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

Primary Purpose

Psoriasis

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Infliximab
Infliximab and methotrexate
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    IFX q 6 weeks

    IFX + MTX

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    January 29, 2009
    Last Updated
    March 15, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00833053
    Brief Title
    Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)
    Acronym
    DOSE
    Official Title
    A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    In Amendment 1 of P05319 [NCT 00779675], the option to enroll into this study, was discontinued due to low numbers of participants with suboptimal response.
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IFX q 6 weeks
    Arm Type
    Experimental
    Arm Title
    IFX + MTX
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Infliximab
    Other Intervention Name(s)
    Remicade, SCH 215596
    Intervention Description
    Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Infliximab and methotrexate
    Other Intervention Name(s)
    Remicade, SCH 215596
    Intervention Description
    Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly)
    Primary Outcome Measure Information:
    Title
    Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28
    Description
    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.
    Time Frame
    Baseline, Week 28
    Secondary Outcome Measure Information:
    Title
    Number of Participants With A PASI-50 Response at Week 28
    Description
    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.
    Time Frame
    Baseline, Week 28
    Title
    Number of Participants With A PASI-90 Response at Week 28
    Description
    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.
    Time Frame
    Baseline, Week 28
    Title
    Number of Participants With A PASI-100 Response at Week 28
    Description
    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.
    Time Frame
    Baseline, Week 28
    Title
    Change From Baseline in Mean Participant Raw PASI Scores at Week 28
    Description
    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.
    Time Frame
    Baseline, Week 28
    Title
    Dermatology Life Quality Index (DLQI) at Week 28
    Description
    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.
    Time Frame
    Week 28
    Title
    Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28
    Description
    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.
    Time Frame
    Baseline, Week 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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

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

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