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

Study Overview
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Brief Summary
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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.

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

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Infliximab
* Drug: Infliximab and methotrexate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |