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
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.
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.
Fullerton, California 92835, United States
Battle Creek, Michigan 49015, United States
Sofia, 1612, Bulgaria
Guatemala City, 01015, Guatemala
Anjo-shi, Aichi-ken 446-8602, Japan
Iiduka, Fukuoka 820-8505, Japan
Aki-gun, Hiroshima 735-8585, Japan
Katoh, Hyōgo 673-1462, Japan
Kawagoe-shi, Saitama 350-8550, Japan
Tokorozawa-shi, Saitama 359-1111, Japan
Sunto-gun, Shizuoka 411-8611, Japan
Chuo-ku, Tokyo 104-8560, Japan
Meguro-ku, Tokyo 153-8515, Japan
Shinagawa-ku, Tokyo 142-8666, Japan
San Luis de Potosí, SAN LUIS de Potosi 78213, Mexico
Zona Universitaria, SAN LUIS de Potosi CP 78240, Mexico
San Juan de Miraflores, Lima region Lima 29, Peru
Santiago de Surco, Lima region Lima 33, Peru
Krakow, 31-121, Poland
Kursk, 305007, Russia
Saint Petersburg, 190068, Russia
Ivano-Frankivsk, 76008, Ukraine
M. Kryvyi Rih, 50056, Ukraine
M. Sumy, 40022, Ukraine
M. Vinnytsia, 21018, Ukraine
Zaporizhzhya, 69600, Ukraine