Assessment of Long-Term Infliximab for Psoriasis (P05319)

NCT ID: NCT00779675

Last Updated: 2015-11-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 660 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-08-31

Brief Summary

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.

Detailed Description

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

Conditions

Psoriasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Infliximab 5 mg/kg

Infliximab

Intervention Type: BIOLOGICAL

Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).

Interventions

Infliximab

Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).

Intervention Type: BIOLOGICAL

Other Intervention Names

Remicade; SCH 215596

Eligibility Criteria

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

For the Extended Treatment Period

Exclusion Criteria

For the Treatment Period

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Shear NH, Hartmann M, Toledo-Bahena M, Katsambas A, Connors L, Chang Q, Yao R, Nograles K, Popmihajlov Z; REALITY investigators. Long-term efficacy and safety of infliximab maintenance therapy in patients with plaque-type psoriasis in real-world practice. Br J Dermatol. 2014 Sep;171(3):631-41. doi: 10.1111/bjd.13004. Epub 2014 Aug 13.

Reference Type: RESULT

PMID: 24673357 (View on PubMed)

Other Identifiers

MK-2155-139

Identifier Type: OTHER

Identifier Source: secondary_id

P05319

Identifier Type: -

Identifier Source: org_study_id