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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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.
See brief summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Adalimumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | sc. injection Humira 40 mg every other week, from week 0 or 12 to the end of study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in BASDAI of 20 mm or 50% | 12-24 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inge Juul Sørensen, Dr. | Department of Rheumatology, Glostrup University Hospital | Study Chair |
| Susanne Juhl Pedersen, Dr. | Department of Rheumatology, Glostrup University Hospital | Study Chair |
| Mikkel Ostergaard, Professor | Department of Rheumatology, Glostrup University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiology, Aabenraa Hospital | Aabenraa | Denmark | ||||
| Department of Radiology, Århus University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26414004 | Derived | Pedersen SJ, Poddubnyy D, Sorensen IJ, Loft AG, Hindrup JS, Thamsborg G, Asmussen K, Hendricks O, Norregaard J, Piil AD, Moller JM, Jurik AG, Balding L, Lambert RG, Sieper J, Ostergaard M. Course of Magnetic Resonance Imaging-Detected Inflammation and Structural Lesions in the Sacroiliac Joints of Patients in the Randomized, Double-Blind, Placebo-Controlled Danish Multicenter Study of Adalimumab in Spondyloarthritis, as Assessed by the Berlin and Spondyloarthritis Research Consortium of Canada Methods. Arthritis Rheumatol. 2016 Feb;68(2):418-29. doi: 10.1002/art.39434. |
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| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Placebo | Drug | sc. inj. placebo every other week, week 0, 2, 4, 6, 8, and 10. |
|
| Aarhus |
| Denmark |
| Department of Radiology, Herlev University Hospital | Copenhagen | Denmark |
| Department of Rheumatology, Bispebjerg University Hospital | Copenhagen | Denmark |
| Department of Rheumatology, Gentofte University Hospital | Copenhagen | Denmark |
| Department of Rheumatology, Glostrup University Hospital | Copenhagen | Denmark |
| Department of Rheumatology, Herlev University Hospital | Copenhagen | Denmark |
| Department of Rheumatology, Hvidovre University Hospital | Copenhagen | Denmark |
| King Christian X´s Hospital of Rheumatic Diseases | Gråsten | 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 |
| D001168 |
| Arthritis |
| D007592 | Joint Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |