CC-10004-PSA-002 Apremilast in Active Psoriatic Arthritis

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects with Active Psoriatic Arthritis

• IRAS ID

  58853

• Contact name

  Ade Adebajo

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2010-018385-23

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Psoriatic arthritis is an inflammatory (associated with swelling and pain) arthritis that occurs in 25-40% of psoriasis patients. This study, sponsored by Celgene Corporation, will test the effects of an experimental oral drug called apremilast. Previous trials in humans have shown that apremilast can reduce inflammation and improve the symptoms such as joint pain, redness and swelling associated with psoriatic arthritis. Apremilast works by altering the levels of some of the chemicals in the body that cause swelling and therefore improves the symptoms of psoriatic arthritis. The purpose of this study is to test two doses of apremilast (20 or 30 mg twice daily) and compare its effects to placebo (a ??dummy drug??). The study consists of phases: Screening Phase of up to 4 weeks; Placebo-Controlled Phase of up to 24 weeks; Active Treatment/Long-term Safety Phase of up to 236 weeks and Observational Follow-up Phase of up to 4 weeks. Participants will receive either placebo, apremilast 20 mg twice daily or apremilast 30 mg twice daily for the first 24 weeks. Some participants will switch from placebo to apremilast after 16 weeks of treatment, but all patients will be switched to apremilast after 24 weeks. However, treatment will continue to be blinded through the first 52 weeks of the study (that is, neither the participants nor the study investigators will know what treatment the participants are receiving). Approximately 495 participants worldwide will take part. Each participant will be in the study for approximately 5 years. There will be regular study visits during the study; most visits occur every 3 months when procedures such as ECGs, blood tests, patient questionnaires and physical examinations will be performed.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  10/H1307/126

• Date of REC Opinion

  23 Dec 2010

• REC opinion

  Further Information Favourable Opinion