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
  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

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10

Secondary Outcome Measures:
  • 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
Detailed Description:

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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230529

Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  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 April 17, 2014