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

Phase 1

Completed

• Conditions: Castleman's Disease
• Interventions: Drug: tocilizumab [RoActemra/Actemra]

• Registration Number: NCT01183598
• Lead Sponsor: Hoffmann-La Roche

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 in study MRA004US (Chugai Pharma USA) without major toxicities or significant adverse events. Patients will receive their most effective maintenance dose until disease progression or significant toxicity occurs.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2010-08-13
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-17
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	tocilizumab [RoActemra/Actemra]	-

Primary Outcome Measures

Name	Time	Method
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	until disease progression or significant toxicity occurs
Safety: Adverse events, laboratory parameters, vital signs, electrocardiograms, chest X-rays	up to 90 days after discontinuation of treatment
Provision of tocilizumab for treatment of Multicentric Castleman's Disease to patients with evidence of clinical benefit in response to tocilizumab	until disease progression or significant toxicity occurs