A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/1/2018 |
Start Date: | August 26, 2014 |
End Date: | June 1, 2017 |
A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate
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.
with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate
response to methotrexate.
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.
We found this trial at
44
sites
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