Adalimumab in Axial Spondyloarthritis (ASIM) - MRI and Biomarkers in Patients With Spondyloarthritis
This study is currently recruiting participants.
Verified March 2012 by Glostrup University Hospital, Copenhagen
Sponsor:
Glostrup University Hospital, Copenhagen
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
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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 May 23, 2013