Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects With Non-Radiographic Axial Spondyloarthritis



Status:Completed
Conditions:Arthritis, Arthritis, Neurology, Orthopedic
Therapuetic Areas:Neurology, Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 99
Updated:2/24/2017
Start Date:May 2013
End Date:February 2017

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A Multicenter, Randomized, Double-Blind, Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects With Non-Radiographic Axial Spondyloarthritis

This is a Multicenter, randomized, double-blind study in subjects with moderate to severe
non-radiographic Axial Spondyloarthritis.

There is a 28-week open-label period followed by a 40-week double-blind, placebo-controlled
period for subjects who meet the randomization criteria. Subjects who flare during the
double-blind period will have an opportunity to receive at least 12-weeks of rescue therapy.


Inclusion Criteria:

- Adult subjects with inadequate response to >/= 2 non-steroidal antiinflammatories
(NSAIDs)

- Subject with axial SpA fulfilling the Assessment of Spondyloarthritis international
Society (ASAS) axial SpA classification criteria

- Subject with evidence of active inflammation in the sacroiliac (SI) joints or spine
on MRI, or elevated hs-CRP

- Negative TB screening assessment

- Ability to administer subcutaneous injections

- General good health otherwise

Exclusion Criteria:

- Prior anti-Tumor Necrosis Factor (TNF) therapy; biologic therapy with a potential
therapeutic impact on SpA or treated with an investigational drug of chemical or
biologic nature within 30 days or 5 half-lives of baseline.

- Fulfillment of the radiographic criterion of the modified New York criteria for
Ankylosing Spondylitis

- Recent infection requiring treatment

- Significant medical events or conditions that may put patients at risk for
participation

- Female subjects who are pregnant or breast-feeding or considering becoming pregnant
during the study
We found this trial at
36
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Clarksburg, West Virginia 26301
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Colorado Springs, Colorado 80910
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Duncansville, Pennsylvania 16635
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