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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00705289 |
This 14-week non-interventional study will observe patients with rheumatoid arthritis (RA) who are being treated with infliximab for the first time, in order to learn about their disease characteristics. Patients in this study will be treated for RA with infliximab and in a usual manner as decided by their physician.
Condition | Intervention |
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Rheumatoid Arthritis |
Biological: Infliximab |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Epidemiology, Correlation and Predictive Value of Disease Activity and Biomarkers in RA Patients Initiated on Infliximab in Clinical Practice |
Blood and Urine samples
Enrollment: | 694 |
Study Start Date: | November 2005 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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RA Subjects
Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
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Biological: Infliximab
Infliximab used in line with current clinical practice and local guidelines.
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Subjects will be patients with rheumatoid arthritis in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European SPC of Remicade®).
Subjects will be recruited from approximately 11 countries, including: Austria, Belgium, Denmark, , Greece, Netherlands, Norway, Poland, Portugal, Sweden, Switzerland and Turkey.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04250 |
Study First Received: | June 23, 2008 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00705289 |
Health Authority: | United States: Institutional Review Board |
Autoimmune Diseases Musculoskeletal Diseases Infliximab Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Anti-Inflammatory Agents Immune System Diseases Therapeutic Uses Gastrointestinal Agents |
Antirheumatic Agents Dermatologic Agents Pharmacologic Actions |