Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis

Conditions

• Ankylosing Spondyloarthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apremilast tablet 20 mg — DRUG
  Apremilast 20 mg was taken orally twice a day (BID)
• Apremilast tablet 30 mg BID — DRUG
  Apremilast 30 mg was taken orally twice a day
• Placebo — DRUG
  Identically matched placebo tablets were taken orally twice a day during the placebo controlled phase.

Study Details

Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.

Key Dates

First listed

Apr 24, 2012

Start date

May 2, 2012

Status verified

Oct 2019

Primary completion

Feb 24, 2014

Completion

Oct 25, 2018

Study Design

Enrollment

490 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Apremilast 20 mg
  Apremilast 20 mg was taken orally twice a day (BID)
• Experimental: Apremilast 30 mg
  Apremilast 30 mg was taken orally twice a day
• Placebo Comparator: Placebo
  Identically matched placebo tablets were taken orally twice a day

Primary Outcome Measure

Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16 [ Time Frame: Baseline and Week 16 ]

Locations (20)

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