A Study to Provide RoActemra/Actemra (Tocilzumab) to Patients With Multicentric Castleman's Disease Who Demonstrated Benefit From Previous RoActemra/Actemra Treatment
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ClinicalTrials.gov Identifier: NCT01183598 |
Recruitment Status :
Completed
First Posted : August 17, 2010
Last Update Posted : November 2, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Castleman's Disease | Drug: tocilizumab [RoActemra/Actemra] | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Provision of Tocilizumab for Patients With Multicentric Castleman's Disease Who Have Demonstrated Benefit From Previous Tocilizumab Treatment |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | November 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Single Arm |
Drug: tocilizumab [RoActemra/Actemra]
maintenance dose |
- 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 ]
- Safety: Adverse events, laboratory parameters, vital signs, electrocardiograms, chest X-rays [ Time Frame: 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 [ Time Frame: until disease progression or significant toxicity occurs ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183598
United States, Arkansas | |
Little Rock, Arkansas, United States, 72205-7199 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01183598 |
Other Study ID Numbers: |
WA19847 |
First Posted: | August 17, 2010 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Castleman Disease Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |