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

Roche

Status and phase

Completed

Phase 1

Conditions

Castleman's Disease

Treatments

Drug: tocilizumab [RoActemra/Actemra]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01183598

WA19847

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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