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Sponsors and Collaborators: |
Schering-Plough Essex Pharma GmbH Centocor, Inc. |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00254982 |
This is an open-label, multicenter, parallel-groups comparison study of the efficacy, safety, and tolerability of infliximab therapy in adult patients suffering from chronic plaque psoriasis (psoriasis vulgaris). Patients will be assigned to GROUP I (“high need”) or GROUP II (“low-need”) by the investigator according to their previous psoriasis treatment.
Condition | Intervention | Phase |
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Psoriasis |
Drug: infliximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Study to Determine Equivalence in Efficacy, Organ Safety and Systemic Tolerability Between Infliximab in GROUP I (“High Need”) and GROUP II (“Low Need”) Patients Suffering From Chronic Plaque Psoriasis (Psoriasis Vulgaris) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Study Principal Investigator | Charité Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie |
Study ID Numbers: | P04320, 2005-001243-28 |
Study First Received: | November 15, 2005 |
Last Updated: | February 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00254982 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Anti-Inflammatory Agents Skin Diseases Infliximab |
Psoriasis Antirheumatic Agents Skin Diseases, Papulosquamous |
Anti-Inflammatory Agents Skin Diseases Infliximab Psoriasis Therapeutic Uses |
Gastrointestinal Agents Antirheumatic Agents Dermatologic Agents Skin Diseases, Papulosquamous Pharmacologic Actions |