Trial Outcomes & Findings for Rituximab to Treat Hepatitis C-Associated Cryoglobulinemic Vasculitis (NCT NCT00029107)

NCT ID: NCT00029107

Last Updated: 2012-04-16

Results Overview

The primary endpoint was the difference in rate of remission between the 2 arms at 6 months from study entry.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: month 6
• Results posted on: 2012-04-16

Participant Flow

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.

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

Participant milestones

Measure	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.
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rituximab to Treat Hepatitis C-Associated Cryoglobulinemic Vasculitis

Baseline characteristics by cohort

Measure	Immediate Treatment n=12 Participants Patients receive treatment with four weekly infusions of rituximab immediately following randomization.	Standard Therapy n=12 Participants Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	52 years STANDARD_DEVIATION 5.6 • n=5 Participants	51 years STANDARD_DEVIATION 4 • n=7 Participants	51 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: month 6

The primary endpoint was the difference in rate of remission between the 2 arms at 6 months from study entry.

Outcome measures

Measure	Immediate Treatment n=12 Participants Patients receive treatment with four weekly infusions of rituximab immediately following randomization.	Standard Therapy n=12 Participants Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
Percent of Patients in Remission	83 percent of participants Interval 52.0 to 98.0	8 percent of participants Interval 2.0 to 38.0

Adverse Events

Immediate Treatment

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Therapy

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Immediate Treatment n=12 participants at risk Patients receive treatment with four weekly infusions of rituximab immediately following randomization.	Standard Therapy n=12 participants at risk Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
Blood and lymphatic system disorders Leukopenia	8.3% 1/12 • Number of events 1 • 6 months 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	16.7% 2/12 • Number of events 2 • 6 months 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
Blood and lymphatic system disorders thrombocytopenia	8.3% 1/12 • Number of events 1 • 6 months 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	8.3% 1/12 • Number of events 1 • 6 months 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
Hepatobiliary disorders AST elevation > grade 3	25.0% 3/12 • Number of events 4 • 6 months 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	25.0% 3/12 • Number of events 3 • 6 months 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
Infections and infestations Infection	8.3% 1/12 • Number of events 1 • 6 months 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	16.7% 2/12 • Number of events 2 • 6 months 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

Other adverse events

Adverse event data not reported

Additional Information

Michael C Sneller, MD

NIAID/NIH

Phone: 301-496-0491

Email: msneller@niaid.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place