GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®

Number of Patients Experiencing Anaphylactic Reactions

2006 NIAID/FAAN\* criteria were used for identification of anaphylactic reactions within 24h of each study drug infusion. For patients with no history of infusion-related reactions during their previous treatments with rituximab, symptoms/signs in at least 2 out of 4 organ systems: * Skin/mucosal tissue * Respiratory organs * Drop of systolic blood pressure (\<90 mmHg or variance from baseline \>30%) or associated symptoms * Gastrointestinal organs were defined as an anaphylactic reaction. The same criteria were also applied to patients with history of infusion-related reactions during their previous treatments with rituximab. In addition, if these patients experienced only a rapid drop in systolic blood pressure (\<90 mmHg or variance from baseline \>30%), this was defined as an anaphylactic reaction disregarding involvement of other organ systems. \* NIAID - National Institute of Allergy and Infectious Diseases FAAN - Food Allergy and Anaphylaxis Network

Time frame: Within 24 hours of each study drug infusion: on Day 1 and Day 14

Number of Patients Experiencing Hypersensitivity Reactions

The standardized MedDRA query (SMQ) - Hypersensitivity reactions (SMQ 20000214) was used for the identification of hypersensitivity reactions overall from first infusion in the adverse event database.

Time frame: 24 weeks study duration

Immunogenicity

Number of patients tested positive for anti-drug-antibodies (ADA) post-randomization. Patients with negative ADA results at screening and at least one evaluable post-randomization ADA assessment are included in the analysis

Time frame: 24 weeks study duration

Number of Patients Experiencing Potential Infusion-Related Reactions

Patients, experienced infusion related reactions repeatedly (i.e. during the first and second infusion) are counted only once in the overall line.

Time frame: On the day of and on the day after each study drug infusion (e.g. on study day 1 and 2 for the 1st study drug infusion and on study day 14 and 15 for the 2nd study drug infusion, if the second drug infusion was given on study day 14)