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
- Axial SpondyloarthritisMedDRA version: 17.1Level: LLTClassification code 10071400Term: Axial spondyloarthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-000646-35-CZ
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 740
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
- 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method