A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612)

NCT00687401 | Completed Phase 3 Results DMC

• 1 other identifier: P04612
• Study Type: interventional
• Target: 215
• Locations: 0 countries
• Sites: N/A

Brief Summary

Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic therapy will be eligible to enroll in this study. Subjects will receive infliximab infusions (5 mg/kg of body weight) at Weeks 0, 2, 6, and 14 followed by a 12-week follow-up period. The efficacy of infliximab will be evaluated by the Psoriasis Area and Severity Index (PASI).

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score

  PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).

  10 weeks

Study Arms (1)

Infliximab 5 mg/kg

EXPERIMENTAL

Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6, and 14.

Biological: Infliximab

Interventions

Infliximab BIOLOGICAL

Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).

Also known as: Remicade, SCH 215596

Infliximab 5 mg/kg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=18 to 75 years of age, of either gender, and of any race.
• Psoriasis covering at least 10% of total body surface area (BSA) and PASI \>=12 at Screening and Baseline.
• Diagnosis of moderate-to-severe psoriasis at least 6 months prior the screening.
• Eligible to infliximab who have failed at least 1 of the following: corticosteroids, methotrexate (MTX), systemic retinoids, cyclosporine, psoralen-ultraviolet A (PUVA), ultraviolet B (UVB) phototherapy, and/or biologics (etanercept or efalizumab).
• Eligible according to tuberculosis (TB) eligibility assessment, screening and early detection of reactivation rules.
• Chest x-ray within 3 months prior to Screening with no evidence of malignancy, infection, or fibrosis.
• Screening and Baseline tests (complete blood count \[CBC\], blood chemistry, and urinalysis) must be within protocol-specified parameters.
• Free of significant disease that could interfere with study evaluations.
• Willing to give written informed consent and able to adhere to protocol visits and procedures.
• Women of childbearing potential and all men must be using adequate birth control and must continue to do so for 6 months after receiving the last dose of study medication.
• Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.

You may not qualify if:

• Standard concomitant psoriasis therapies.
• Active or latent TB.
• History of chronic infectious disease, opportunistic infection, or serious infection within 2 months of enrollment.
• History of lymphoproliferative disease.
• Malignancy in past 5 years (except treated basal cell carcinoma \[BCC\]).
• Treatment with tumor necrosis factor (TNF) antagonists within previous 6 weeks.
• Current drug-induced psoriasis.
• Females who are pregnant or nursing and females and males who are planning pregnancy within 6 months from the last infusion of infliximab.
• Previously treated with infliximab.
• Concomitant diagnosis of congestive heart failure (CHF) including medically-controlled asymptomatic subjects.
• History of chronic or recurrent infectious disease.
• Have or have had a serious infection or have been hospitalized or received intravenous antibiotics for an infection during the 2 months prior to Screening.
• Have or have had an opportunistic infection within 6 months prior to Screening.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Centocor, Inc.: collaborator

MeSH Terms

Conditions

Psoriasis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: June 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 11, 2017
• Results First Posted: December 24, 2010

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share