Efficacy and safety of PF06410293 and Adalimumab in RA
Research type
Research Study
Full title
A PHASE 3 RANDOMISED, 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.
IRAS ID
159001
Contact name
Paul Emery
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2014-000352-29
Clinicaltrials.gov Identifier
REFLECTIONS B538-02, Other ID
Research summary
Rheumatoid Arthritis (RA) is an autoimmune inflammatory disease which affects the body’s movable small joints (fingers, thumbs, wrists, feet, and ankles) and big joints (knees, hips, shoulders, elbows, and neck). Small joints and knees are commonly affected. RA is caused when antibodies that defend the body against bacteria, viruses, and other germs, attack the tissue surrounding the joints. In cases where the antibody Rheumatoid Factor (RF) is found, patients suffer the most aggressive form of RA, characterised by rheumatoid nodules, inflammation of blood vessels, white of the eye and the pericardium - the sac which surrounds the heart, and Felty’s syndrome (combination of rheumatoid arthritis, splenomegaly and neutropenia). Sufferers of RA have a reduced quality of life and life expectancy.
The current treatments of RA include:
i) Disease-modifying anti-rheumatic drugs e.g. methotrexate
ii) Biologic therapies targeting cytokines such as anti-TNF therapy
iii) B-cell depleting agents (e.g., rituximab)
Inflammation occurs after a cascade of reactions. Stopping one/more reactions within this cascade can reduce or resolve clinical development. An important reaction in the inflammatory cascade involves a small protein tumour necrosis factor-alpha (TNFa). Blocking TNFa by using an antagonist stops/reduces inflammation (Anti-TNF therapy). Anti-TNF agents include adalimumab (marketed as HUMIRA®), the study drug.Pfizer have developed a new form of adalimumab, PF-06410293 (adalimumab-Pfizer). The aim of this study is to test whether PF-06410293 is biologically similar to HUMIRA. Biosimilarity will be supported by safety and efficacy studies. Access to antibody therapies is limited in some regions, due to their cost. Pfizer hope by developing a biosimilar drug, they can provide patients with cost effective treatments and improve patient access.
The study will be done at about 212 different research sites in 28 countries. Approximately 560 people will be enrolled. Participants will be in this study for about 85 weeks.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
14/SC/1203
Date of REC Opinion
29 Oct 2014
REC opinion
Further Information Favourable Opinion