A Phase 1b study evaluating PK, PD and safety of TL011 in RA

• Research type

  Research Study

• Full title

  A Phase Ib study evaluating safety, pharmacokinetic and pharmacodynamic profiles of a single course of TL011 infusions in subjects with severe, active rheumatoid arthritis.

• IRAS ID

  47746

• Contact name

  Tom Sheeran

• Sponsor organisation

  Teva Pharmaceuticals Ltd

• Eudract number

  2009-015702-18

• Clinicaltrials.gov Identifier

  NCT01123070

• Research summary

  The purpose of this study is to determine the safety and pharmacology of a new drug, TL011, in patients with severe rheumatoid arthritis. Rheumatoid arthritis is a disease of the joints, and B lymphocytes are involved in the cause of some of the symptoms. A total of 56 people with severe rheumatoid arthritis in Italy, Hungary, Czech Republic, Spain and the UK will take part in this study. Subjects will be divided into two groups. One group will be receiving TL011 (1000mg per infusion) and the other group will receive MabThera© (1000mg per infusion).The study will be randomised meaning that subjects will be selected to one of the two groups are selected by chance (like flipping a coin). The study will consist of a screening period of up to 14 days, an 8-week -core study- period and a 16-week extended follow-up period.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/H1008/64

• Date of REC Opinion

  24 Sep 2010

• REC opinion

  Further Information Favourable Opinion