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

Phase 1

• Conditions: Axial Spondyloarthritis; MedDRA version: 15.1 Level: LLT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-000646-35-SK
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-28
• Study Completion: 2017-04-14
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 673

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified