Spondylitis Trial of Apremilast for Better Rheumatic Therapy

Sponsor
Imperial College London
Study ID
NCT00944658
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks
  • Placebo (sugar pill) — DRUG
    twice a day

Study Details

This study will evaluate the effectiveness of apremilast in AS as measured by improvement in patients' signs and symptoms of the disease and changes in imaging. Additionally the safety and tolerability of apremilast in AS will be assessed.

Key Dates

First listed
Jul 23, 2009
Start date
Aug 31, 2009
Status verified
Nov 2019
Primary completion
Jan 31, 2011
Completion
Jan 31, 2011

Study Design

Enrollment
38 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    placebo twice a day for 12 weeks, 4 weeks follow up
  • Active Comparator: Apremilast
    30 mg twice a day for 12 weeks, 4 weeks follow up

Primary Outcome Measure

Changes of Apremilast in Patients With AS, Changes in BASDAI Score From Baseline [ Time Frame: Baseline and 12 weeks ]

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