| May 23, 2007 |
| August 24, 2009 |
| February 2006 |
| January 2009 (final data collection date for primary outcome measure) |
| Reduction in BASDAI of 20 mm or 50% [ Time Frame: 12-24 weeks of treatment ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00477893 on ClinicalTrials.gov Archive Site |
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| Danish Multicenter Study of Adalimumab in Spondyloarthritis |
| Can New Imaging- and Bio-markers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Spondyloarthritis Patients Receiving Adalimumab |
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. |
See brief summary |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Spondyloarthritis |
- Drug: Adalimumab
- Drug: Placebo
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| Active, not recruiting |
| 52 |
| January 2013 |
| January 2009 (final data collection date for primary outcome measure) |
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
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| Both |
| 18 Years to 90 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Denmark |
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| NCT00477893 |
| Professor Mikkel Østergaard, Dep. of Rheumatology, Hvidovre Hospital |
| HUM 04-078 |
| Hvidovre University Hospital |
| Abbott |
| Study Chair: |
Inge Juul Sørensen, Dr. |
Department of Rheumatology, Hvidovre University Hospital |
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| Study Chair: |
Susanne Juhl Pedersen, Dr. |
Department of Rheumatology, Herlev University Hospital |
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| Principal Investigator: |
Mikkel Ostergaard, Professor |
Department of Rheumatology, Hvidovre University Hospital |
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| Hvidovre University Hospital |
| August 2009 |