Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects

Multiple Sclerosis, Relapsing-remitting Clinical Trial

Official title:

A Randomized, Multicenter, Parallel Group, Open-label Study Comparing the Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing Remitting MS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292253
• Other study ID #: 22982
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2006
• Last updated: August 4, 2013
• Start date: January 2001
• Est. completion date: December 2002

Study information

• Verified date: August 2013
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a randomized, multicenter, parallel-group, open-label study comparing the tolerability of Rebif® injections (44 microgram [mcg] administered subcutaneously three times a week) with and without Rebiject™Mini, an auto-injection device in relapsing-remitting multiple sclerosis (MS) subjects. Subjects will be randomly assigned to either one of the two Rebif® groups in a 1:1 ratio on Study Day 1 stratified by center. Subjects will receive a minimum of 3 months of treatment with Rebif® 44 mcg three times a week and will be asked to assess their injection site reactions on a weekly basis. Clinic visit will occur at 1 and 3 months after the initiation of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1883
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Greater than or equal to 18 years of age

• Has relapsing-remitting MS

• Are willing and able to comply with the protocol for the duration of the study

Exclusion Criteria:

• Has significant leukopenia/lymphopenia (white blood cell count less than (<) 0.5 times the lower limit of normal)

• Has elevated liver function tests (aspartate aminotransferase [AST], Alanine transaminase [ALT], or alkaline phosphatase greater than (>) 2 times the upper limit of normal or total bilirubin > 1.5 times the upper limit of normal)

• Has an allergy to human serum albumin or mannitol

• Had treatment with an investigational product or procedure within 3 months

• Has the presence of systemic disease or abnormal laboratory findings that might interfere with subject safety, compliance or evaluation of the condition under study

• Has concomitant use of Avonex®, Betaseron®, Copaxone®, or Novantrone®

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Device:
• Rebif® via Rebiject™Mini
Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with Rebiject™Mini, an auto-injection device for 3 months.
• Rebif® via manual injections
Rebif® will be administered subcutaneously at a dose 44 mcg three times a week with manual injections for 3 months.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
EMD Serono	Merck Serono International SA

References & Publications (1)

Mikol D, Lopez-Bresnahan M, Taraskiewicz S, Chang P, Rangnow J; Rebiject Study Group. A randomized, multicentre, open-label, parallel-group trial of the tolerability of interferon beta-1a (Rebif) administered by autoinjection or manual injection in relaps — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment		Month 3	Yes
Secondary	Number of subjects with any injection site reactions based on physician assessment		Month 3	Yes
Secondary	Percentage of moderate to severe (Grade 3-5) injection site reactions reported per subject based on subject reports		Baseline up to Month 3	Yes
Secondary	Percentage of injection site reactions reported per subject based on subject reports		Baseline up to Month 3	Yes

External Links

•   Full FDA approved prescribing information can be found here
•   Published in Multiple Sclerosis 2005;11:585-591