A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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 methotrexate.

Key facts

Study ID

NCT02222493

Run by

Pfizer

People needed

650

Starts

2014-08-26

Expected to finish

2017-06-01

Last updated by the study team

2018-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical and Translational Research Center of Alabama, PC — Tuscaloosa, Alabama, United States
• Sun Valley Arthritis Center, Ltd. — Peoria, Arizona, United States
• Arizona Arthritis & Rheumatology Associates, P.C. — Phoenix, Arizona, United States
• St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare — Fullerton, California, United States
• Arthritis & Osteoporosis Medical Center — La Palma, California, United States
• Inland Rheumatology Clinical Trials, Inc. — Upland, California, United States
• Desert Valley Medical Group — Victorville, California, United States
• Javed Rheumatology Associates, Inc — Newark, Delaware, United States
• Arthritis and Rheumatic Disease Specialties — Aventura, Florida, United States
• International Medical Research — Daytona Beach, Florida, United States
• Study site — Daytona Beach, Florida, United States
• San Marcus Research Clinic, Inc. — Miami, Florida, United States
• Advance Medical Research Services Corporation — Miami, Florida, United States
• Sarasota Arthritis Research Center — Sarasota, Florida, United States
• Alastair C. Kennedy, MD — Vero Beach, Florida, United States
• Indian River Primary Care — Vero Beach, Florida, United States
• Harbin Clinic — Rome, Georgia, United States
• Advanced Clinical Research — Meridian, Idaho, United States
• Methodist Medical Center of IL — Peoria, Illinois, United States
• Physician's Clinic of Iowa, P.C. — Cedar Rapids, Iowa, United States
• Gilbert-Graves Clinic — Bowling Green, Kentucky, United States
• Graves-Gilbert Clinic Bowling Green — Bowling Green, Kentucky, United States
• Ochsner Clinic Baton Rouge — Baton Rouge, Louisiana, United States
• Arthritis and Diabetes Clinic, Inc. — Monroe, Louisiana, United States
• Achieve Clinical Research, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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