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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|ClinicalTrials.gov Identifier: NCT02480153|
Recruitment Status : Completed
First Posted : June 24, 2015
Results First Posted : September 26, 2017
Last Update Posted : March 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Biological: PF-06410293 Biological: Adalimumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||597 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||June 25, 2015|
|Primary Completion Date :||August 31, 2016|
|Study Completion Date :||December 6, 2017|
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
|Active Comparator: 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®
- Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 in the Intent-to-Treat (ITT) Population [ Time Frame: Week 0, week 2, week 4, week 6, week 8 and week 12 ]ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: participant's assessment of arthritis pain; participant's global assessment of arthritis; physician's global assessment of arthritis; high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480153
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|