Adalimumab in Axial Spondyloarthritis. An Investigation of Whole-body MRI, MRI of Sacroiliac Joints and Spine and Soluble Biomarkers of Joint Inflammation and Damage.

Rigshospitalet, Denmark8 sites in 1 country49 target enrollmentDecember 2009

ConditionsSpondyloarthritis

InterventionsPlacebo Adalimumab

DrugsAdalimumab Placebo

Overview

Phase: Phase 4
Intervention: Placebo
Conditions: Spondyloarthritis
Sponsor: Rigshospitalet, Denmark
Enrollment: 49
Locations: 8
Primary Endpoint: Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Investigation of wholebody MRI and circulating biomarkers of inflammation, cartilage and bone metabolism in patients with spondyloarthritis treated with adalimumab. Furthermore to compare ultrasound examination with wholebody MRI etc.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

December 2013

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rigshospitalet, Denmark

Responsible Party

Principal Investigator

Professor Mikkel Østergaard

Professor

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

•Spondyloarthritis (SpA) according to the new ASAS criteria for axial SpA
•BASDAI \> 40 mm despite NSAIDs
•Clinical indication for treatment with TNF-alpha inhibitor
•Age \> 18 years old and \< 85 years old
•Sufficient contraception for women
•Capable of giving informed consent
•Capable of complying with the examination program of the protocol

Exclusion Criteria

•Pregnancy wish, pregnancy or breast-feeding
•DMARDs within 4 weeks prior to inclusion
•Oral, intra-articular or intramuscular glucocorticoid within 4 weeks prior to inclusion
•The use of other study drugs within 4 weeks prior to inclusion or less than 5 half-lives of the study drug before inclusion if this is more than 4 weeks
•The use of suspected disease-modifying or immunosuppressive drugs within 4 weeks prior to inclusion
•DMARDs are allowed during the study, but the dose cannot be changed from 4 weeks prior to inclusion through week
•Contraindications for TNF-α inhibitor treatment
•Contraindications for MRI
•Known recent drug or alcohol abuse
•Failure to provide written consent

Arms & Interventions

Placebo

Intervention: Placebo

Adalimumab

TNF-alpha inhibitor

Intervention: Adalimumab

Outcomes

Primary Outcomes

Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%

Time Frame: 24 weeks

Secondary Outcomes

Number of peripheral and axial joints and entheses with inflammation, circulating biomarkers of inflammation, cartilage and bone metabolism, conventional clinical parameters and changes in these during treatment with adalimumab.(24 week)