A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).
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|ClinicalTrials.gov Identifier: NCT02222493|
Recruitment Status : Completed
First Posted : August 21, 2014
Results First Posted : September 11, 2017
Last Update Posted : September 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Biological: PF-06438179 Biological: Infliximab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||650 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-06438179 And Infliximab 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 :||August 26, 2014|
|Actual Primary Completion Date :||June 29, 2016|
|Actual Study Completion Date :||June 1, 2017|
PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Other Name: Infliximab-Pfizer
|Active Comparator: Infliximab||
Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Other Name: Infliximab-EU, Remicade
- Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14 in the Intent-to-Treat (ITT) Population [ Time Frame: Week 0, Week 2, Week 4, Week 6, Week 12, and Week 14 ]ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
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): NCT02222493
Show 184 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|