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 |
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.
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
sites
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