Study of 2 dose levels of AK106 001616 in patients with RA

• Research type

  Research Study

• Full title

  A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis

• IRAS ID

  63152

• Contact name

  Andrew Ostor

• Sponsor organisation

  Asahi Kasei Pharma Corporation

• Eudract number

  2010-021558-21

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  There are many medications that have been approved for the treatment of Rheumatoid Arthritis, and they have very different mechanisms of action. Medications such as modern disease-modifying antirheumatic drugs (DMARDS) and biological products are often supplemented with pain relieving and anti-inflammatory drugs.Unfortunately, the use of the anti-rheumatic medications on the market is commonly associated with typical side effects such as gastric bleeding, kidney damage, and cardiovascular damage. So there is a push to develop new, effective medications that exhibit similar or better anti-inflammatory effects, but with a favourable side-effects profile. The investigational product AK106-001616 is a medication with an entirely novel mechanism of action for treating rheumatoid arthritis. It is in an early stage of development, so it has not yet been approved for sale on the pharmaceutical market. Results from animal experiments and its initial use in healthy volunteers and Rheumatoid Arthritis patients are available. The purpose of this study is to investigate the safety and efficacy of AK106 001616 (Study Drug) when administered as multiple oral (by mouth) doses to patients with Rheumatoid Arthritis.This study will be performed to compare the safety, efficacy and other effects of AK106 001616 in Rheumatoid Arthritis patients with that of an already licensed and marketed comparator drug. The dose levels for this study are based on the available data and the results from previous clinical studies. Participants aged between 18 and 65 years and will be recruited and who have been stable on oral methotrexate therapy for at least 12 weeks.It is estimated 240 patients will participate in this study. Participation in the study will last for up to 8 weeks. Approximately 30 sites will take part in this research study.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  10/H0304/79

• Date of REC Opinion

  28 Mar 2011

• REC opinion

  Further Information Favourable Opinion