Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Ankylosing Spondyloarthritis

In brief

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 facts

Study ID

NCT01583374

Run by

Amgen

People needed

490

Starts

2012-05-02

Expected to finish

2018-10-25

Last updated by the study team

2020-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• University of California, San Diego — La Jolla, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• UCSF Arthritis Center — San Francisco, California, United States
• Advent Clinical Research Centers, Inc — Pinellas Park, Florida, United States
• Burnette & Silverfield, MDS PLC — Tampa, Florida, United States
• Alastair Kennedy, MD Research — Vero Beach, Florida, United States
• Northwestern Medical Faculty Foundation — Chicago, Illinois, United States
• Klein and Associates MD, PA — Cumberland, Maryland, United States
• Klein and Associates MD, PA — Hagerstown, Maryland, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Saint Paul Rheumatology, PA — Eagan, Minnesota, United States
• MetroHealth Medical Systems — Cleveland, Ohio, United States
• STAT Research, Inc. — Dayton, Ohio, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• The Arthritis Clinic — Jackson, Tennessee, United States
• Ramesh C Gupta MD — Memphis, Tennessee, United States
• Austin Regional Clinic — Austin, Texas, United States
• University of Utah Hospitals and Clinics — Salt Lake City, Utah, United States
• Rheumatology and Immunotherapy Center — Franklin, Wisconsin, United States
• Southern Clinical Research — Hobart, Tasmania, Australia
• Emeritus Research — Camberwell, Victoria, Australia
• Coastal Joint Care — Maroochydore, Australia
• Royal Perth Hospital — Perth, Australia
• The Queen Elizabeth Hospital — Woodville South, Australia
• Sun Valley Arthritis Center — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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