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

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ClinicalTrials.gov Identifier: NCT01029847
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Mikkel Østergaard, 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.

Condition or disease Intervention/treatment Phase
Spondyloarthritis Drug: Adalimumab Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Study Start Date : December 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo

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.


Active Comparator: Adalimumab
TNF-alpha inhibitor
Drug: Adalimumab
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.




Primary Outcome Measures :
  1. Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50% [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029847


Locations
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Denmark
Dep. of medicine, Herlev Hospital
Copenhagen, Denmark
Dep. of Radiology, Herlev Hospital
Copenhagen, Denmark
Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals
Copenhagen, Denmark
Dep. of Rheumatology, Gentofte Hospital
Copenhagen, Denmark
Dep. of Rheumatology, Hvidovre Hospital
Copenhagen, Denmark
Dep. of Rheumatologym Glostrup Hospital
Copenhagen, Denmark
Dep. of Rheumatology, Helsinør Hospital
Hørsholm, Denmark
Dep. of Rheumatology, Køge Hospital
Køge, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Mikkel Østergaard, Professor Dep. of Rheumatology, Glostrup Hospital
Study Chair: Susanne J Pedersen, MD Dep. of Rheumatology, Glostrup Hospital
Study Chair: Inge J Sørensen Dep. of Rheumatoogy, Glostrup Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Mikkel Østergaard, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01029847    
Other Study ID Numbers: ASIM
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Keywords provided by Professor Mikkel Østergaard, Rigshospitalet, Denmark:
Patients with axial spondyloarthritis
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents