A Phase 3 interventional study of Infliximab in Psoriasis and Parapsoriasis, sponsored by Centocor, Inc.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-17.
Sponsored by Centocor, Inc. · Phase 3, Interventional, and Treatment
The purpose of the study is to evaluate the safety and effectiveness of scheduled and as needed treatment of psoriasis with infliximab. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.
This is a phase III, multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled trial evaluating the effectiveness and safety of scheduled and as needed treatment with infliximab in patients with plaque-type psoriasis. This study will also help determine the way to use infliximab in treating patients with psoriasis.
Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures.
Patients will receive infusions of either placebo, 3mg/kg or 5 mg/kg infliximab (Remicade) at weeks 0, 2, 6 14, 18, 22, 26, 30, 34, 38, 42 and 46. Patients receive either 3mg/kg, 5 mg/kg or placebo infusions at week 0, 2, and 6. The 3mg/kg and 5 mg/kg infliximab groups then receive either every 8 week infusions or infusions as needed when their psoriasis is less than 75% improved from baseline. The placebo patients begin infliximab at week 16, 18 and 22 followed by every 8 week infusions.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 683 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Centocor, Inc. is the lead sponsor of 73 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Proportion of patients who achieve greater or equal to 75% improvement in Psoriasis Area and Severity Index (PASI) from baseline at week 10.
Improvement from baseline in Psoriasis Area and Severity Index response between weeks 16 and 30. Change in Dermatology Life Quality Index from baseline at week 10. Patients with a Physician's Global Assessment score of clear or excellent at week 10.
No study locations are listed for this record.
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Centocor, Inc.