Status:
TERMINATED
Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab i...
Eligibility Criteria
Inclusion
- Subjects must have a diagnosis of moderate to severe plaque-type psoriasis and have had participated in Study P05319.
- Subjects must have demonstrated an adequate but suboptimal response to infliximab in Study P05319
- Subjects must be at least 18 years old
- Subjects must be candidates for phototherapy or systemic treatment for psoriasis.
- Subjects must not be pregnant and must meet contraceptive requirements
- Subjects must meet tuberculosis screening criteria
- Subjects must meet laboratory and medical history screening requirements
Exclusion
- Subjects for whom infliximab or methotrexate is contraindicated or not recommended.
- Subjects already using certain investigational, biological, or immunosuppressive drugs
- Subjects with certain comorbid conditions
- Subjects who currently have or have a history of certain infections
- Subjects who have recently received live virus or bacterial vaccinations
- Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00833053
Start Date
October 1 2009
End Date
April 1 2011
Last Update
April 12 2017
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