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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
MOstergaard, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01029847
First received: December 9, 2009
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Spondyloarthritis
Drug: Adalimumab
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
sc. inj. placebo every other week, week 0, 2, and 4. Active treatment from week 6.
Active Comparator: Adalimumab
TNF-alpha inhibitor
Drug: Adalimumab
Sc. inj. Humira 40 mg every other week for 42 to 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029847

Contacts
Contact: Mikkel Østergaard, Professor 004538633014 mo@dadlnet.dk
Contact: susanne J Pedersen, MD, PhD 004541431326 susanne_juhl_ped@dadlnet.dk

Locations
Denmark
Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals Recruiting
Copenhagen, Denmark
Sub-Investigator: Gina Kollerup         
Dep. of Rheumatology, Gentofte Hospital Recruiting
Copenhagen, Denmark
Sub-Investigator: Ole R Madsen         
Sub-Investigator: Michael S Hansen         
Dep. of Rheumatology, Hvidovre Hospital Recruiting
Copenhagen, Denmark
Sub-Investigator: Merete L Hetland         
Dep. of Radiology, Herlev Hospital Recruiting
Copenhagen, Denmark
Sub-Investigator: Jakob Møller         
Sub-Investigator: Maria Hasselquist         
Dep. of medicine, Herlev Hospital Recruiting
Copenhagen, Denmark
Sub-Investigator: Julia S Johansen         
Dep. of Rheumatologym Glostrup Hospital Recruiting
Copenhagen, Denmark
Sub-Investigator: Mette Klarlund         
Dep. of Rheumatology, Helsinør Hospital Recruiting
Hørsholm, Denmark
Sub-Investigator: Dorte V Jensen         
Dep. of Rheumatology, Køge Hospital Recruiting
Køge, Denmark
Sub-Investigator: Michael Stoltenberg         
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
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
  More Information

No publications provided

Responsible Party: MOstergaard, Professor, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01029847     History of Changes
Other Study ID Numbers: ASIM
Study First Received: December 9, 2009
Last Updated: March 27, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Glostrup University Hospital, Copenhagen:
Patients with axial spondyloarthritis

Additional relevant MeSH terms:
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Bone Diseases, Infectious
Infection
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 15, 2014