NCT00230529

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2005

Completed
Last Updated

June 9, 2011

Status Verified

August 1, 2010

First QC Date

September 29, 2005

Last Update Submit

June 8, 2011

Conditions

Psoriasis

Keywords

Plaque-type PsoriasisinfliximabRemicadebiologics

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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

Interventions

infliximabDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Gottlieb AB, Evans R, Li S, Dooley LT, Guzzo CA, Baker D, Bala M, Marano CW, Menter A. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2004 Oct;51(4):534-42. doi: 10.1016/j.jaad.2004.02.021.

    PMID: 15389187RESULT

  • Feldman SR, Gordon KB, Bala M, Evans R, Li S, Dooley LT, Guzzo C, Patel K, Menter A, Gottlieb AB. Infliximab treatment results in significant improvement in the quality of life of patients with severe psoriasis: a double-blind placebo-controlled trial. Br J Dermatol. 2005 May;152(5):954-60. doi: 10.1111/j.1365-2133.2005.06510.x.

    PMID: 15888152RESULT

Related Links

MeSH Terms

Conditions

Psoriasis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 29, 2005

First Posted

October 3, 2005

Study Completion

January 1, 2003

Last Updated

June 9, 2011

Record last verified: 2010-08