Status:
COMPLETED
A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).
Lead Sponsor:
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotr...
Eligibility Criteria
Inclusion
- 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 10 mg/L.
- Must have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks.
Exclusion
- Evidence of untreated or inadequately treated latent or active TB.
- Evidence or history of moderate or severe heart failure (NYHA Class III/IV)
- Infection requiring hospitalization or parenteral antimicrobial therapy judged clinically significant by the investigator within 6 months prior to first dose of study drug.
Key Trial Info
Start Date :
August 26 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT02222493
Start Date
August 26 2014
End Date
June 1 2017
Last Update
May 30 2018
Active Locations (184)
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1
Achieve Clinical Research, LLC
Birmingham, Alabama, United States, 35216
2
Clinical and Translational Research Center of Alabama, PC
Tuscaloosa, Alabama, United States, 35406
3
Sun Valley Arthritis Center, Ltd.
Peoria, Arizona, United States, 85381
4
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix, Arizona, United States, 85037