Rituximab to Treat Hepatitis C-Associated Cryoglobulinemic Vasculitis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Michael C Sneller, MD, National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier:

NCT00029107

First received: January 5, 2002

Last updated: April 10, 2012

Last verified: April 2012

History of Changes

Results First Received: October 26, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Hepatitis C Vasculitis
Intervention:	Drug: Rituximab

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between June 2002 and April 2010, a total of 24 patients were enrolled in the study. Twelve patients randomized to the rituximab group and 12 patients to the control group.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 47 patients were screened for randomization into this study. Eighteen patients did not meet one or more of the above eligibility criteria. Five eligible patients elected not to enroll in the study because of concerns about potential rituximab toxicity. The remaining 24 patients were enrolled in the study and underwent randomization

Reporting Groups

	Description
Immediate Treatment	Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
Standard Therapy	Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.

Participant Flow: Overall Study

	Immediate Treatment	Standard Therapy
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Immediate Treatment	Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
Standard Therapy	Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
Total	Total of all reporting groups

Baseline Measures

	Immediate Treatment	Standard Therapy	Total
Number of Participants [units: participants]	12	12	24
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	12	12	24
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	52 ± 5.6	51 ± 4	51 ± 4.8
Gender [units: participants]
Female	2	4	6
Male	10	8	18
Region of Enrollment [units: participants]
United States	12	12	24

Outcome Measures

1. Primary:

Percent of Patients in Remission [ Time Frame: month 6 ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	6 months
Additional Description	Only adverse events that were grade 3 or greater and were possibly or probably related to the study drug were collected and analyzed for the purposes of this study

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Immediate Treatment	Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
Standard Therapy	Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.

Other Adverse Events

	Immediate Treatment	Standard Therapy
Total, other (not including serious) adverse events
# participants affected / at risk	0/0	0/0

More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was not blinded. In addition, the study was limited to patients who had failed antiviral therapy.

Results Point of Contact:

Name/Title: Michael C Sneller, MD
Organization: NIAID/NIH
phone: 301-496-0491
e-mail: msneller@niaid.nih.gov

Publications:

Ferri C, Greco F, Longombardo G, Palla P, Moretti A, Marzo E, Fosella PV, Pasero G, Bombardieri S. Antibodies to hepatitis C virus in patients with mixed cryoglobulinemia. Arthritis Rheum. 1991 Dec;34(12):1606-10.

Misiani R, Bellavita P, Fenili D, Borelli G, Marchesi D, Massazza M, Vendramin G, Comotti B, Tanzi E, Scudeller G, et al. Hepatitis C virus infection in patients with essential mixed cryoglobulinemia. Ann Intern Med. 1992 Oct 1;117(7):573-7.

Cacoub P, Fabiani FL, Musset L, Perrin M, Frangeul L, Leger JM, Huraux JM, Piette JC, Godeau P. Mixed cryoglobulinemia and hepatitis C virus. Am J Med. 1994 Feb;96(2):124-32.

Publications automatically indexed to this study:

Sneller MC, Hu Z, Langford CA. A randomized controlled trial of rituximab following failure of antiviral therapy for hepatitis C virus-associated cryoglobulinemic vasculitis. Arthritis Rheum. 2012 Mar;64(3):835-42. doi: 10.1002/art.34322.

Responsible Party:	Michael C Sneller, MD, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00029107 History of Changes
Other Study ID Numbers:	020096, 02-I-0096
Study First Received:	January 5, 2002
Results First Received:	October 26, 2011
Last Updated:	April 10, 2012
Health Authority:	United States: Federal Government United States: Institutional Review Board United States: Food and Drug Administration

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