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

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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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

49 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Adalimumab
Active Comparator group
Description:
TNF-alpha inhibitor
Treatment:
Drug: Adalimumab

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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