Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315) (DOSE)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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 infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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 criteria
- 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
39 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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