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: 18.0 Level: PT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-000646-35-NL
• 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: 2013-05-17
• Study Completion: 2017-04-14
• Last Update Posted: 30 June 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 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

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Not applicable;Primary end point(s): The proportion of subjects who do not experience a flare by Week 68 of the study where a flare is defined as having any 2 consecutive study visits with ASDAS = 2.100;Timepoint(s) of evaluation of this end point: The proportion of participants who do not experience a flare by Week 68 of the study where a flare is defined as having any 2 consecutive study visits with ASDAS = 2.100;Main Objective: The objective of this study is to evaluate the efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given every other week (eow) subcutaneously (SC) in maintaining remission in subjects with non-radiographic axial Spondyloarthritis (nr-axSpA).