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.
We found this trial at
50
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Victorville, California 92395
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Victorville, CA
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1078
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Amarillo, TX
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Austin, Texas 78731
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Austin, TX
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981
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Aventura, FL
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Battle Creek, Michigan 49015
195
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Battle Creek, MI
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Beckley, West Virginia 25801
180
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Beckley, WV
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1713
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Boise, ID
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Bowling Green, Kentucky 42101
278
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Bowling Green, KY
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Cedar Rapids, Iowa 52401
471
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Cedar Rapids, IA
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Charleston, South Carolina 29406
525
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Charleston, SC
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Chesapeake, Virginia 23320
430
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Chesapeake, VA
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98
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Cincinnati, OH
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Clearwater, Florida 33765
829
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Clearwater, FL
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905
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Dallas, TX
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Daytona Beach, Florida 32117
751
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Duncansville, Pennsylvania 16635
244
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Duncansville, PA
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1959
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Fullerton, CA
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Gainesville, Florida 32607
713
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Gainesville, FL
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713
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Gainesville, FL
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Gilbert, Arizona 85234
1648
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Gilbert, AZ
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1665
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Glendale, AZ
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Greenville, North Carolina 27834
429
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Greenville, NC
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992
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Houston, TX
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Jackson, Tennessee 38305
436
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Jackson, TN
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3725 East League City Parkway
League City, Texas 77573
991
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League City, TX
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Lincoln, Nebraska 68512
721
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Lincoln, NE
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Memphis, Tennessee 38119
508
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Meridian, Idaho 83642
1725
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Meridian, ID
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Mesquite, Texas 75150
901
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New York, New York 10016
478
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New York, NY
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Newark, Delaware 19713
386
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Newark, DE
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Omaha, Nebraska 68114
688
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Omaha, NE
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Orchard Park, New York 14127
294
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Orchard Park, NY
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796
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Orlando, FL
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1654
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Phoenix, AZ
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Rapid City, South Dakota
1072
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Rapid City, SD
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Rapid City, South Dakota 57701
1072
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San Leandro, California 94578
2093
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San Leandro, CA
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Sarasota, Florida 34239
872
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Shenandoah, Texas 77380
973
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Shenandoah, TX
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9153
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Southport,
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Thousand Oaks, California 91360
2001
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503
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Tupelo, MS
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1939
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Upland, CA
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Vero Beach, Florida 32960
864
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Vero Beach, Florida 32960
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427
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Voorhees, NJ
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Wenatchee, Washington 98801
1912
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324
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Wheaton, MD
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Wyomissing, Pennsylvania 19610
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