Assessment of Long-Term Infliximab for Psoriasis (Study P05319) (REALITY)


Tracking Information

Start Date  ICMJEOctober 2008
Estimated Primary Completion DateJune 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: October 23, 2008)		The proportion of subjects with a PASI-75 response (change in PASI of >=75% from Baseline) at Week 50. [ Time Frame: Week 50 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00779675 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: October 23, 2008)
  • Baseline characteristics by PASI 75 response [ Time Frame: Week 50 ] [ Designated as safety issue: No ]
  • The proportion of subjects with PASI 75 response. [ Time Frame: Week 50 ] [ Designated as safety issue: No ]
  • The proportion of subjects with PASI-90 response. [ Time Frame: Week 50 ] [ Designated as safety issue: No ]
  • The proportion of subjects with PASI 100 response. [ Time Frame: Week 50 ] [ Designated as safety issue: No ]
  • The subjects' raw PASI scores at Visit 2/Week 14. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • The subjects' raw PASI scores at Visit 3/Week 30 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
  • The subjects' raw PASI scores at Visit 4/Week 50 (Follow Up). [ Time Frame: Week 50 ] [ Designated as safety issue: No ]
  • DLQI to assess quality of life [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • DLQI to assess quality of life [ Time Frame: Week 50 or early termination ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEAssessment of Long-Term Infliximab for Psoriasis (Study P05319)
Official Title  ICMJEReal-World Assessment of Long-Term Infliximab Therapy for Psoriasis
Brief Summary

This is a prospective Phase 4, open-label, non-randomized, observational, multi-center study of infliximab in subjects with plaque-type psoriasis to assess the clinical response in real-world practice of long-term maintenance therapy with infliximab 5 mg/kg body weight in a psoriasis population, prescribed in a regimen in accordance with the product monograph (PM) for Canada, the approved summary sheet of product characteristics (SPC) for countries in the European Union (EU), or per label according to local guidelines for all other participating countries.

Detailed Description

The population in this study was chosen using a non-probability sampling method.

Study Phase 
Study Type  ICMJEObservational
Study Design  ICMJECohort, Prospective
Condition  ICMJEPsoriasis
Intervention  ICMJEBiological: Infliximab
To assess the clinical response in real-world practice of long-term maintenance therapy with infliximab 5 mg/kg body weight in a psoriasis population, prescribed in a regimen in accordance with the PM for Canada, the approved SPC for countries in the EU, or per label according to local guidelines for all other participating countries.
Other Names:
  • Remicade
  • SCH 215596
Study Arms / Comparison GroupsRemicade
The studied population will be comprised of subjects with a physician's diagnosis of plaque-type psoriasis. It is highly recommended that 30% of the subjects enrolled be naïve to previous biologic therapy. For example, if a site recruits 10 subjects, 3 out of these 10 subjects should be naïve to previous biologic therapy.
Intervention: Biological: Infliximab

Recruitment Information

Estimated Enrollment  ICMJE1000
Estimated Completion DateJune 2011
Estimated Primary Completion DateJune 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must have a diagnosis of plaque-type psoriasis,
  • Subject's physician must have decided, with the subject's consent, to start treatment with infliximab,
  • Subject must be at least 18 years of age, of either sex,
  • Subject must demonstrate willingness to participate in the study and agree with the procedures of the study by signing the written informed consent.

Exclusion Criteria:

Given the non-interventional nature of the study, no specific exclusion criteria will be applied to a subject so long as the subject is eligible for the trial (Inclusion Criteria). The treating physician is expected, as in normal clinical practice, to follow the PM (Canada), the approved SPC (EU), or local labeling (for all other participating countries) regarding contraindications and precautions.

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

Administrative Information

NCT ID  ICMJENCT00779675
Responsible PartyHead, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study ID Numbers  ICMJEP05319
Study Sponsor  ICMJESchering-Plough
Collaborators  ICMJE 
Investigators  ICMJE 
Information Provided BySchering-Plough