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

Completed · Phase 1

Conditions studied: Castleman's Disease

In brief

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.

Key facts

Study ID

NCT01183598

Run by

Hoffmann-La Roche

People needed

3

Starts

2006-08-01

Expected to finish

2011-11-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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