BI 695500 versus Rituximab in Rheumatoid Arthritis Study 1301.1

• Research type

  Research Study

• Full title

  Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

• IRAS ID

  104198

• Contact name

  Ernest Choy

• Sponsor organisation

  Boehringer Ingelheim International GmbH

• Eudract number

  2011-002894-48

• ISRCTN Number

  to be registered

• 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 and if left untreated, RA may lead to severe functional disabilities and therefore a considerable reduction in quality of life for the patient. The drug Rituximab (brand name Rituxan© in the US and MabThera© in the EU) is a monoclonal antibody drug which has received regulatory approval for the treatment of RA. A monoclonal antibody is a type of protein made in a laboratory that can find and attach to certain substances in the body. In the case of RA, this binding action reduces the effect of substances in the body which cause RA. Study drug, BI 695500, is being developed as a proposed biosimilar to MabThera© and Rituxan© in terms of composition, strength and administration route as well as safety, purity and potency. Biosimilar products have already been developed and approved in certain indications, and are not new to the pharmaceutical industry. However, there is a clear need for biosimilar development in the field of monocolonal antibodies as a costsaving option for patients and health care systems worldwide. Biosimilars will offer a lower cost treatment option, allowing patients to access/start treatment earlier as well as provide access to these medications in countries where they may not be accessible today. The purpose of the study is to look at the efficacy, pharmacokinetics (PK), and safety of the proposed biosimilar drug, BI 695500, versus rituximab in patients with moderately to severely active rheumatoid arthritis (RA). This is a 48 week, randomized, double-blind, parallel arm, multiple dose, active comparator trial that will have a Worldwide study poluation of approximately 300 participants.

• REC name

  Wales REC 2

• REC reference

  12/WA/0250

• Date of REC Opinion

  14 Sep 2012

• REC opinion

  Favourable Opinion