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

NCT ID: NCT00833053

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IFX q 6 weeks

Group Type: EXPERIMENTAL

Infliximab

Intervention Type: DRUG

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

IFX + MTX

Group Type: EXPERIMENTAL

Infliximab and methotrexate

Intervention Type: DRUG

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

Interventions

Infliximab

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

Intervention Type: DRUG

Infliximab and methotrexate

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

Intervention Type: DRUG

Other Intervention Names

Remicade; SCH 215596; Remicade; SCH 215596

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EUDRACT: 2008-000454-12

Identifier Type: -

Identifier Source: secondary_id

P05315

Identifier Type: -

Identifier Source: org_study_id