This is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Following the treatment phase, there will be an 8-week safety follow-up period for those participants who do not continue into the long term-extension study.
Scipher NETWORK PrismRA
Imagine knowing if a treatment will work before you take it. Roughly 1 in 3 people living with rheumatoid arthritis (RA) who are prescribed a biologic (anti-TNF) therapy such as Humira®, Enbrel®, Remicade®, Cimzia®, Inflectra®, Simponi®, or Simponi Aria® will adequately respond to treatment. Currently, there is no tool to predict which person will respond to these drugs. Scipher Medicine aspires to change this with PrismRATM, a new test that could improve how RA is treated.
PrismRATM is an experimental blood test that may predict non-response to biologic therapies in people living with RA. This could help patients get faster access to the right therapies, saving ‘non-responders’ time and potential side-effects caused while on ineffective drugs.