A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).
Status and phase
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Study type
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Identifiers
Details and patient eligibility
About
The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.
At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.
HS-CRP equal or greater than 10 mg/L.
Must have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks.
Exclusion criteria
Evidence of untreated or inadequately treated latent or active TB.
Evidence or history of moderate or severe heart failure (NYHA Class III/IV)
Infection requiring hospitalization or parenteral antimicrobial therapy judged clinically significant by the investigator within 6 months prior to first dose of study drug.
Trial design
Primary purpose
Allocation
Interventional model
Masking
650 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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