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NCT02919761 · ClinicalTrials.gov registry record · Phase 4
Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
A Phase 4 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 4
- Development phase
- 259
- Enrollment target
NCT02919761: Completed Phase 4 study, sponsored by Mallinckrodt.
NCT02919761 is a Phase 4 study that has completed, run by Mallinckrodt. The registered enrollment target is 259 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02919761, a Phase 4 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 259 participants
- Enrollment target
Study Summary
This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease. Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for treatment response using the DAS28-ESR. Participants who have achieved low disease activity (LDA) will enter a double-blind randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either Acthar Gel or matching placebo for an additional 12 weeks. A single participant might be involved in the trial for as many as 32 weeks.
Primary Outcome
LDA is defined as DAS28 \<3.2.
Interventions
- DRUG Placebo
- DRUG Acthar Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2016-11-07 |
| Est. Completion | 2019-02-13 |
| Phase | Phase 4 |
What the finished NCT02919761 record still lists
NCT02919761 is an interventional study that assigns participants to a tested intervention. The registered 259 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02919761 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02919761 about?
NCT02919761 is a clinical study titled "Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis". This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease. Part 1 is an Open Label Period in which all eligible participants receive Acthar...
What is the current status of trial NCT02919761?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 259 participants. The study started on 2016-11-07. Estimated completion is 2019-02-13.
What interventions are being tested in trial NCT02919761?
The interventions under investigation include: Placebo (DRUG), Acthar Gel (DRUG).
Who is sponsoring clinical trial NCT02919761?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02919761's enrollment target sits among peer trials
259 331st of 2000 higher than 1,669 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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