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

Condition(s) targeted: Psoriasis

Intervention: Infliximab (Biological)

Phase: N/A

Status: Recruiting

Sponsored by: Schering-Plough

Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

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.

Official title: Real-World Assessment of Long-Term Infliximab Therapy for Psoriasis

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: The proportion of subjects with a PASI-75 response (change in PASI of >=75% from Baseline) at Week 50.

Secondary outcome:

Baseline characteristics by PASI 75 response

The proportion of subjects with PASI 75 response.

The proportion of subjects with PASI-90 response.

The proportion of subjects with PASI 100 response.

The subjects' raw PASI scores at Visit 2/Week 14.

The subjects' raw PASI scores at Visit 3/Week 30

The subjects' raw PASI scores at Visit 4/Week 50 (Follow Up).

DLQI to assess quality of life

DLQI to assess quality of life

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

Investigational Site 109, Kogarah 2217, Australia; Recruiting

Investigational Site 111, Parkville 3050, Australia; Recruiting

Investigational Site 74, Brugge, Belgium; Recruiting

Investigational Site 73, Brussels, Belgium; Recruiting

Investigational Site 76, Edegem, Belgium; Completed

Investigational Site 75, Gent, Belgium; Recruiting

Investigational Site 77, Liege, Belgium; Recruiting

Investigational Site 7, Alma G8B 1N1, Canada; Recruiting

Investigational Site 18, Halifax B3H 1Z4, Canada; Recruiting

Investigational Site 13, London N5X 2P1, Canada; Recruiting

Investigational Site 19, Markham L3P 1A8, Canada; Recruiting

Investigational Site 17, Mississauga L4Y 1A6, Canada; Recruiting

Investigational Site 10, Montreal H3Z 2S6, Canada; Recruiting

Investigational Site 23, Oakville L6J 7W5, Canada; Recruiting

Investigational Site 9, Quebec G1J 1X7, Canada; Recruiting

Investigational Site 12, St. John's A1B 4S8, Canada; Recruiting

Investigational Site 16, St. John's A1A 5E8, Canada; Recruiting

Investigational Site 26, St. John's A1B 4S8, Canada; Recruiting

Investigational Site 6, Surrey V3R 6A7, Canada; Recruiting

Investigational Site 24, Toronto M5S1B2, Canada; Recruiting

Investigational Site 95, Victoria, Canada; Recruiting

Investigational Site 8, Welland L3C 3W4, Canada; Recruiting

Investigational Site 25, Windsor N8W 5L7, Canada; Recruiting

Investigational Site 57, Aarhus 8000 C, Denmark; Recruiting

Investigational Site 55, Copenhagen 2400 NV, Denmark; Recruiting

Investigational Site 56, Hellerup 2900, Denmark; Recruiting

Investigational Site 104, Besancon Cedex 25030, France; Recruiting

Investigational Site 105, Brest Cedex 29609, France; Recruiting

Investigational Site 106, Chambray-les-Tours 37170, France; Recruiting

Investigational Site 102, Limoges 87042, France; Recruiting

Investigational Site 107, Lyon 69437, France; Recruiting

Investigational Site 98, Nice Cedex 3 06202, France; Recruiting

Investigational Site 100, Paris Cedex 10 75475, France; Recruiting

Investigational Site 101, Poitiers Cedex 86021, France; Recruiting

Investigational Site 99, Toulouse 31059, France; Recruiting

Investigational Site 53, Augsburg 86179, Germany; Recruiting

Investigational Site 130, Bad Bentheim 48455, Germany; Recruiting

Investigational Site 48, Berlin 10827, Germany; Recruiting

Investigational Site 50, Blaubeuren 89143, Germany; Recruiting

Investigational Site 54, Dresden 01307, Germany; Recruiting

Investigational Site 39, Giessen/Lahn 35390, Germany; Recruiting

Investigational Site 46, Hamburg 20354, Germany; Recruiting

Investigational Site 43, Kiel 24105, Germany; Recruiting

Investigational Site 40, Kiel 24148, Germany; Recruiting

Investigational Site 47, Leipzig 04103, Germany; Recruiting

Investigational Site 51, Mahlow 15831, Germany; Recruiting

Investigational Site 128, Quedlinburg 06484, Germany; Recruiting

Investigational Site 49, Stuttgart 70374, Germany; Recruiting

Investigational Site 93, Budapest 1085, Hungary; Recruiting

Investigational Site 94, Debrecen 4012, Hungary; Recruiting

Investigational Site 92, Szeged 6720, Hungary; Recruiting

Investigational Site 70, Benevento 82100, Italy; Recruiting

Investigational Site 69, Catania 95100, Italy; Recruiting

Investigational Site 68, Palermo 90100, Italy; Recruiting

Investigational Site 116, Monterrey 64710, Mexico; Recruiting

Investigational Site 1, Alkmaar 1815 KX, Netherlands; Withdrawn

Investigational Site 3, Breda 4818 CK, Netherlands; Recruiting

Investigational Site 82, Ekaterinburg 620076, Russian Federation; Recruiting

Investigational Site 79, Korolev 141070, Russian Federation; Completed

Investigational Site 84, Moscow 107076, Russian Federation; Recruiting

Investigational Site 88, Saint-Petersburg 192102, Russian Federation; Recruiting

Investigational Site 80, Saratov 410028, Russian Federation; Recruiting

Investigational Site 132, Newport NP9 2UB, United Kingdom; Recruiting

Starting date: October 2008
Last updated: August 17, 2010