A Study to Evaluate the Impact of Apremilast (CC-10004) on MRI Outcomes in Subjects With Psoriatic Arthritis
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 120
Summary
- Conditions
- Psoriatic Arthritis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Approximately 120 subjects will receive apremilast 30 mg BID, after a 5-day titration period, with or without MTX. All subjects will be permitted to take NSAIDs and/or low-dose oral glucocorticoids (prednisone ? 10 mg/day or equivalent) throughout the study. The NSAIDs and low-dose oral glucocortico...
Approximately 120 subjects will receive apremilast 30 mg BID, after a 5-day titration period, with or without MTX. All subjects will be permitted to take NSAIDs and/or low-dose oral glucocorticoids (prednisone ? 10 mg/day or equivalent) throughout the study. The NSAIDs and low-dose oral glucocorticoids must be on a stable regimen for at least 4 weeks prior to baseline. MTX (? 25 mg/week) will be permitted if treatment duration is ? 6 months and on a stable regimen for at least 3 months prior to baseline. In addition, Nonsteroidal anti-inflammatory drug (NSAIDs), and low-dose glucocorticoids must be continued from Day 1 through the Week 24 Visit. Change in doses, increase or decrease, and/or discontinuation will not be allowed, except for safety reasons or for lack of availability. After the Week 24 Visit, the doses of MTX, NSAIDs, or glucocorticoids may be adjusted as clinically required.
Tracking Information
- NCT #
- NCT03783026
- Collaborators
- Not Provided
- Investigators
- Study Director: MD Amgen
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