Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis

Conditions

• Psoriatic Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apremilast 30 mg — DRUG
  30mg of Apremilast will be orally administered twice daily for 104 weeks
• Placebo — DRUG
  Identically appearing Placebo tablets will be orally administered twice daily for up to 24 weeks

Study Details

The purpose of this study is to determine whether apremilast is safe and effective for treating patients with psoriatic arthritis.

Key Dates

First listed

Aug 20, 2013

Start date

Sep 4, 2013

Status verified

Apr 2020

Primary completion

Feb 25, 2015

Completion

Nov 17, 2016

Study Design

Enrollment

219 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Apremilast 30 mg
  30 mg Apremilast tablets administered twice daily (BID) for 24 weeks during the double-blind placebo-controlled phase; followed by 30 mg Apremilast BID for 28 weeks of active treatment phase (up to the 52 week visit); original treatment assignments remain blinded until all participants have completed their 52 week visit or have discontinued. After the Wk 52 visit, all participants in the extension phase will continue to receive treatment with apremilast 30 mg BID until the end of the study (ie, up to Week 104 visit) or until early discontinuation from the trial.
• Placebo Comparator: Placebo
  Oral placebo BID during the placebo controlled phase weeks 0 to 24; placebo treated participants whose improvement is \<10% in both swollen and tender joint counts at Week 16 are eligible for early escape (based on the measure of clinical benefit from their current treatment as evidenced by improvement (or lack of improvement) in 1) the physician (evaluator's) global assessment (EGA), 2) patients pain (pain NRS), 3) the patient global assessments (PGA), and 4) the health assessment questionnaire disability index (HAQ-DI); Placebo-treated patients who early escape are transitioned to apremilast 30 mg PO BID during the active treatment phase up to their Week 52 visit; all those who complete the 52-week treatment phase will enter an open-label extension phase for an additional 52 weeks or until early discontinuation from the trial.

Primary Outcome Measure

Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 16 [ Time Frame: Baseline and Week 16 ]

Locations (24)

Find similar trials in Birmingham, AL

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