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

Phase 4

Completed

• Conditions: Spondyloarthritis
• Interventions: Drug: Placebo; Drug: Adalimumab

• Registration Number: NCT01029847
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-09
• Study First Posted: 2009-12-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Adalimumab	Adalimumab	TNF-alpha inhibitor

Primary Outcome Measures

Name	Time	Method
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%	24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

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

Dep. of Rheumatology, Helsinør Hospital; 🇩🇰 Hørsholm, Denmark

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

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

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

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

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

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