GP15-301 Study to compare GP2015 and Enbrel® in Rheumatoid Arthritis
Research type
Research Study
Full title
A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis
IRAS ID
186367
Contact name
Maya Buch
Contact email
Sponsor organisation
Hexal AG
Eudract number
2012-002009-23
Duration of Study in the UK
1 years, 11 months, 26 days
Research summary
This is a phase 3, randomised double blind clinical study comparing efficacy, safety and immunogenicity of GP2015 and Enbrel® (etanercept) in patients with moderate to severe active Rheumatoid Arthritis (RA). The study is sponsored by Hexal AG.
Enbrel® and GP2015 are biological treatments for Rheumatoid Arthritis; GP2015 is designed to be similar to Enbrel®. Both work by binding substances in the body that are responsible for maintaining inflammation.
The same side effects are expected for GP2015 and Enbrel®. Safety information on GP2015 is still limited and is derived from GP2015 development program, including animal studies, 4 Phase I clinical studies in healthy volunteers and a Phase III clinical study with plaque-type psoriasis (currently reporting). There were no safety concerns up to date related with the use of GP2015.
The purpose of this study is to compare GP2015 to Enbrel® and to generate additional data on efficacy, safety and immunogenicity (the reaction of your body against the study medication) in patients with RA.
Total of 366 patients will be enrolled in this study at approximately 140 centers in the UK and other countries. A screening visit is followed by Treatment period 1 (7 visits over a 24 week period). Participants will be randomly assigned to receive either GP2015 or Enbrel®. They will have an equal chance of receiving either, but will not know which treatment they are on. If the assigned treatment is effective in period 1, participants will continue the study with treatment period 2, during which all of them will receive GP2015 for a further 24 weeks (with 4 study visits). Participants finishing early will have an early termination visit.Study procedures include an ECG a screening. A physical exam, blood tests, vital signs (such as height, weight, blood pressure) a joint count (to assess RA) and questionnaires will be completed at most visits.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0485
Date of REC Opinion
9 Dec 2015
REC opinion
Further Information Favourable Opinion