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


Tracking Information

Start Date  ICMJEOctober 2008
Estimated Primary Completion DateDecember 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: January 29, 2009)		PASI-75 response rate at Week 28. [ Time Frame: At week 28 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00833053 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: January 29, 2009)
  • PASI-50 response, PASI-90 response, PASI-100 response, and raw PASI scores at Week 28. [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
  • Dermatology Life Quality Index and EQ-5D change from Baseline at Week 28 [ Time Frame: Week 0 and Week 28 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEDose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)
Official Title  ICMJEA Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis
Brief Summary

Patients 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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Condition  ICMJEPsoriasis
Intervention  ICMJE
  • Drug: Infliximab
    Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks
    Other Names:
    • Remicade
    • SCH 215596
  • 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
Study Arms / Comparison Groups
  • IFX q 6 weeks: Experimental
    Intervention: Drug: Infliximab
  • IFX + MTX: Experimental
    Intervention: Drug: infliximab and methotrexate

Recruitment Information

Estimated Enrollment  ICMJE200
Estimated Completion DateDecember 2011
Estimated Primary Completion DateDecember 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: SP Clinical Trial Registry Call Center1-888-772-8734
Location Countries  ICMJECanada,   Denmark,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00833053
Responsible PartyHead, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study ID Numbers  ICMJEP05315, EUDRACT: 2008-000454-12
Study Sponsor  ICMJESchering-Plough
Collaborators  ICMJE 
Investigators  ICMJE 
Information Provided BySchering-Plough