A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT02480153

Run by

Pfizer

People needed

597

Starts

2015-06-25

Expected to finish

2017-12-06

Last updated by the study team

2019-01-23

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 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Arthritis & Rheumatology Associates, PC — Glendale, Arizona, United States
• Arizona Arthritis & Rheumatology Associates, PC — Phoenix, Arizona, United States
• St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare — Fullerton, California, United States
• East Bay Rheumatology Medical Group, Inc. — San Leandro, California, United States
• Westlake Medical Research — Thousand Oaks, 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
• Robert W. Levin, MD, PA — Clearwater, Florida, United States
• International Medical Research — Daytona Beach, Florida, United States
• SIMED Arthritis Center — Gainesville, Florida, United States
• Southeastern Integrated Medical, PL, d/b/a Florida Medical Research — Gainesville, Florida, United States
• Rheumatology Associates of Central Florida, P.A. — Orlando, 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
• St Luke's Intermountain Research Center — Boise, Idaho, United States
• St Luke' s Clinic — Meridian, Idaho, United States
• Physician's Clinic of Iowa, P.C. — Cedar Rapids, Iowa, United States
• Graves-Gilbert Clinic Bowling Green — Bowling Green, Kentucky, United States
• The Center for Rheumatology and Bone Research — Wheaton, Maryland, United States
• Bronson Internal Medicine and Rheumatology — Battle Creek, Michigan, United States
• North Mississippi Medical Clinics, Inc. - Clinical Research — Tupelo, Mississippi, United States
• ArthroCare, Arthritis Care & Research P.C. — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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