Baricitinib in Patients with Rheumatoid Arthritis: BEGIN (JADZ)

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs

• IRAS ID

  113276

• Contact name

  Bruce Kirkham

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2012-002324-32

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Rheumatoid Arthritis (RA) is a systematic inflammatory, autoimmune disease. Symptoms vary from mild to severe. Patients who suffer severe symptoms may experience progressive joint destruction and a significantly compromised quality of life. Management of RA has improved substantially in recent years. In addition to improvement in symptoms and structural 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 either intolerant to Methotrexate or who have had an inadequate response to disease modifying anti-rheumatic drugs (DMARDs). To be eligible for enrolment in this study patients must be at least 18 years of age with moderately to severely active RA who have had limited or no treatment with DMARDs. The study will consist of a screening phase lasting up to 42 days and a 52 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 continue on to an extension study (JADY). Study assessments will include: Physical examinations, X-rays, blood and urine tests and questionnaires. Some patients will also have the opportunity to take part in an addendum to the study where they will have regular MRI scans to monitor their disease.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  12/LO/1973

• Date of REC Opinion

  31 Jan 2013

• REC opinion

  Further Information Favourable Opinion