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A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00230529
First received: September 29, 2005
Last updated: June 8, 2011
Last verified: August 2010

September 29, 2005
June 8, 2011
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Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10
Proportion of patients achieving a ≥ 75% improvement in PASI score from baseline at week 10
Complete list of historical versions of study NCT00230529 on ClinicalTrials.gov Archive Site
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
  • 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 status of antibodies to infliximab at week 26
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A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis
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

The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with plaque-type psoriasis.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Psoriasis
Drug: infliximab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
January 2003
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00230529
CR003124
Not Provided
Not Provided
Centocor, Inc.
Not Provided
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP