 participants
- Enrollment target
Study Summary
This was a phase 2 study to evaluate the safety and efficacy of elsubrutinib (ELS) and ABBV-599 (ELS plus upadacitinib \[UPA\]) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs (bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.
Primary Outcome
The DAS28-CRP 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-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in dis
Interventions
- DRUG Upadacitinib
- DRUG Placebo for upadacitinib
- DRUG Elsubrutinib
- DRUG Placebo for elsubrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2018-10-08 |
| Est. Completion | 2020-03-26 |
| Phase | Phase 2 |
What the finished NCT03682705 record still lists
NCT03682705 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% higher).
The record links to 0 conditions, and to 4 interventions - of which Upadacitinib is the first listed.
NCT03682705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03682705 about?
NCT03682705 is a clinical study titled "A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis". This was a phase 2 study to evaluate the safety and efficacy of elsubrutinib (ELS) and ABBV-599 (ELS plus upadacitinib \[UPA\]) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) ...
What is the current status of trial NCT03682705?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 242 participants. The study started on 2018-10-08. Estimated completion is 2020-03-26.
What interventions are being tested in trial NCT03682705?
The interventions under investigation include: Upadacitinib (DRUG), Placebo for upadacitinib (DRUG), Elsubrutinib (DRUG), Placebo for elsubrutinib (DRUG).
Who is sponsoring clinical trial NCT03682705?
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 NCT03682705's enrollment target sits among peer trials
242 237th of 2000 higher than 1,762 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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