Baricitinib in Patients with Rheumatoid Arthritis: BUILD (JADX)

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis

• IRAS ID

  116853

• Contact name

  Bruce Kirkham

• Sponsor organisation

  Lilly UK

• Eudract number

  2012-002339-27

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Rheumatoid Arthritis (RA) is an illness where patient develops an immune response to normal body tissues (an autoimmune disease). Although RA is mainly affecting the joints - causing pain, swelling and eventually resulting in varying degrees of joint deformation and associated muscle wasting - other systems in the body can also be involved and so causing general ill health. Management of RA has improved substantially in recent years. In addition to improvement in symptoms and joint damage, clinical remission is now considered an achievable goal. However, despite a variety of approved treatments for RA complete or sustained remission is unusual. Baricitinib is being developed for treatment of patients with moderately to severely active RA who are intolerant to or who have had an unsatisfactory response to conventional disease-modifying antirheumatic drug (cDMARDs) - including Methotrexate. To be eligible for enrolment in this study patients must be at least 18 years of age, have not received previous treatment with a biologic DMARDs (disease modifying antirheumatic drugs).The study will consist of a screening phase lasting up to 42 days and a 24 week treatment phase. Patients will then either discontinue treatment and a follow up visit will be performed 28 days after their last dose of study drug or they will continue on to an extension study (JADY). Study assessments will include: Physical examinations, X-Rays, blood and urine test and questionnaires.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  13/LO/0128

• Date of REC Opinion

  21 Mar 2013

• REC opinion

  Further Information Favourable Opinion