Danish Multicenter Study of Adalimumab in Spondyloarthritis (DANISH)
This study is ongoing, but not recruiting participants.
Sponsor:
Glostrup University Hospital, Copenhagen
Collaborator:
Abbott
Information provided by (Responsible Party):
MOstergaard, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00477893
First received: May 23, 2007
Last updated: March 27, 2012
Last verified: March 2012
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Purpose
Spondyloarthropathies (SpA) are often diagnosed with a considerable delay (often 8-10 years from symptom onset), because the available clinical, biochemical and radiological methods are not sufficiently sensitive. TNF-a antagonists have recently been introduced for treatment of SpA, and current data indicate a higher efficacy than previously available therapies. The improved treatment options have increased the need for improved methods for diagnosis, monitoring and prognostication of these diseases, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.
| 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: | Can New Imaging- and Bio-markers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Spondyloarthritis Patients Receiving Adalimumab |
Resource links provided by NLM:
Further study details as provided by Glostrup University Hospital, Copenhagen:
Primary Outcome Measures:
- Reduction in BASDAI of 20 mm or 50% [ Time Frame: 12-24 weeks of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 52 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2009 (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, 4, 6, 8, and 10.
|
| Active Comparator: Adalimumab |
Drug: Adalimumab
sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study
|
Detailed Description:
See brief summary
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of spondyloarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria
- Clinical active disease, defined as a BASDAI score > 4 despite concurrent NSAID therapy
- Presence of sacroiliitis on conventional radiography or MRI.
- Among other issues: Age >18 years; adequate birth control; no contraindications for anti-TNFa-therapy, no previous TNFa-antagonists
Exclusion Criteria:
- Previous TNFα inhibitor therapy
- Treatment with disease modifying anti-rheumatic drugs within 4 weeks before screening
- Oral, intraarticular, intramuscular or intravenous glucocorticoid within 4 weeks before screening
- Pregnancy or lactation
- HIV, hepatitis B or C, tuberculosis, other infections
- Malignancies
- Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral disease (including demyelinating disease)
- Contraindications to anti-TNFa-therapy
- Contraindications to MRI
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477893
Locations
| Denmark | |
| Department of Radiology, Aabenraa Hospital | |
| Aabenraa, Denmark | |
| Department of Rheumatology, Bispebjerg University Hospital | |
| Copenhagen, Denmark | |
| Department of Rheumatology, Hvidovre University Hospital | |
| Copenhagen, Denmark | |
| Department of Radiology, Herlev University Hospital | |
| Copenhagen, Denmark | |
| Department of Rheumatology, Herlev University Hospital | |
| Copenhagen, Denmark | |
| Department of Rheumatology, Gentofte University Hospital | |
| Copenhagen, Denmark | |
| Department of Rheumatology, Glostrup University Hospital | |
| Copenhagen, Denmark | |
| King Christian X´s Hospital of Rheumatic Diseases | |
| Graasten, Denmark | |
| Department of Rheumatology, Hørsholm Hospital | |
| Hørsholm, Denmark | |
| Department of Rheumatology, Slagelse Hospital | |
| Slagelse, Denmark | |
| Department of Radiology, Vejle Hospital, | |
| Vejle, Denmark | |
| Department of Rheumatology, Vejle Hospital | |
| Vejle, Denmark | |
| Department of Radiology, Århus University Hospital | |
| Århus, Denmark | |
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Abbott
Investigators
| Study Chair: | Inge Juul Sørensen, Dr. | Department of Rheumatology, Glostrup University Hospital |
| Study Chair: | Susanne Juhl Pedersen, Dr. | Department of Rheumatology, Glostrup University Hospital |
| Principal Investigator: | Mikkel Ostergaard, Professor | Department of Rheumatology, Glostrup University Hospital |
More Information
No publications provided
| Responsible Party: | MOstergaard, Professor, Glostrup University Hospital, Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00477893 History of Changes |
| Other Study ID Numbers: | HUM 04-078 |
| Study First Received: | May 23, 2007 |
| Last Updated: | March 27, 2012 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: Danish Medicines Agency |
Additional relevant MeSH terms:
|
Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Musculoskeletal Diseases Arthritis |
Joint Diseases Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 19, 2013