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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016587-36 | EudraCT Number |
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No patient enrolled after 6 months from the start. The decision to withdraw the study was based on a feasibility reevaluation conducted with investigators.
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| Name | Class |
|---|---|
| Hospital Universitario Reina Sofia de Cordoba | OTHER_GOV |
| Dr. Jose MarÃa Martos Becerra (Central Radiological Assessment) - Hospital de Alta Resolución, Puente Genil (Spain) | UNKNOWN |
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This trial is designed to measure improvement of hip involvement in patients with ankylosing spondylitis (AS) after receiving 4 doses of infliximab. Participants will receive infliximab 5 mg/kg (as an intravenous perfusion over a period of 2 hours) at Weeks 0, 2, 6, and 14, consistent with the approved dosing regimen described in the label. Participants will be evaluated for hip pain, functional capacity and stiffness before and after 14 weeks (4 doses) of treatment. Further treatment after 4 doses is based on standard clinical practice as determined by the trial site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remicade | Experimental | Infliximab 5 mg/kg was administered as specified in the Summary of Product Characteristics for patients with ankylosing spondylitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Infliximab 5 mg/kg administered as an intravenous perfusion over a period of 2 hours at Weeks 0, 2, 6, and 14, as indicated in the Summary of Product Characteristics |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with clinical improvement assessed by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire | Baseline and Week 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |