Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)

NCT00833053 | Terminated Phase 3 Results

• 2 other identifiers: P05315EUDRACT: 2008-000454-12
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28

  The Psoriasis Area and Sensitivity Index (PASI) is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.

  Baseline, Week 28

Secondary Outcomes (6)

• Number of Participants With A PASI-50 Response at Week 28

  Baseline, Week 28

• Number of Participants With A PASI-90 Response at Week 28

  Baseline, Week 28

• Number of Participants With A PASI-100 Response at Week 28

  Baseline, Week 28

• Change From Baseline in Mean Participant Raw PASI Scores at Week 28

  Baseline, Week 28

• Dermatology Life Quality Index (DLQI) at Week 28

  Week 28

Study Arms (2)

IFX q 6 weeks

EXPERIMENTAL

Drug: Infliximab

IFX + MTX

EXPERIMENTAL

Drug: Infliximab and methotrexate

Interventions

Infliximab DRUG

Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks

Also known as: Remicade, SCH 215596

IFX q 6 weeks

Infliximab and methotrexate DRUG

Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly)

Also known as: Remicade, SCH 215596

IFX + MTX

Eligibility Criteria

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

You may qualify if:

• Subjects must have a diagnosis of moderate to severe plaque-type psoriasis and have had participated in Study P05319.
• Subjects must have demonstrated an adequate but suboptimal response to infliximab in Study P05319
• Subjects must be at least 18 years old
• Subjects must be candidates for phototherapy or systemic treatment for psoriasis.
• Subjects must not be pregnant and must meet contraceptive requirements
• Subjects must meet tuberculosis screening criteria
• Subjects must meet laboratory and medical history screening requirements

You may not qualify if:

• Subjects for whom infliximab or methotrexate is contraindicated or not recommended.
• Subjects already using certain investigational, biological, or immunosuppressive drugs
• Subjects with certain comorbid conditions
• Subjects who currently have or have a history of certain infections
• Subjects who have recently received live virus or bacterial vaccinations
• Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Psoriasis

Interventions

Infliximab; Methotrexate

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; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: January 30, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 12, 2017
• Results First Posted: July 26, 2012

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share