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NCT03725202 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 429
- Enrollment target
NCT03725202 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 429 participants.
The verdict
NCT03725202, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 429 participants
- Enrollment target
Study Summary
This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of Period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1.
Interventions
- OTHER Placebo
- DRUG Upadacitinib
- DRUG Corticosteroid (CS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 429 participants |
| Start Date | 2019-01-24 |
| Est. Completion | 2025-03-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03725202
The ClinicalTrials.gov registry entry for NCT03725202 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 429 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 3 interventions - of which Placebo is the first listed.
NCT03725202 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03725202 about?
NCT03725202 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis". This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained rem...
What is the current status of trial NCT03725202?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 429 participants. The study started on 2019-01-24. Estimated completion is 2025-03-11.
What interventions are being tested in trial NCT03725202?
The interventions under investigation include: Placebo (OTHER), Upadacitinib (DRUG), Corticosteroid (CS) (DRUG).
Who is sponsoring clinical trial NCT03725202?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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