Status:
COMPLETED
A Study to Provide RoActemra/Actemra (Tocilzumab) to Patients With Multicentric Castleman's Disease Who Demonstrated Benefit From Previous RoActemra/Actemra Treatment
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Castleman's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This open-label, single center study will provide RoActemra/Actemra (tocilizumab) to a maximum of 4 patients with Multicentric Castelman's Disease who have demonstrated benefit from RoActemra/Actemra ...
Eligibility Criteria
Inclusion
- Adult patients, \>/= 18 years of age
- Evidence of improvement of one or more clinical benefit criteria with acceptable tolerability to RoActemra/Actemra in Protocol MRA001US, maintained clinical benefit in MRA004US, and completion of MRA004US
- Life expectancy \> 12 weeks
- Zubrod performance status \</= 3
Exclusion
- Serious toxicity including anaphylactic reactions to tocilizumab during the MRA004US trial
- Any treatment for Multicentric Castleman's Disease except for corticosteroids within 2 weeks prior to Day 1
- Active infection requiring iv antibiotics for \> 1 month and not resolving at least 1 week prior to Day 1; iv antibiotics prophylaxis for infections of implanted venous access portals is allowed
- Active viral infection within 28 days prior to Day 1
- Treatment with any investigational agent other than RoActemra/Actemra within 30 days prior to baseline
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01183598
Start Date
August 1 2006
End Date
November 1 2011
Last Update
November 2 2016
Active Locations (1)
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1
Little Rock, Arkansas, United States, 72205-7199