Novel MRI ANd Biomarkers in GOlimumab-treated Patients With Axial Spondyloarthritis

• Status: Completed
• Trial end date: 2017-02-14
• Target enrollment: 0
• Participant gender: All

Summary

The study investigates different criteria for remission based on MRI and circulating biomarkers for inflammation, cartilage, connective tissue and bone turnover in patients with axial spondyloarthritis treated with Golimumab. Furthermore, the study also investigates factors that affect disease activity, function and participation by use of different questionnaires.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Professor Mikkel Østergaard; Susanne Juhl Pedersen
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Antibodies, Monoclonal; Golimumab

Criteria

Inclusion Criteria:

• Axial spondyloarthritis according to the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axial spondyloarthritis

• Sacroiliitis on conventional X-rays or Magnetic Resonance Imaging (MRI).

• Disease activity assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >40 mm despite treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAID).

• Clinical indication for tumor necrosis factor (TNF) inhibitor treatment by the treating physician.

Exclusion Criteria:

• No contraindications for TNF inhibitor

• No contraindications for MRI

• No contraindications in participation in a study