A Study to Provide RoActemra/Actemra (Tocilzumab) to Patients With Multicentric Castleman's Disease Who Demonstrated Benefit From Previous RoActemra/Actemra Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01183598
First received: August 13, 2010
Last updated: October 6, 2014
Last verified: October 2014

August 13, 2010
October 6, 2014
August 2006
November 2011   (final data collection date for primary outcome measure)
  • Efficacy: Maintenance of hemoglobin >/=10.5 g/dL, of Zubrod Performance Status, and of improvement in fatigue and anorexia as per National Cancer Institute Common Toxicity Criteria (NCI CTC) scales [ Time Frame: until disease progression or significant toxicity occurs ] [ Designated as safety issue: No ]
  • Safety: Adverse events, laboratory parameters, vital signs, electrocardiograms, chest X-rays [ Time Frame: up to 90 days after discontinuation of treatment ] [ Designated as safety issue: No ]
  • Provision of tocilizumab for treatment of Multicentric Castleman's Disease to patients with evidence of clinical benefit in response to tocilizumab [ Time Frame: until disease progression or significant toxicity occurs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01183598 on ClinicalTrials.gov Archive Site
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A Study to Provide RoActemra/Actemra (Tocilzumab) to Patients With Multicentric Castleman's Disease Who Demonstrated Benefit From Previous RoActemra/Actemra Treatment
Provision of Tocilizumab for Patients With Multicentric Castleman's Disease Who Have Demonstrated Benefit From Previous Tocilizumab Treatment

This open-label, single center study will provide RoActemra/Actemra (tocilizumab

) to a maximum of 4 patients with Multicentric Castelman's Disease who have demo nstrated benefit from RoActemra/Actemra in study MRA004US (Chugai Pharma USA) wi thout major toxicities or significant adverse events. Patients will receive thei r most effective maintenance dose until disease progression or significant toxic ity occurs.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Castleman's Disease
Drug: tocilizumab [RoActemra/Actemra]
maintenance dose
Experimental: Single Arm
Intervention: Drug: tocilizumab [RoActemra/Actemra]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
November 2011
November 2011   (final data collection date for primary outcome measure)

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 </= 3

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01183598
WA19847
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP