(MOSAIC) A Study to Evaluate the Impact of Apremilast (CC-10004) on MRI Outcomes in Subjects With Psoriatic Arthritis
This study explores the effectiveness of the drug Apremilast when used to prevent progression of Psoriatic arthritis (PsA). It will measure outcomes using MRI results as evidence of slowing or stopping disease activity. Patients who have a diagnosis of PsA made within the prior 5 years are invited to contact the study team to see if they qualify for enrollment in this study.
- Males or females, aged 18 years or older at time of consent
- Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
- Able to adhere to the study visit schedule and other protocol requirements
- Have a documented diagnosis of PsA of ≥ 3 months AND ≤ 5 years in duration, meeting the CASPAR criteria for PsA at the time of Screening Visit
- Have ≥ 3 swollen AND ≥ 3 tender joints, with hand involvement (defined as ≥ 1 swollen joint or dactylitis [each clinically active joint of a dactylitic digit is counted as one joint]).
- Must not have been treated previously with a TNF blocker or other biologic drug for PsA treatment
- Must not have been treated with more than 2 csDMARDs
- Subjects taking csDMARDs, with the exception of MTX, cyclosporine, or LEF, do not require a washout period. However, they must discontinue the csDMARD treatment at least one day prior to their Baseline Visit (ie, Visit 2, Day 1)
- Subjects who have been previously treated with MTX for < 6 months and who are not on stable doses for at least 3 months will require a 28-day washout prior to the Baseline Visit (ie, Visit 2, Day 1) to participate in the study
- Subjects who have been previously treated with LEF will require a 12-week washout prior to the Baseline Visit (ie, Visit 2, Day 1), or treatment with cholestyramine, per LEF prescribing label (ie, 8 g cholestyramine 3 times daily for 11 days)
- Subjects who have been previously treated with cyclosporine will require a 28-day washout prior to the Baseline Visit (ie, Visit 2, Day 1) to participate in the study
- If taking MTX (≤ 25 mg/week), continuity of treatment will be allowed if duration of treatment is ≥ 6 months and on a stable dose for at least 3 months prior to the Baseline Visit (ie, Visit 2, Day 1)
- If taking oral glucocorticoids, must be on a stable dose of prednisone ≤ 10 mg/day or equivalent for at least 4 weeks prior to the Baseline Visit (ie, Visit 2, Day 1)
- If taking NSAIDs or narcotic analgesics, must be on stable dose for at least 4 weeks prior to Baseline Visit (ie, Visit 2, Day 1)
- Must be in general good health (except for PsA) as judged by the investigator, based on medical history, physical examination, and clinical laboratories. (Note: The definition of good health means a subject does not have uncontrolled significant comorbid conditions).
Additional inclusion and exclusion criteria apply.
Principal InvestigatorMichael R Bubb, M.D.
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