Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01583374
• Date of registration: 20/04/2012
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis POSTURE
• Scientific title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF ACTIVE ANKYLOSING SPONDYLITIS
• Date of first enrolment: May 2, 2012
• Target sample size: 490
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01583374
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Bulgaria, Canada, Czech Republic, Czechia, Estonia, France, Germany, Hungary, Netherlands, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, United Kingdom, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Must have a documented diagnosis of ankylosing spondylitis as defined by low back pain
and stiffness, which improves with exercise, but is not relieved by rest for more than
3 months prior to screening. At the completion of screening procedures, a documented
diagnosis of definite active AS, as defined by the modified New York criteria (1984)
whereby both criteria, at least 1 radiographic criterion and at least 1 clinical
criterion, must be met

- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is = 4

- Total back pain is = 4

- On stable dose of AS medication (or lack of medication) prior to randomization and
through week 24

Exclusion Criteria:

- Prior treatment with a Tumor Necrosis Factor (TNF) blocker and any biologic treatment for
AS



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondyloarthritis

Intervention(s)

Drug: Apremilast tablet 30 mg BID

Drug: Placebo

Drug: Apremilast tablet 20 mg

Primary Outcome(s)

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

Secondary Outcome(s)

Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 104 and Week 260 [Time Frame: Baseline to Week 104 and 260]

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 [Time Frame: Baseline and Week 24]

Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period [Time Frame: Week 0 to week 260; overall mean duration of exposure to apremilast 20 mg and 30 mg BID was 160.96 weeks]

Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS) Response at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index-Linear (BASMI-Linear) at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in the Ankylosing Spondylitis Quality of Life (ASQoL) Summary Score at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in the Physical Component Summary Score (PCS) of Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) at Week 24 [Time Frame: Baseline and Week 24]

Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase [Time Frame: From Week 0 to Week 24; the median duration of exposure was 23.57 weeks for the placebo arm, 23.71 weeks for the apremilast 20 mg arm and 24.00 weeks for the apremilast 30 mg arm.]

Secondary ID(s)

CC-10004-AS-001

2011-001555-37

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/03/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01583374