Clinical Study Results

• BI 695500 - Lymphoma, Non-Hodgkin

  Clinical Study Number	1301.6
  Study Indication	Lymphoma, Non-Hodgkin
  Product	BI 695500
  Generic Name	BI 695500
  Lab Code
  Clinical Phase	III
  Study Title	A Phase III, randomized, double-blind, multi-center, multi-national trial to evaluate efficacy and safety of BI 695500 versus rituximab as a first-line immunotherapy treatment in patients with low tumor burden follicular lymphoma
  Study Document	Trial statement 1301.6_DR english Trial synopsis 1301.6_DR english

• BI 695500 - Arthritis, Rheumatoid

  Clinical Study Number	1301.1
  Study Indication	Arthritis, Rheumatoid
  Product	BI 695500
  Generic Name	BI 695500
  Lab Code
  Clinical Phase	I/III
  Study 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
  Study Document	Trial statement 1301.1 english Trial synopsis 1301.1_DS english

• BI 695500 - Arthritis, Rheumatoid

  Clinical Study Number	1301.4
  Study Indication	Arthritis, Rheumatoid
  Product	BI 695500
  Generic Name	BI 695500
  Lab Code
  Clinical Phase	III
  Study Title	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial
  Study Document	Trial statement 1301.4 english Trial synopsis 1301.4_DS english

• BI 695500 - Lymphoma, Follicular

  Clinical Study Number	1301.5
  Study Indication	Lymphoma, Follicular
  Product	BI 695500
  Generic Name	BI 695500
  Lab Code	BI 695500
  Clinical Phase	I
  Study Title	A randomized, double-blind, parallel-arm, Phase I study to evaluate pharmacokinetics and pharmacodynamics of BI 695500 vs. rituximab (MabThera®) induction immunotherapy as firstline treatment in patients with low tumor burden follicular lymphoma.
  Study Document	Trial synopsis 1301.5 english

• BI 695500 - Coronary Artery Disease , Lymphoma, Non-Hodgkin

  Clinical Study Number	1301.2
  Study Indication	Coronary Artery Disease ; Lymphoma, Non-Hodgkin
  Product	BI 695500
  Generic Name	BI 695500
  Lab Code	BI 695500
  Clinical Phase	III
  Study Title	A randomized, double-blind, multi-center, multi-national Phase III trial to compare efficacy and safety of BI 695500 plus chemotherapy versus rituximab plus chemotherapy in patients with untreated follicular non- Hodgkin’s lymphoma
  Study Document	Trial statement 1301.2 english