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

Completed

• Conditions: Axial Spondyloarthritis
• Interventions: Drug: Treatment

• Registration Number: NCT02011386
• Lead Sponsor: Professor Mikkel Østergaard

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-13
• Primary Completion: 2017-02-14
• Study Completion: 2017-02-14
• Results First Submitted: 2020-05-26
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-30
• Last Update Submitted: 2020-07-30
• Results First Posted: 2020-08-17
• Last Update Posted: 2020-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	Treatment	Treatment: Injection Golimumab 50 mg every month on the same date

Primary Outcome Measures

Name	Time	Method
Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50)	Week 52	At least 50% reduction in BASDAI score at follow-up compared with BASDAI score at baseline

Secondary Outcome Measures

Name	Time	Method
BASDAI 50% or 2.0 Improvement	Week 52	At least 50% decrease or at least an improvement of 2.0 in BASDAI, when measured on a scale with range 0-10.
Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII)	Week 52	Decrease in ASDAS score at follow-up compared with ASDAS score at baseline of at least 1.1.
MRI Spine Remission	Week 16	Maximum 1 disco-vertebral unit with inflammation present.
MRI-SPINE-50	Week 16	At least 50% reduction in Canada-Denmark (CANDEN) MRI spine inflammation score.

Trial Locations

Locations (6)

Herlev Hospital, Dep. of Radiology; 🇩🇰 Copenhagen, Denmark

Gentofte Hospital, Dep. of Rheumatology; 🇩🇰 Copenhagen, Denmark

Frederiksberg Bispebjerg Hospitals, Dep. of Rheumatology; 🇩🇰 Copenhagen, Denmark

Glostrup Hospital, Dep. of Rheumatology; 🇩🇰 Copenhagen, Denmark

Køge Hospital, Dep. of Rheumatology; 🇩🇰 Køge, Denmark

Nordsjællands Hospital Hillerød, Dep. of Rheumatology; 🇩🇰 Hillerød, Denmark