An exploratory trial to assess naturalistic safety and efficacy outcomes in patients trasitioned to ustekinumab from previous methotrexate therapy
- Conditions
- Psoriasis10011063
- Registration Number
- NL-OMON33158
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Men and women, aged 18 years or older, with moderate to severe plaque psoriasis who have a Psoriasis Area and Severity Index (PASI) >=10 and who have failed or are intolerant to methotrexate therapy. Patient entering the study must be receiving a minimum dose of 10mg of methotrexate per week, and should have been receiving methotrexate for at least 8 weeks prior to screening.
Currently receiving ciclosporin, fumarates, PUVA, etanercept, efalizumab, infliximab, adalimumab or alefacept.
Currently receiving any other systemic treatment (Except MTX) that may improve psoriasis.
Currently receiving biological therapy within the past 12 weeks or 5 half lives, whichever is greater.
Have received natalizumab, efalizumab or agents that deplete B or T cells within 12 months of screening, or, if later receiving these agents, evidence is available at screening of present depletion of the targeted lymphocyte population.
Have received, or are expected to receive a BCG vaccination within 12 months prior screening, during the stuy, or within 12 months after the last administration of study agent.
Have had or have serious infection, or have been hospitalized or received IV antibiotics for an infection during two months prior to screening.
Have evidence of current active infection, including TB or a nodule suspicious for lung malignancy on screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this exploratory trial is to evaluate the comparative<br /><br>safety through week 12 of two treatment transition strategies in patients with<br /><br>inadequate response to methotrexate: discontinuation of methotrexate with<br /><br>immediate initiation of ustekinumab versus initiation of ustekinumab with<br /><br>overlap and gradual dose reduction of methotrexate over 4 weeks.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Objectives of the study include evaluating the safety, efficacy, and<br /><br>quality of life through Week 52.</p><br>