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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Psoriasis

Treatments: Biological: Infliximab

Study type: Observational

Funder types: Industry

Identifiers

NCT00779675

P05319

MK-2155-139 (Other Identifier)

Details and patient eligibility

About

This is a prospective Phase 4, open-label, non-randomized, observational, multi-center study of infliximab in participants 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.

Full description

This study will be conducted in two phases: the 50-week treatment period and the 48-week extended treatment period.

Enrollment: 660 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must have a diagnosis of plaque-type psoriasis
• Participant's physician must have decided, with the subject's consent, to start treatment with infliximab
• Participant must demonstrate willingness to participate in the study and agree with the procedures of the study by signing the written informed consent
• For inclusion into the extended treatment period, participant must have completed 50 weeks of infliximab treatment in the treatment period
• For inclusion into the extended treatment period, participant must be continuing treatment with intravenous infliximab
• For inclusion into the extended treatment period, participant must have an improvement in their PASI score of greater than or equal to 25% at the time of entry into to the extended treatment period

Exclusion criteria

For the Treatment Period

• Given the non-interventional nature of the study, no specific exclusion criteria will be applied to a participant so long as the participant 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

For the Extended Treatment Period

• Given the non-interventional nature of the study, no specific exclusion criteria will be applied to a participant so long as the participant is receiving infliximab treatment in accordance with the PM (Canada), the approved SPC (EU), or local labeling (for all other participating countries) regarding contraindications, precautions, dosing and frequency of administration

Trial design

660 participants in 1 patient group

Infliximab 5 mg/kg

Treatment:

Biological: Infliximab