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

A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis

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.

Study Overview

• Status: Terminated
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Infliximab; Drug: Infliximab and methotrexate

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IFX q 6 weeks	Drug: Infliximab; Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks; Other Names: Remicade; SCH 215596
Experimental: IFX + MTX	Drug: Infliximab and methotrexate; Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly); Other Names: Remicade; SCH 215596

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With A PASI-50 Response at Week 28	The PASI score 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-50 response indicates the number of participants achieving a 50% reduction compared to baseline in PASI score.	Baseline, Week 28
Number of Participants With A PASI-90 Response at Week 28	The PASI score 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-90 response indicates the number of participants achieving a 90% reduction compared to baseline in PASI score.	Baseline, Week 28
Number of Participants With A PASI-100 Response at Week 28	The PASI score 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-100 response indicates the number of participants achieving a 100% reduction compared to baseline in PASI score.	Baseline, Week 28
Change From Baseline in Mean Participant Raw PASI Scores at Week 28	The PASI score 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.	Baseline, Week 28
Dermatology Life Quality Index (DLQI) at Week 28	The DLQI is a 10-item questionnaire. Scores range from 0-10 with 0 indicating high quality of life and 10 indicating poor quality of life.	Week 28
Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28	The EQ-5D is a descriptive system comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants are asked to indicate his/her health state by selecting the most appropriate statement in each of the 5 dimensions. This selection results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.	Baseline, Week 28

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: January 29, 2009
• First Submitted That Met QC Criteria: January 29, 2009
• First Posted (Estimate): January 30, 2009

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Methotrexate; Infliximab
• Other Study ID Numbers: P05315; EUDRACT: 2008-000454-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php