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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.
Spondyloarthritis
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Drug: Adalimumab
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Phase IV
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U.S. FDA Resources
| Study Type: |
Interventional |
| Study Design: |
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
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| 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 |
| Study Start Date: |
February 2006 |
| Estimated Study Completion Date: |
August 2008 |
| Ages Eligible for Study: |
18 Years to 90 Years |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
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 TNF%u03B1 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477893
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| King Christian X´s Hospital of Rheumatic Diseases |
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| Graasten, Denmark |
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| Contact: Lis S Andersen, dr. |
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| Department of Rheumatology, Bispebjerg University Hospital |
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| Copenhagen, Denmark |
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| Contact: Karsten Asmussen, Dr. |
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| Department of Rheumatology, Hvidovre University Hospital |
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| Copenhagen, Denmark |
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| Contact: Inge Juul Sørensen, Dr. |
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| Department of Rheumatology, Hørsholm Hospital |
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| Hørsholm, Denmark |
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| Contact: Jesper Nørregaard, Dr. |
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| Department of Rheumatology, Herlev University Hospital |
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| Copenhagen, Denmark |
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| Contact: Michael Sejer Hansen, Dr. |
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| Department of Rheumatology, Gentofte University Hospital |
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| Copenhagen, Denmark |
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| Contact: Hanne Slott Jensen, Dr. |
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| Department of Radiology, Vejle Hospital, |
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| Vejle, Denmark |
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| Contact: Thomas Skjødt, Dr. |
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| Department of Rheumatology, Glostrup University Hospital |
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| Copenhagen, Denmark |
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| Contact: Gorm Thamsborg, Dr. |
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| Department of Rheumatology, Slagelse Hospital |
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| Slagelse, Denmark |
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| Contact: Torben Grube Christensen, Dr. |
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| Department of Radiology, Herlev University Hospital |
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| Copenhagen, Denmark |
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| Contact: Maria Hasselquist, Dr. |
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| Department of Radiology, Århus University Hospital |
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| Århus, Denmark |
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| Contact: Anne Grethe Jurik, Dr. |
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| Department of Radiology, Aabenraa Hospital |
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| Aabenraa, Denmark |
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| Contact: Dorrit Mikkelsen, Dr. |
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| Department of Rheumatology, Vejle Hospital |
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| Vejle, Denmark |
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| Contact: Anne Gitte Loft, Dr. |
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| Hvidovre University Hospital |
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| Abbott |
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| 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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| King Christian X´s Hospital of Rheumatic Diseases |
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| Graasten, Denmark |
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| Contact: Lis S Andersen, dr. |
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| Department of Rheumatology, Bispebjerg University Hospital |
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| Copenhagen, Denmark |
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| Contact: Karsten Asmussen, Dr. |
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| Department of Rheumatology, Hvidovre University Hospital |
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| Copenhagen, Denmark |
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| Contact: Inge Juul Sørensen, Dr. |
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| Department of Rheumatology, Hørsholm Hospital |
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| Hørsholm, Denmark |
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| Contact: Jesper Nørregaard, Dr. |
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| Department of Rheumatology, Herlev University Hospital |
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| Copenhagen, Denmark |
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| Contact: Michael Sejer Hansen, Dr. |
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| Department of Rheumatology, Gentofte University Hospital |
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|
| Copenhagen, Denmark |
|
| Contact: Hanne Slott Jensen, Dr. |
|
| Department of Radiology, Vejle Hospital, |
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| Vejle, Denmark |
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| Contact: Thomas Skjødt, Dr. |
|
| Department of Rheumatology, Glostrup University Hospital |
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|
| Copenhagen, Denmark |
|
| Contact: Gorm Thamsborg, Dr. |
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| Department of Rheumatology, Slagelse Hospital |
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| Slagelse, Denmark |
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| Contact: Torben Grube Christensen, Dr. |
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| Department of Radiology, Herlev University Hospital |
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| Copenhagen, Denmark |
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| Contact: Maria Hasselquist, Dr. |
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| Department of Radiology, Århus University Hospital |
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| Århus, Denmark |
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| Contact: Anne Grethe Jurik, Dr. |
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| Department of Radiology, Aabenraa Hospital |
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| Aabenraa, Denmark |
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| Contact: Dorrit Mikkelsen, Dr. |
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| Department of Rheumatology, Vejle Hospital |
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| Vejle, Denmark |
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| Contact: Anne Gitte Loft, Dr. |
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| Hvidovre University Hospital |
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| Abbott |
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| 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 |
| Study ID Numbers: |
HUM 04-078 |
| First Received: |
May 23, 2007 |
| Last Updated: |
May 23, 2007 |
| ClinicalTrials.gov Identifier: |
NCT00477893 |
| Health Authority: |
Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Medicines Agency |
Study placed in the following topic categories:
| Spinal Diseases |
| Musculoskeletal Diseases |
| Joint Diseases |
| Arthritis | |
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| Disease Progression |
| Adalimumab |
| Bone Diseases |
| Spondylarthritis | | Additional relevant MeSH terms:
| Anti-Inflammatory Agents |
| Spondylarthritis |
| Therapeutic Uses |
| Antirheumatic Agents |
| Pharmacologic Actions | |
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