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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT01183598
• Date of registration: 13/08/2010
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study to Provide RoActemra/Actemra (Tocilzumab) to Patients With Multicentric Castleman's Disease Who Demonstrated Benefit From Previous RoActemra/Actemra Treatment
• Scientific title: Provision of Tocilizumab for Patients With Multicentric Castleman's Disease Who Have Demonstrated Benefit From Previous Tocilizumab Treatment
• Date of first enrolment: August 2006
• Target sample size: 3
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01183598
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Castleman's Disease

Intervention(s)

Drug: tocilizumab [RoActemra/Actemra]

Primary Outcome(s)

Safety: Adverse events, laboratory parameters, vital signs, electrocardiograms, chest X-rays [Time Frame: up to 90 days after discontinuation of treatment]

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]

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]

Secondary ID(s)

WA19847

Source(s) of Monetary Support

Please refer to primary and secondary sponsors