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

Rigshospitalet

Status and phase

Completed

Phase 4

Conditions

Spondyloarthritis

Treatments

Drug: Adalimumab

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01029847

ASIM

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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