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

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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.
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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Bowling Green, Kentucky 42101
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Cedar Rapids, Iowa 52401
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Charleston, South Carolina 29406
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Duncansville, Pennsylvania 16635
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Jackson, Tennessee 38305
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La Palma, California 90623
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Memphis, Tennessee 38119
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Meridian, Idaho 83642
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10260 Southwest 56th Street
Miami, Florida 33165
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Monroe, Louisiana 71203
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Peoria, Illinois 61636
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640 Flormann Street
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Southport, Queensland 4215
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