Overview

This trial is active, not recruiting.

Condition axial spondyloarthritis
Treatments adalimumab, placebo
Phase phase 4
Target TNF-alpha
Sponsor AbbVie
Start date May 2013
End date May 2017
Trial size 740 participants
Trial identifier NCT01808118, 2012-000646-35, M13-375

Summary

This is a Multicenter, randomized, double-blind study in subjects with moderate to severe non-radiographic Axial Spondyloarthritis.

There is a 28-week open-label period followed by a 40-week double-blind, placebo-controlled period for subjects who meet the randomization criteria. Subjects who flare during the double-blind period will have an opportunity to receive at least 12-weeks of rescue therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
40 mg every other week (eow), Weeks 0-28. If subjects flare during the double-blind period, subjects will have an opportunity to receive at least 12 weeks of adalimumab 40 mg eow.
adalimumab Humira
40 mg every other week
(Placebo Comparator)
Placebo every other week (eow), Weeks 28-68. Placebo will be discontinued in subjects who meet the criteria for flare.
placebo
every other week
(Experimental)
40 mg every other week (eow), Weeks 28-68.
adalimumab Humira
40 mg every other week

Primary Outcomes

Measure
The proportion of participants who do not experience a flare during period 2 by Week 68 of the study where a flare is defined as having any 2 consecutive study visits with ASDAS ≥ 2.100
time frame: Up to Week 68

Secondary Outcomes

Measure
Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease (ASDAS < 1.300)
time frame: Up to Week 68
ASDAS Major Improvement (a change from baseline ≤ -2.000)
time frame: Up to Week 68
ASDAS Clinically Important Improvement (a change from baseline ≤ -1.100)
time frame: Up to Week 68
Assessment of Spondyloarthritis International Society (ASAS20)
time frame: Up to Week 68
Assessment of Spondyloarthritis International Society (ASAS40)
time frame: Up to Week 68
Assessment of Spondyloarthritis International Society (ASAS 5/6)
time frame: Up to Week 68
ASAS Partial Remission
time frame: Up to Week 68
Bath AS Disease Activity Index 50 (BASDAI50)
time frame: Up to Week 68

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - Adult subjects with inadequate response to >/= 2 non-steroidal antiinflammatories (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 sacroiliac (SI) joints or spine on MRI, or elevated hs-CRP - Negative TB screening assessment - Ability to administer subcutaneous injections - General good health otherwise Exclusion Criteria: - Prior anti-Tumor Necrosis Factor (TNF) therapy; biologic therapy with a potential therapeutic impact on SpA or treated with an investigational drug of chemical or biologic nature within 30 days or 5 half-lives of baseline. - Fulfillment of the radiographic criterion of the 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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.