| A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).
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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
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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.
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| Not Provided
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| Interventional
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| Phase 3
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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| Rheumatoid Arthritis
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- Biological: PF-06410293
PF-06410293 will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
Other Name: Adalimumab-Pfizer
- Biological: Adalimumab
Adalimumab will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
Other Name: Adalimumab-European Union, Humira®
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Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, Alvarez D, Bock AE, Sewell KL. A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis. Arthritis Res Ther. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y.
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| Completed
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| 597
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| 560
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| December 6, 2017
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| August 31, 2016 (Final data collection date for primary outcome measure)
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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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| Sexes Eligible for Study: |
All |
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| 18 Years and older (Adult, Older Adult)
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| No
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Contact information is only displayed when the study is recruiting subjects
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| Australia, Brazil, Bulgaria, Colombia, Czechia, Estonia, Georgia, Germany, Hungary, Japan, Korea, Republic of, Lithuania, Mexico, New Zealand, Peru, Poland, Russian Federation, Serbia, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States
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| Canada, Czech Republic
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| NCT02480153
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B5381002
B5381002, REFLECTIONS B538-02
2014-000352-29 ( EudraCT Number )
ADALIMUMAB ( Other Identifier: Alias Study Number )
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| Yes
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| Not Provided
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| Pfizer
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| Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| January 2019
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