UARK 2005-38: Provision of Tocilizumab for Patients with Multicentric Castleman's Disease who have demonstrated Benefit from previous Tocilizumab Treatment.
Sponsor:
Roche
PI:
Frits van Rhee, M.D., Ph.D.
Phase:
I
Purpose:
This protocol will evaluate whether you continue to obtain clinical benefit from tocilizumab.
Eligibility:
You are qualified to enter this treatment protocol, if you have completed two previous tocilizumab studies and your response determined that tocilizumab treatment is safe and beneficial for you.
Treatment:
If you decide to continue treatment with tocilizumab and the treating doctor says you can continue, you may participate until the drug becomes commercially available for the treatment of Castleman's. Disease in the United States or until the sponsor decides to discontinue the protocol. During this time you will be monitored for safety and assessments of your MCD will be made on average every 12 weeks for the duration of treatment. The treatment staff will tell you when to come in for your treatment visits. You should ask the treatment staff how long your visits will last. When you complete the treatment protocol or if you withdraw at any time, you will need to return for 3 follow-up visits. These visits will be 4, 8 and 12 weeks after your last dose of tocilizumab. This is to make sure that all important information of the long term safety of the treatment is collected. At these visits your doctor will ask you if you have had any changes to your health since your last visit and samples of blood will be taken.