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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 is a Phase 4 study that has completed, run by Mallinckrodt. The registered enrollment target is 259 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02919761
The ClinicalTrials.gov registry entry for NCT02919761 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 259 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02919761 reports 0 study locations.
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.
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