UCB4940 as add-on to Certolizumab Pegol for Rheumatoid Arthritis
Research type
Research Study
Full title
A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis
IRAS ID
187162
Contact name
Peter Taylor
Contact email
Sponsor organisation
UCB Celltech, UK Registered Branch of UCB Pharma SA
Eudract number
2014-003307-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 18 days
Research summary
Rheumatoid Arthritis (RA) is a chronic, systemic, autoimmune disease that causes inflammation of peripheral joints. Untreated, RA can lead to destruction, deformation, and dysfunction of affected joints, which in turn may contribute to significant morbidity and increased mortality. RA is usually treated with disease-modifying anti-rheumatic drugs (DMARDs), with methotrexate being most commonly used. For patients who do not respond well to conventional DMARDs alone, medications that blocks tumour necrosis factor alpha (TNFα blockers) can be used in combination. TNFα is a protein in the body that is involved in inflammation, and so blocking the action of this can help with conditions such as RA that involve inflammation. However, RA is a complex disease, and patient responses to standard treatments are variable.
The purpose of this study is to assess the safety and tolerability as well as efficacy of a new experimental medication UCB4940, in combination with another medication certolizumab pegol, in the treatment of RA .
UCB4940 is an antibody (a protein involved in fighting infection) blocking a naturally occurring substance called interleukin 17 (IL-17). IL-17 is involved in RA, as it promotes inflammation. Studies in animals showed that blocking of IL-17 might help the treatment of rheumatoid arthritis.
Certolizumab pegol (trade name Cimzia®) is a medicine manufactured by UCB and approved for the treatment of moderate-to-severe rheumatoid arthritis in 53 countries including Russia and countries inside the European Union. Certolizumab pegol is also an antibody. It works by blocking a naturally occurring substance in the body called tumour necrosis factor (TNF). Tumour necrosis factor is involved in rheumatoid arthritis, as it promotes the inflammatory response.
This study aims to enrol at least 102 male and female participants over the age of 18, across approximately 18 centres in Europe and Russia. The study will last for up to 48 weeks for each participant.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0554
Date of REC Opinion
16 Oct 2015
REC opinion
Further Information Favourable Opinion