I4V-MC-JAJA Baricitinib in RA (RA-BRIDGE)
Research type
Research Study
Full title
Protocol I4V-MC-JAJA (RA-BRIDGE) Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis
IRAS ID
250571
Contact name
Dearbhaile McEvoy
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2018-003351-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 7 months, 25 days
Research summary
Rheumatoid Arthritis (RA) is a long term inflammatory disease that occurs when the immune system mistakenly attacks the body’s own tissues. RA affects the lining of the joints, causing pain, swelling and stiffness that can eventually result in bone erosion and joint deformity. It is unknown what starts this process, however a genetic component seems likely, that may allow for certain environmental factors to trigger the disease. Signs and symptoms can vary in severity, and patients can undergo periods of increased disease activity (flares) and periods where the swelling and pain decreases. People with RA also experience signs and symptoms outside the joints, such as tiredness, increased risk of cancer, infections and venous thromboembolisms.
There is no cure for RA, however with early diagnosis and suitable treatment, long term damage can be minimised or prevented. Current treatments include administration of non-steroidal anti-inflammatory drugs (NSAIDS), disease modifying antirheumatic drugs (DMARDS), corticosteroids and surgery.
The Janus Kinase (JAK) pathway is a cell-signalling pathway that controls the production of proteins that trigger the inflammatory response. The inflammatory response is important to protect tissues in the body from injury, for example by trauma or bacteria. However, in RA patients, this pathway is over stimulated. Baricitinib inhibits the activity of some of these proteins, reducing and controlling the over stimulation of this pathway.
Baricitinib has been investigated and is currently being investigated for the treatment of inflammatory diseases. Baricitinib has received approval for the treatment of RA in countries including member states of the European Union, Japan and USA.This study aims to evaluate the safety of baricitinib compared with tumour necrosis factor (TNF) inhibitors in patients with RA and will include about 2600 participants worldwide. Study assessments will include physical examinations, questionnaire completion and blood tests.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0363
Date of REC Opinion
8 Aug 2019
REC opinion
Further Information Favourable Opinion