Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis (POSTURE)

Amgen

Status and phase: Completed; Phase 3

Conditions: Ankylosing Spondyloarthritis

Treatments: Drug: Apremilast tablet 20 mg; Drug: Placebo; Drug: Apremilast tablet 30 mg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT01583374

CC-10004-AS-001

2011-001555-37 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

Patients were randomized in a 1:1:1 ratio to placebo, apremilast 20 mg BID and apremilast 30 mg BID. The duration of the study was approximately 5 years. The double blind period (when patients nor the physician knew whether placebo or apremilast was taken) was 24 weeks. At Week 16, participants who did not have either a ≥ 20% improvement or a ≥ 1 unit improvement from baseline in at least two of the four SpondyloArthritis international Society (ASAS) domains were entered in "early escape" from their current treatment in a double-blinded manner. However, such participants were permitted to continue in the study. At Week 24, participants may have entered a long-term extension phase for up to an additional 4.5 years (236 weeks). At "second escape" (at Week 24), apremilast 20 mg BID treated participants transitioned to receive double-blinded apremilast 30 mg BID and remained on double-blinded apremilast 30 mg BID because they continued to improve with a longer duration of treatment. After Week 24 and during the early portion of the long-term extension through Week 52, all participants continued on either double-blinded apremilast 20 mg BID or 30 mg BID treatment. After all participants had completed Week 52 or had terminated early from the study and the 52-week data base was locked, apremilast 20 mg BID or 30 mg BID treatment was provided.

Enrollment: 490 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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490 participants in 3 patient groups, including a placebo group

Apremilast 20 mg

Experimental group

Description:

Apremilast 20 mg was taken orally twice a day (BID)

Treatment:

Drug: Apremilast tablet 20 mg

Apremilast 30 mg

Experimental group

Description:

Apremilast 30 mg was taken orally twice a day

Treatment:

Drug: Apremilast tablet 30 mg BID

Placebo

Placebo Comparator group

Description:

Identically matched placebo tablets were taken orally twice a day

Treatment:

Drug: Placebo