Adalimumab in Axial Spondyloarthritis (ASIM) - MRI and Biomarkers in Patients With Spondyloarthritis

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glostrup University Hospital, Copenhagen; Rigshospitalet, Denmark
• Treatments: Adalimumab

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

• Incapable of complying with the examination program for physical or mental reasons