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 spine arthritisinflammation of the spine and joints1000381610023213
- Registration Number
- NL-OMON41245
- Lead Sponsor
- AbbVie B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 54
Main Inclusion: ;- Adult subjects with inadequate response of 2 or more 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 purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit must be Negative;- Negative TB screening assessment;- Ability to administer subcutaneous injections;- General good health otherwise
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Efficacy Variable<br /><br>The primary efficacy variable is the proportion of subjects who do not<br /><br>experience a flare during Period 2 by Week 68 of the study where a flare is<br /><br>defined as having any 2 consecutive study visits with ASDAS * 2.1.</p><br>
- Secondary Outcome Measures
Name Time Method