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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000004-16 | EudraCT Number |
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| Name | Class |
|---|---|
| University Hospital, Gentofte, Copenhagen | OTHER |
| Copenhagen University Hospital at Herlev | OTHER |
| Copenhagen University Hospital, Hvidovre | OTHER |
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Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, which has a estimated prevalence of 0.3 - 1 %. The clinical course varies, but PsA is often a progressive, erosive arthritis causing severe disability and increased mortality.
The biologic treatment infliximab and etanercept have recently been introduced for treatment of PsA and psoriasis, and current data indicate a higher efficacy than with previously available therapies. No clinical trials on adalimumab in PsA are yet published (2005), but preliminary data are encouraging. The improved treatment options have increased the need for sensitive methods for diagnosis, monitoring and prognostication of PsA, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Ultrasonography (US) and magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.
The hypothesis is that adalimumab will be an effective treatment option for PsA. Novel imaging- and biomarkers can provide additional information, compared to clinical measures and radiography, concerning activity, destructive progression and prediction of therapeutic response in PsA patients receiving adalimumab. The perspective is a potential improvement in diagnosis, monitoring and prognostication of patients with PsA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Experimental | Responders at week 24 continue treatment with adalimumab. Non-responders at week 24 stops treatment with adalimumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | Adalimumab 40 mg every other week |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Modified Psoriatic Arthritis Response criteria (PsARC) | 24 weeks |
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Inclusion Criteria:
Subject Population: patients with active PsA, fulfilling the following major criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlotte Wiell, MD, PhD | University Hospital, Gentofte, Copenhagen | Study Chair |
| Inge Juul Sørensen, MD, PhD | Copenhagen University Hospital, Hvidovre | Principal Investigator |
| Michael Sejer Hansen, MD, PhD | Copenhagen University Hospital at Herlev | Principal Investigator |
| Ole Rintek Madsen, MD, PhD | University Hospital, Gentofte, Copenhagen | Principal Investigator |
| Ole Slot, MD | Glostrup University Hospital, Copenhagen | Principal Investigator |
| Susanne J Pedersen, MD | Gentofte University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Glostrup | Glostrup Municipality | Copenhagen | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24369412 | Derived | Poggenborg RP, Wiell C, Boyesen P, Boonen A, Bird P, Pedersen SJ, Sorensen IJ, Madsen OR, Slot O, Moller JM, Hasselquist M, Kubassova O, Ostergaard M. No overall damage progression despite persistent inflammation in adalimumab-treated psoriatic arthritis patients: results from an investigator-initiated 48-week comparative magnetic resonance imaging, computed tomography and radiography trial. Rheumatology (Oxford). 2014 Apr;53(4):746-56. doi: 10.1093/rheumatology/ket426. Epub 2013 Dec 24. |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal 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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| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |