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Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis

NCT01583374 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 490

Last updated 2020-05-12

Study results available
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Summary

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.

Conditions

  • Ankylosing Spondyloarthritis

Interventions

DRUG

Apremilast tablet 20 mg

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

DRUG

Apremilast tablet 30 mg BID

Apremilast 30 mg was taken orally twice a day

DRUG

Placebo

Identically matched placebo tablets were taken orally twice a day during the placebo controlled phase.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-02
Primary Completion
2014-02-24
Completion
2018-10-25

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • Czechia
  • Estonia
  • France
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01583374 on ClinicalTrials.gov