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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00358670 |
This is a long-term, randomized, multi-center, open-label study of infliximab treatment in adults with moderate to severe plaque-type psoriasis. This study is the long-term extension of Study P04271; Study P04271 is a Phase 3b, randomized, parallel-group, multicenter, open-label, 26-week study comparing the efficacy and safety of infliximab versus methotrexate in the treatment of adult subjects with moderate to severe plaque-type psoriasis.
The objectives of this study are to assess the efficacy and safety of long-term maintenance therapy versus intermittent therapy with 5 mg/kg infliximab in a moderate to severe plaque-type psoriasis population.
During an interim safety evaluation of the trial, a higher incidence of serious and severe infusion reactions was observed in the intermittent treatment arm, consisting of a re-induction cycle (maximum of 4 infusions at 0, 2, 6 and 14 weeks) after a period of no treatment compared with the maintenance arm (infusions every 8 weeks without an interruption of treatment). Consequently, the sponsor has terminated the trial. The label will be updated to reflect this new information relating to the use of a re-induction regimen with infliximab.
Condition | Intervention | Phase |
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Psoriasis |
Biological: infliximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Long-Term Efficacy and Safety Study of Infliximab in the Treatment of Moderate to Severe Plaque-Type Psoriasis |
Enrollment: | 442 |
Study Start Date: | May 2006 |
Study Completion Date: | January 2009 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Maintenance Infliximab: Experimental
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Biological: infliximab
Infliximab maintenance therapy IV Infusion every 8 weeks, 5 mg/kg body weight (first infusion at Week 4/Visit 2).
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Intermittent Infliximab: Experimental
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Biological: infliximab
Infliximab intermittent therapy: Subjects will receive no infliximab treatment until the Week 26 improvement in PASI from Baseline (original Study P04271 Baseline) is reduced by more than 50%. At that time, subjects will receive an infliximab infusion, 5 mg/kg body weight. Subjects may receive additional infusions at 0, 2, 6, and 14 weeks after the first infusion of the cycle (ie, a maximum of 4 infusions in each infusion cycle) as needed until they respond, defined as a >=75% improvement in PASI from the original Baseline in Study P04271. Subjects will receive no further treatment until they relapse again (ie, improvement in PASI from Baseline is reduced by more than 50%), at which time subjects will receive another infusion cycle of up to 4 infusions, as described above. Throughout the study, intermittent treatment infusion cycles will be repeated whenever subjects relapse. |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects are considered eligible according to the following tuberculosis (TB) criteria:
Subjects' Baseline (Visit 1) clinical laboratory tests (CBC, blood chemistry, and urinalysis) must be within the following parameters:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04563, EUDRACT NUMBER:2005-005367-28 |
Study First Received: | July 31, 2006 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00358670 History of Changes |
Health Authority: | Austria: Federal Ministry for Health and Women |
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 |