Assessment of Long-Term Infliximab for Psoriasis (Study P05319) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00779675

Purpose

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.

Condition	Intervention
Psoriasis	Biological: Infliximab

MedlinePlus related topics: Psoriasis

Drug Information available for: Infliximab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Real-World Assessment of Long-Term Infliximab Therapy for Psoriasis

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Remicade 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.	Biological: 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.

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

A subject with psoriasis whom the physician has chosen to treat with infliximab in accordance with local clinical practices will be advised about this trial.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779675

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Netherlands
Investigational Site 1	Recruiting
Alkmaar, Netherlands, 1815 KX

Sponsors and Collaborators

Schering-Plough

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05319
Study First Received:	October 23, 2008
Last Updated:	December 14, 2008
ClinicalTrials.gov Identifier:	NCT00779675
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Skin Diseases
Infliximab
Psoriasis
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Gastrointestinal Agents

Antirheumatic Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009