ABP 501 Extension Study
Research type
Research Study
Full title
An Open-Label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis
IRAS ID
146925
Contact name
Adewale Adebajo
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2013-004654-13
Research summary
This is a multicentre, multinational open label extension study to evaluate the long term safety and efficacy of ABP 501 in participants with moderate to severe rheumatoid arthritis.
Rheumatoid arthritis is an autoimmune disease that results in a chronic, systemic inflammatory disorder that may affect many tissues and organs, but principally attaches flexible (synovial) joints. It can be a disabling and painful condition, which can lead to substantial loss of functioning and mobility if not adequately treated. Rheumatoid arthritis affects 5800,000 people in England, which suggests that over 690,00 adults in the UK live with the condition.
The purpose of this study it to look at the long term safety and how well ABP 501 works in men and women who completed study 20120262 and who have moderate to severe rheumatoid arthritis. Adalimumab is the standard of care medicine for patients with moderate to severe rheumatoid arthritis. ABP 501 has been developed as a biosimilar to adalimumab, meaning the medications are nearly identical. Study 20120262 demonstrated the clinical biosimilarity, specifically, that there is no clinical meaningful difference between ABP 501 and adalimumab in terms of safety, effectiveness, and immunogenicity between the two medications.
All of the approximate 425 enrolled participants will receive ABP 501 40mg every other week for 18 months.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/0020
Date of REC Opinion
12 Feb 2014
REC opinion
Favourable Opinion