CMO1031, MabThera® and Rituxan® in patients with rheumatoid arthritis.

• Research type

  Research Study

• Full title

  A phase I, randomized, double-blind, multicenter, active-control, parallel-group study to evaluate the pharmacokinetics and pharmacodynamics of CMO1031, MabThera® and Rituxan® in patients with rheumatoid arthritis

• IRAS ID

  85580

• Contact name

  John Isaacs

• Sponsor organisation

  Hospira UK Ltd,

• Eudract number

  2011-002249-36

• ISRCTN Number

  n/a

• Research summary

  This is a phase I, randomised, double-blind study funded by Hospira UK Ltd. The purpose of this study is to investigate if CMO1031 (the experimental drug under investigation) works as effectively and as safely as MabThera© and Rituxan© (2 approved drugs for the treatment of severe rheumatoid arthritis). The study is also trying to find out if CMO1031, MabThera© and Rituxan© have the same pharmacokinetic (PK) and pharmacodynamic (PD) profile. Pharmacokinetics examines the behaviour of a drug in the body over a period of time, while pharmacodynamics examines the effect the drug has on the body. The assessment of safety will include the investigation of the ability of these drugs to stimulate the formation of antibodies in the body which might cause a specific immune reaction. This is called immunogenicity. Approximately 168 female patients with active severe rheumatoid arthritis will be recruited in this study at 94 centres in 19 countries. Approximately 20 participants will be recruited in the UK. The duration of participation is expected to be approximately 12 months. This includes a screening period, a treatment period (Week 1 to Week 24) and a retreatment period (Week 24-48). During the Treatment Period participants will have an equal chance (1 in 3) of receiving CMO1031 or MabThera© or Rituxan©. Two intravenous (IV) infusions of study drug will be administered: Infusion 1 on Day 1 and Infusion 2 on Day 15. If the study doctor thinks it would be beneficial the participant may receive a further course of treatment during the Retreatment Period. Participants will have an equal chance (1 in 2) of receiving CMO1031 or MabThera©. This study involves procedures including:- Physical examination, vital signs, ECG, blood tests, urine tests, X-rays of hands and feet, assessment of joints for swelling and tenderness, Questionnaires.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  11/NE/0293

• Date of REC Opinion

  6 Dec 2011

• REC opinion

  Further Information Favourable Opinion