EUCTR2012-000646-35-DEActive, not recruitingPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 673
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Main Inclusion:
- •- Adult subjects with inadequate response to >/= 2 non-steroidal anti-inflammatories (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 SI joints or spine on MRI, or elevated hs-CRP
- •-Negative Tb screening assessment
- •- 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 678
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
Exclusion Criteria
- •Main Exclusion:
- •- Prior anti-TNF therapy
- •- 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
- •- Female subjects 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
Investigators
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