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

This study has been terminated.
(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.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00833053
First received: January 29, 2009
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: Infliximab
Drug: Infliximab and methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28 [ Time Frame: Baseline, Week 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 28 ] [ Designated as safety issue: No ]
    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.


Enrollment: 39
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00833053     History of Changes
Other Study ID Numbers: P05315, EUDRACT: 2008-000454-12
Study First Received: January 29, 2009
Results First Received: March 15, 2012
Last Updated: September 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Infliximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Gastrointestinal Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014