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.
We found this trial at
44
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Bowling Green, Kentucky 42101
278
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Bowling Green, KY
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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497
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Birmingham, AL
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Austin, Texas 78731
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Aventura, FL
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Baton Rouge, Louisiana 70809
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Baton Rouge, LA
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Battle Creek, MI
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Bowling Green, Kentucky 42101
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Cedar Rapids, Iowa 52401
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Cedar Rapids, IA
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Charleston, South Carolina 29406
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Charleston, SC
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Dallas, TX
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Daytona Beach, Florida 32117
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Daytona Beach, FL
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Daytona Beach, FL
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Duncansville, Pennsylvania 16635
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Fullerton, CA
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Houston, TX
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Jackson, Tennessee 38305
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Jackson, TN
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La Palma, California 90623
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La Palma, CA
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Memphis, Tennessee 38119
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Memphis, TN
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Meridian, Idaho 83642
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Meridian, ID
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10260 Southwest 56th Street
Miami, Florida 33165
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Miami, FL
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Miami, Florida 33015
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Miami, FL
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Minot, North Dakota 58701
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Monroe, Louisiana 71203
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Nassau Bay, Texas 77058
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Newark, Delaware 19713
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Newark, DE
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Norfolk, VA
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Peoria, Arizona 85381
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Peoria, Illinois 61636
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Peoria, IL
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Phoenix, AZ
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640 Flormann Street
Rapid City, South Dakota 57701
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Rapid City, South Dakota
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Rome, Georgia 30165
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Rome, GA
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Sarasota, Florida 34239
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Sarasota, FL
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Seattle, Washington 98133
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Seattle, WA
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14 Hill Street
Southport, Queensland 4215
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Southport,
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Tuscaloosa, AL
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Upland, CA
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Vero Beach, Florida 32960
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Vero Beach, FL
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Vero Beach, Florida 32960
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Victorville, California 92395
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Voorhees, NJ
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Wheaton, MD
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Wyomissing, Pennsylvania 19610
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