Study of Adalimumab in Patients With Axial Spondyloarthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Axial Spondyloarthritis

In brief

This study will evaluate how well adalimumab works in the short and long term in patients with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.

Key facts

Study ID

NCT00939003

Run by

AbbVie (prior sponsor, Abbott)

People needed

192

Starts

2009-07-01

Expected to finish

2013-08-01

Last updated by the study team

2014-09-09

Who can join

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

You may qualify if…

• Adult patients with inadequate response to >/= 1 non-steroidal anti-inflammatory drugs (NSAIDs)
• Chronic back pain with onset < 45 years of age
• Magnetic resonance imaging (MRI) indicating active sacroiliitis or positive human leukocyte antigen-B27 (HLA-B27) blood test in addition to meeting spondyloarthritis clinical criteria
• Negative purified protein derivative (PPD) test and chest x-ray performed at Baseline visit must be negative
• Ability to administer subcutaneous injections
• General good health otherwise

You may not qualify if…

• Prior anti-tumor necrosis factor (TNF) therapy
• Psoriasis or psoriatic arthritis
• Fulfillment of modified New York criteria for ankylosing spondylitis
• Recent infection requiring treatment
• Significant medical events or conditions that may put patients at risk for participation
• Females who are pregnant or breast-feeding or considering becoming pregnant during the study
• History of cancer, except successfully treated skin cancer
• Recent history of drug or alcohol abuse

Where it is running

• Site Reference ID/Investigator# 21250 — Birmingham, Alabama, United States
• Site Reference ID/Investigator# 21249 — Colorado Springs, Colorado, United States
• Site Reference ID/Investigator# 21245 — Denver, Colorado, United States
• Site Reference ID/Investigator# 21246 — Wheaton, Maryland, United States
• Site Reference ID/Investigator# 26582 — Duncansville, Pennsylvania, United States
• Site Reference ID/Investigator# 21241 — Wyomissing, Pennsylvania, United States
• Site Reference ID/Investigator# 21243 — Dallas, Texas, United States
• Site Reference ID/Investigator# 21248 — Houston, Texas, United States
• Site Reference ID/Investigator# 21247 — Seattle, Washington, United States
• Site Reference ID/Investigator# 22342 — Brisbane, Australia
• Site Reference ID/Investigator# 21223 — Kogarah, Australia
• Site Reference ID/Investigator# 21222 — Maroochydore, Australia
• Site Reference ID/Investigator# 21225 — Genk, Belgium
• Site Reference ID/Investigator# 21224 — Ghent, Belgium
• Site Reference ID/Investigator# 26544 — Gilly, Belgium
• Site Reference ID/Investigator# 27382 — Merksem, Belgium
• Site Reference ID/Investigator# 21229 — Edmonton, Canada
• Site Reference ID/Investigator# 21226 — Sainte-Foy, Quebec, Canada
• Site Reference ID/Investigator# 21227 — St. John's, Canada
• Site Reference ID/Investigator# 21228 — Toronto, Canada
• Site Reference ID/Investigator# 21231 — Brno, Czechia
• Site Reference ID/Investigator# 26882 — Pardubice, Czechia
• Site Reference ID/Investigator# 21230 — Prague, Czechia
• Site Reference ID/Investigator# 26883 — Uherské Hradiště, Czechia
• Site Reference ID/Investigator# 21263 — Boulogne-Billancourt, France

Full record on ClinicalTrials.gov

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