VELVET

• Research type

  Research Study

• Full title

  VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate.

• IRAS ID

  70661

• Contact name

  Mehernoosh Sheriar Irani

• Sponsor organisation

  Nycomed GmbH

• Eudract number

  2010-022378-15

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is a randomised, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in patients with moderate to severe rheumatoid arthritis insufficiently controlled with methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment. The purpose of this trial is to compare 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate.It is planned that approximately 75 sites will be involved in countries in Europe, America, Canada and Latin America. It is planned that 360 patients will be screened and 300 patients will be eligible to participate.The trial comprises a screening phase (4 to 12 weeks prior to first administration of veltuzumab), a 4-week treatment phase (Weeks 1 to 4), a core phase from Week 4 to Week 24 and a follow-up phase from Week 24 to Week 48.Patients will be randomised to one of 4 treatment groups. Depending on the group they are assigned to, they will receive weekly (Days 1, 8, 15 and 22) subcutaneous injections of Veltuzumab or placebo.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  11/LO/0835

• Date of REC Opinion

  18 Aug 2011

• REC opinion

  Further Information Favourable Opinion