A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis
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Purpose
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with plaque-type psoriasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: infliximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of Infliximab (REMICADE�) Induction Therapy in Patients With Plaque-type Psoriasis |
- Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10
- The proportion of patients positive for antibodies to infliximab;The proportion of patients with infusion reactions at week 26;The proportion of infliximab-treated patients with infusion reaction at week 26 by antibodies to infliximab status at week 26
| Enrollment: | 249 |
| Study Completion Date: | January 2003 |
The purpose of this study is to investigate the safety and possible usefulness of infliximab therapy for patients with severe plaque psoriasis. In a previous small study of infliximab in 33 patients with psoriasis, about 80% of patients treated with infliximab showed improvement in their psoriasis symptoms after the first 3 infusions, while 20% of patients who received placebo showed improvement. The patients will receive infusions of infliximab either 3 or 5 mg/kg or placebo at weeks 0,2,6. Patients who have significant psoriasis at week 26 will receive an additional infusion.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must be 18 years of age or older at time of enrollment
- may be male or female
- Have had a diagnosis of plaque-type psoriasis at least 6 months prior to screening
- Have plaque-type psoriasis covering at least 10% of total BSA at baseline
- Have previously received PUVA and/or other systemic treatment for psoriasis
Exclusion Criteria:
- Have non-plaque forms of psoriasis
- Have a history of drug-induced psoriasis
- Are pregnant, nursing, or planning pregnancy within 12 months of enrollment
- Have had any previous treatment with infliximab or any therapeutic agent
Contacts and Locations More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00230529 History of Changes |
| Obsolete Identifiers: | NCT01128491 |
| Other Study ID Numbers: | CR003124 |
| Study First Received: | September 29, 2005 |
| Last Updated: | June 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Centocor, Inc.:
|
Plaque-type Psoriasis infliximab Remicade biologics |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Infliximab Dermatologic Agents |
Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013