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Study stopped prior to enrollment.
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Safety and effectiveness, quality of life and work productivity of Humira in patients with psoriatic arthritis in clinical routine.
The primary objective of the Non-Interventional Study is to explore the therapeutic success, measured by improvements in the following target variables (with regard to the respective baseline value):
All of the patient and disease characteristics which are documented at baseline will be evaluated for their additional impact on the target variables (therapeutic success). Particularly the impact of previous biologic therapies on clinical target variables will be evaluated.
The secondary objective is to document the therapeutic success by the following variables:
Target parameters for safety evaluation of adalimumab are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psoriatic arthritis patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab (Humira) | Biological | 40 mg adalimumab (Humira) every other week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in: number of missed working days, self-assessed workability, severity of clinical symptoms and functional impairment, health-related quality of life; safety an tolerability: documentation of adverse events and serious adverse events | Months 0, 3, 6, 12, 24, 36, 48, 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and duration of hospitalization; reduction of number and dose of concomitant medication: patient's assessment of adalimumab therapy compared to previous therapies. | Months 0, 3, 6, 12, 24, 36, 48, 60 |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample: patients with psoriatic arthritis.
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Simianer, MD | Abbott Germany, Medical Department | Study Director |
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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 |