S101-RGL-003: MabThera Biosimilar SAIT101 in RA

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

• IRAS ID

  95346

• Contact name

  Christopher Edwards

• Sponsor organisation

  Samsung Electronics Co. Ltd

• Eudract number

  2011-004171-36

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study is a global study in patients with severe rheumatoid arthritis (RA). The purpose of the study is to compare the pharmacokinetics (PK) and effectiveness of the study drug, SAIT101, to MabThera© which is currently approved to treat patients with RA. In part A (phase I) of the study, 116 eligible patients will be placed at random to receive 2 infusions of either SAIT101 or MabThera© on day 1 and day 15. Blood samples will be taken to evaluate pharmacokinetics (how the body processes the drugs). If the 2 groups are comparable and there are no safety concerns, then part B will begin at the end of week 24. In part B (phase III), a further 500 patients will be added to the study to receive 2 infusions of either SAIT101 or MabThera©. Any patients who have an inadequate response at week 24 will be eligible to receive another 2 infusions of SAIT101 or MabThera©. Patients will be in the study for 52 weeks (or 76 weeks if they receive the additional infusions). Patients will not be able to receive anti-TNFs or DMARDs during the study, except methotrexate.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0023

• Date of REC Opinion

  24 Feb 2012

• REC opinion

  Further Information Favourable Opinion