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Completed

NCT Number: NCT01029847

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

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.

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Key information

Conditions

Spondyloarthritis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dep. of Radiology, Herlev Hospital, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adalimumab

Drug

Sc. inj. adalimumab 40 mg every other week for 42 to 48 weeks. At week 24, clinical non-responders (not fulfilling primary outcome measure) were allowed treatment with other drugs, following local treatment guidelines.

Placebo

Drug

sc. inj. placebo every other week, week 0, 2, and 4. Sc. inj. adalimumab 40 mg every other week from week 6.

At week 24, clinical non-responders (not fulfilling primary outcome measure) were allowed treatment with other drugs, following local treatment guidelines.

Primary outcomes

  1. Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50%

    Time frame: 24 weeks

Secondary outcomes

  1. 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.

    Time frame: 24 week

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Adalimumab in Axial Spondyloarthritis. An Investigation of Whole-body MRI, MRI of Sacroiliac Joints and Spine and Soluble Biomarkers of Joint Inflammation and Damage.

Acronym: ASIM

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Dec 10, 2009
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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