A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:1/25/2019
Start Date:June 25, 2015
End Date:December 6, 2017

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A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB 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, safety, and immunogenicity of PF-06410293 and adalimumab
in combination with methotrexate in subjects with moderately to severly active rheumatoid
arthritis who have had an inadequate response to methotrexate.

In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a
subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study
treatment (PF-06410293) at home.


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 8 mg/L.

- Must have received methotrexate for at least 12 weeks and been on a stable dose for at
least 4 weeks prior to the first study dose.

Exclusion Criteria:

- Evidence of untreated or inadequately treated latent or active TB.

- Evidence of uncontrolled, clinically significant diseases, including moderate or
severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.

- History of infection requiring hospitalization or parenteral antimicrobial therapy
within 6 months prior to first dose of study drug.

- May have received no more than 2 doses of one biologic therapy (other than adalimumab
or lymphocyte depleting therapy).

- Any second DMARD must be washed out prior to the first study dose.
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Amarillo, TX
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Aventura, FL
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Battle Creek, Michigan 49015
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Beckley, West Virginia 25801
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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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Chesapeake, Virginia 23320
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Cincinnati, OH
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Clearwater, Florida 33765
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Daytona Beach, Florida 32117
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Duncansville, Pennsylvania 16635
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Fullerton, CA
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Gainesville, Florida 32607
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2100
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Gilbert, Arizona 85234
363
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Gilbert, AZ
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336
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Glendale, AZ
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Greenville, North Carolina 27834
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1360
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Houston, TX
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Jackson, Tennessee 38305
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Jackson, TN
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3725 East League City Parkway
League City, Texas 77573
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Lincoln, Nebraska 68512
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Memphis, Tennessee 38119
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Meridian, Idaho 83642
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Mesquite, Texas 75150
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New York, New York 10016
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Omaha, Nebraska 68114
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Orchard Park, New York 14127
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345
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Rapid City, South Dakota 57701
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San Leandro, California 94578
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Sarasota, Florida 34239
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Shenandoah, Texas 77380
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Southport,
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Wenatchee, Washington 98801
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Wyomissing, Pennsylvania 19610
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