Study to Evaluate the Efficacy of Infliximab Induction Therapy for Patients With Palmoplantar Psoriasis (PPP)(Study P04555)(COMPLETED)

NCT00686686 | Completed Phase 3 Results

• 1 other identifier: P04555
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

Subjects with psoriasis will receive intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 (induction therapy) to evaluate the efficacy of infliximab at Week 18. Subjects who achieved \>=75% improvement in Psoriasis Pustulosa Palmoplantaris Area and Severity Index (PPPASI) score at Week 8 AND had deterioration of PPPASI score of 50% from Week 8 until Week 12 were to receive an additional infusion at Week 12.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieve at Least 75% Improvement in Palmoplantar Psoriasis Activity Severity Index (PPPASI) After 3 Infusions.

  The PPPASI score is an overall score of disease signs: extent, scales, erythema, erosions (fissures), induration and pustules. "Extent" is rated on a scale range from 0-6; all other signs are rated on a scale range from 0 to 4 in a target palm and/or sole. Total score range:0-26. A reduction in score is considered an improvement.

  Baseline and Week 8

Secondary Outcomes (4)

• Number of Participants Who Achieve a Moderate Response.

  Baseline and Week 8

• Number of Participants Achieving Clear to Minimal PGA Score at Weeks 12 and 18.

  Weeks 12 and 18

• Number of Participants Who Respond to the Fourth Infusion.

  Week 12 and Week 18

• Dermatology Life Quality Index (DLQI)

  Baseline and Week 12

Study Arms (1)

Infliximab 5 mg/kg

EXPERIMENTAL

Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.

Biological: Infliximab

Interventions

Infliximab BIOLOGICAL

Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.

Also known as: SCH 215596, Remicade

Infliximab 5 mg/kg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age at time of enrollment; male or female.
• Women of childbearing potential and all men must be using adequate birth control measures and should continue using such measures until 6 months after receiving the last infusion of study agent.
• Plaque-type psoriasis with evidence of mild to moderate psoriasis elsewhere or Psoriasis Pustulosa Palmo Plantaris (PPPP) of 6 months duration at least.
• Adhere to study visit schedule and other protocol requirements.
• Capable of giving informed consent prior to any study related procedures.
• Avoid prolonged sun exposure, including tanning booths or other ultraviolet (UV) light sources during the study.
• Eligible according to country-specific tuberculosis (TB) screening, eligibility assessment, and prevention rules.
• Chest x-ray within 3 months prior to first infusion with no evidence of malignancy, infection, or fibrosis.
• Screening laboratory test results within parameters specified in protocol.

You may not qualify if:

• Have any other form of psoriasis besides palmoplantaris and the pustular form.
• Pregnant, nursing, or planning pregnancy within 6 months after last infusion.
• Previous treatment with infliximab or any therapeutic agent targeted at reducing tumor-necrosis factor (TNF), including but not limited to etanercept, thalidomide, CDP870, or D2E7.
• Other inflammatory disease that might confound the evaluations of benefit from the infliximab therapy, including but not limited to, rheumatoid arthritis (RA), ankylosing spondylitis, systemic lupus erythematosus, Lyme disease.
• Used any investigational drug within the previous 1 month or 5 times the half life of the investigational agent, whichever is longer, or 3 months for any biologic of unknown half life.
• Received any systemic medications/treatments that could affect psoriasis or PASI evaluation within 1 month prior to study.
• Used topical medications/treatments that could affect psoriasis or PASI evaluation within 2 or 4 weeks of baseline visit.
• Treated with any anti-CD4 antibody in the last 6 month.
• Received any systemic immunosuppressive within 4 weeks prior to first infusion.
• Received within 3 months prior to first infusion or are expected to receive any live virus or bacterial vaccinations during the trial or up to 3 months after the last infusion.
• History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection, or open, draining or infected skin wounds or ulcers.
• Serious infection or been hospitalized or received IV antibiotics for an infection during the previous 2 months.
• Have or had opportunistic infection.
• Herpes zoster infection within 2 months of baseline.
• Infected with human immunodeficiency virus (HIV), hepatitis B or C.

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: NON RANDOMIZED
• 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: December 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 11, 2017
• Results First Posted: February 23, 2011

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share