Assessment of Long-Term Infliximab for Psoriasis (P05319)

NCT00779675 | Completed Results

• 2 other identifiers: P05319MK-2155-139
• Study Type: observational
• Target: 660
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50

  Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as \>=75% improvement in overall PASI score when compared to baseline.

  Week 50

Secondary Outcomes (15)

• Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14

  Week 50

• Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14

  Week 50

• Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14

  Week 50

• Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period

  Week 98

• Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period

  Week 98

Study Arms (1)

Infliximab 5 mg/kg

Biological: Infliximab

Interventions

Infliximab 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).

Also known as: Remicade, SCH 215596

Infliximab 5 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with plaque-type psoriasis in which the treating physician has selected for treatment with infliximab, in accordance with local clinical practices, will be advised about this trial. It is highly recommended that 30% of the participants enrolled be naïve to previous biologic therapy. For example, if a site recruits 10 participants, 3 out of these 10 participants should be naïve to previous biologic therapy.

You may qualify if:

• 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

You may not qualify if:

• For the Treatment Period
• For the Extended Treatment Period

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 24673357 RESULT

MeSH Terms

Conditions

Psoriasis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: August 1, 2012
• Last Updated: November 2, 2015
• Results First Posted: October 29, 2012

Record last verified: 2015-10