Provision of Tocilizumab for Patients With Multicentric Castleman's Disease Who Have Demonstrated Benefit From Previous Tocilizumab Treatment
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Castleman's Disease
Both
Castleman's Disease
Trial Information
Provision of Tocilizumab for Patients With Multicentric Castleman's Disease Who Have Demonstrated Benefit From Previous Tocilizumab Treatment
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Provision of tocilizumab for treatment of Multicentric Castleman's Disease to patients with evidence of clinical benefit in response to tocilizumab
Outcome Time Frame:
until disease progression or significant toxicity occurs
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
WA19847
NCT ID:
NCT01183598
Start Date:
August 2006
Completion Date:
November 2011
Related Keywords:
- Castleman's Disease
- Giant Lymph Node Hyperplasia
Name | Location |
|---|---|
| Little Rock, Arkansas 72205-7199 |
