Protocol NN8226-3612: Anti-IL-20-NNC0109-0012 in Rheumatoid Arthritis

• Research type

  Research Study

• Full title

  A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics

• IRAS ID

  109901

• Contact name

  Adewale Adebajo

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2012-000609-58

• Research summary

  Rheumatoid arthritis (RA) is an autoimmune disease which causes pain, stiffness and swelling in and around the joints. ??Autoimmune disease?? basically means that the body tissues are attacked by its own immune system. The currently available treatment options help to decrease the severity of the disease and may also improve quality of life for patients. Currently, no permanent cure exists for RA and due to the large number of people who suffer from this disease, the development of new treatments for RA is vital. The purpose of this clinical study is to see whether a new trial drug called Anti-IL-20- NNC0109-0012 (Anti-IL-20 for short) is safe and effective for the treatment of RA. The study will also learn about how Anti-IL-20 interacts with the body. This study is a randomised, double blind, placebo-controlled trial. This means that patients will be put into the different treatment groups randomly (by chance like flipping a coin), that neither the patient nor the study doctor will know what treatment the patient is receiving and that one of the treatment groups will be an inactive dummy drug (the placebo). In total, the study will include about 268 patients and will be conducted in several countries around the world. All patients will be allocated to one of four treatment groups consisting of the following: Three active treatment groups (60 milligrams, 120 milligrams, 240 milligrams) and one placebo group. Treatment will be administered by injection (under the skin) once a week at the study doctor??s hospital. The study lasts for 24 weeks followed by a 28 week open label extension for a total trial duration up to 52 weeks for each patient. Open label means that in the extension part of the study, all participants will be given Anti-IL-20.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0521

• Date of REC Opinion

  1 Nov 2012

• REC opinion

  Further Information Favourable Opinion