DOSE
Research type
Research Study
Full title
A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis (DOSE)
IRAS ID
38380
Contact name
Christopher E M Griffiths
Sponsor organisation
Schering-Plough Research Institute
Eudract number
2008-000454-12
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
This is a multicentre, open-label, interventional study of infliximab treatment in adults with moderate to severe plaque-type psoriasis. This study recruits subjects from Study P05319, which is an observational, multicentre, 50-week study assessing the clinical response in real-world practice of long-term maintenance therapy of plaque-type psoriasis subjects with infliximab. The study is expected to randomise approximately 200 subjects originally enrolled in Study P05319, who had achieved an improvement in PASI score of between =25% and <75% from Baseline of Study P05319 between Weeks 23 and 50 (inclusive). Once a subject is randomised in this study, P05315, he or she will be discontinued from Study P05319. Each subject will participate in the study for approximately 36 weeks from the time they sign the Informed Consent Form (ICF) through to the final contact. The subjects will undergo a Screening Period of up to 8 weeks from the last infliximab infusion of observational study P05319. On Visit 2/Baseline/Week 0, eligible subjects will be randomised in a 1:1 ratio to receive either infliximab every 8 weeks plus methotrexate every week; or infliximab every 6 weeks (shortened interval treatment). The treatment will start at this visit and the maximum duration of treatment will be approximately 24 weeks. Subjects randomised to infliximab plus methotrexate therapy will receive intravenous infliximab every 8 weeks at Weeks 0, 8, 16, and 24 and will take methotrexate 7.5 mg orally once a week. Subjects in the infliximab shortened interval arm will receive intravenous infliximab once every 6 weeks at Weeks 0, 6, 12, 18, and 24. All subjects will attend a follow up visit 4 weeks after their last infliximab infusion.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
10/H1003/5
Date of REC Opinion
9 Apr 2010
REC opinion
Further Information Favourable Opinion