ABP 501 Compared to Adalimumab for Rheumatoid Arthritis
Research type
Research Study
Full title
A RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF ABP 501 EFFICACY AND SAFETY COMPARED TO ADALIMUMAB IN SUBJECTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS
IRAS ID
130971
Contact name
Adewale Adebajo
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2013-000525-31
ISRCTN Number
n/a
Research summary
The present study is a multicentre, multinational, randomised, double-blind, study to compare the efficacy and safety of ABP 501 with Adalimumab in patients 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 attacks 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 580,000 people in England, which suggests that over 690,000 adults in the UK live with the condition.
The purpose of the study is to compare the safety and efficacy of ABP 501 with adalimumab (Humira®) in men and women with moderate to severe rheumatoid arthritis. ABP 501 has been developed as a biosimilar to adalimumab, meaning the medications are nearly identical. The current study is designed to demonstrate the clinical biosimilarity, specifically, that there is no clinically meaningful difference between ABP 501 and adalimumab in terms of safety, effectiveness, and immunogenicity between the two medications.
Subjects will be randomised in a 1:1 ratio to receive either ABP 501 or adalimumab and will be carried out at approximately 150 hospitals with approximately 500 patients that will be invited to participate.
The participants will receive study medication for 22 weeks, plus a screening period of up to 4 weeks, efficacy analysis at week 24 followed by a safety follow up period through week 26, for a total of up to 30 weeks.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
13/YH/0235
Date of REC Opinion
9 Aug 2013
REC opinion
Favourable Opinion