“The RITP study” Protocol version 5

• Research type

  Research Study

• Full title

  Rituximab as second line treatment for ITP: A Multicentre, Randomized, Double blind,Placebo-controlled, Phase III study. “The RITP study”

• IRAS ID

  45361

• Contact name

  Nichola Cooper

• Sponsor organisation

  Rikshospitalet

• Eudract number

  2005-005918-20

• Clinicaltrials.gov Identifier

  NCT00344149

• Research summary

  Immune thrombocytopenic purpura (ITP) is an autoimmune disorder characterized thrombocytopenia. Splenectomy is the standard treatment for patients who fail the first-line treatmet: corticosteroid. Rituximab, has recently emerged as a promising treatment for ITP. Our aim is to determine whether early treatment with Rituximab can result in durable remissions, and consequently, lead to the avoidance of splenectomy in a significant number of patients.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  10/H0304/13

• Date of REC Opinion

  15 Apr 2010

• REC opinion

  Further Information Favourable Opinion