NNC 151-0000 in rheumatoid arthritis patients

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis

• IRAS ID

  32670

• Contact name

  S Siebert

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2009-011791-30

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  NNC 151-0000 is an investigational drug that is being tested in rheumatoid arthritis (RA) patients. RA is a chronic inflammatory disease that causes changes in the lining of joints (particularly hands, wrists, feet and knees) causing them to become inflamed, stiff and painful. RA is thought to be an autoimmune disease. NNC 151-0000 is a type of antibody which may interact with the body's immune system. It is given as an injection under the skin. This study aims to find out how safe and well-tolerated NNC 151-0000 is in RA patients, and also assess how it behaves in the body and interacts with RA. The study consists of two parts. If subjects meet the eligibility criteria decided by the study doctor and they agree to participate, the study doctor will tell them which part of the trial they will be in. In the first part, groups of RA patients will receive once weekly injections of NNC 151-0000 at different dose levels. In the other part, RA patients will receive once weekly injections at a single dose level based on the results of the first part. Subjects will only be asked to participate in one part of the study. The study is placebo controlled, meaning that subjects may receive NNC 151-0000 or a placebo (a dummy substance with identical appearance but without effective drug). Neither the subject nor the study doctor will know which they are receiving. Subjects have a 75 % change of receiving the active drug in the first part of trial, and an 80 % chance in the other part. The study lasts for up to 13 weeks, during which time subjects will receive 4 injections and visit the centre 10-12 times. Blood, urine and, where possible, joint fluid samples will be taken. A pharmaceutical company is funding this study.

• REC name

  Wales REC 3

• REC reference

  09/MRE09/55

• Date of REC Opinion

  14 Apr 2010

• REC opinion

  Further Information Favourable Opinion