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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01101776




Registration number
NCT01101776
Ethics application status
Date submitted
8/04/2010
Date registered
12/04/2010
Date last updated
13/08/2014

Titles & IDs
Public title
Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting.
Scientific title
Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting
Secondary ID [1] 0 0
701068-522
Universal Trial Number (UTN)
Trial acronym
ReNew
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Interferon beta-1a (Rebif)

Treatment: Drugs: Interferon beta-1a (Rebif)
Interferon beta-1a 44 micrograms (12 MIU) given three times per week (tiw) by subcutaneous injection (SCI). Dose to be reduced to 22 micrograms (6 MIU) tiw by SCI for subjects who cannot tolerate the higher dose.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and type of injection site reactions (ISRs)
Timepoint [1] 0 0
Month 3, 6, 9 and 12
Secondary outcome [1] 0 0
Number of missed injections of Rebif New Formulation since the previous visit
Timepoint [1] 0 0
Month 3, 6, 9 and 12
Secondary outcome [2] 0 0
Reasons for missed injections of Rebif New Formulation since the previous visit
Timepoint [2] 0 0
Month 3, 6, 9 and 12
Secondary outcome [3] 0 0
Changes in quality of life (MusiQoL)
Timepoint [3] 0 0
Baseline visit and at Month 6 and 12
Secondary outcome [4] 0 0
Number and type (telephone, face-to-face, written) of interactions with nurse support
Timepoint [4] 0 0
Month 3, 6, 9 and 12
Secondary outcome [5] 0 0
Relapse rate
Timepoint [5] 0 0
Month 3, 6, 9 and 12.
Secondary outcome [6] 0 0
Proportion of subjects with dose reductions to 22 mcg as a result of tolerability
Timepoint [6] 0 0
Month 3, 6, 9 and 12

Eligibility
Key inclusion criteria
* Ambulatory patients with Multiple Sclerosis who:

1. have experienced two or more relapses within the last 2 years. or
2. are not tolerating their current MS therapy.
* Patients 18 years of age or over.
* Patients with Expanded Disability Status Scale (EDSS) score <6.0.
* Patients who have given informed consent to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with diagnosis of any other form of MS other than relapsing MS.
* Contra-indicated medical conditions for IFN beta-1a as defined in the Product Information i.e: women who are or plan to become pregnant whilst on therapy; subject with severe depressive disorders and/or suicidal ideation and; epileptic subjects with seizures not adequately controlled by treatment
* Subjects with a known hypersensitivity to natural or recombinant interferon beta, mannitol, poloxamer, methionine, sodium acetate buffer or benzyl alcohol.
* Subjects who are pregnant and/or breastfeeding.
* Subjects currently on Rebif New Formulation.
* Subjects currently experiencing a relapse.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Merck Serono Research Site - Bruce
Recruitment hospital [2] 0 0
Merck Serono Research Site - Burwood
Recruitment hospital [3] 0 0
Merck Serono Research Site - Chatswood
Recruitment hospital [4] 0 0
Merck Serono Research Site - Orange
Recruitment hospital [5] 0 0
Merck Serono Research Site - Rozelle
Recruitment hospital [6] 0 0
Merck Serono Research Site - Woollongong
Recruitment hospital [7] 0 0
Merck Serono Research Site - Adelaide
Recruitment hospital [8] 0 0
Merck Serono Research Site - Box Hill
Recruitment hospital [9] 0 0
Merck Serono Research Site - Clayton
Recruitment hospital [10] 0 0
Merck Serono Research Site - Fitzroy
Recruitment hospital [11] 0 0
Merck Serono Research Site - Footscray
Recruitment hospital [12] 0 0
Merck Serono Research Site - Geelong
Recruitment hospital [13] 0 0
Merck Serono Research Site - Heidelberg
Recruitment hospital [14] 0 0
Merck Serono Research Site - Nedlands
Recruitment hospital [15] 0 0
Merck Serono Research Site - Perth
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2134 - Burwood
Recruitment postcode(s) [3] 0 0
2067 - Chatswood
Recruitment postcode(s) [4] 0 0
2800 - Orange
Recruitment postcode(s) [5] 0 0
2039 - Rozelle
Recruitment postcode(s) [6] 0 0
2500 - Woollongong
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5067 - Adelaide
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3168 - Clayton
Recruitment postcode(s) [11] 0 0
3065 - Fitzroy
Recruitment postcode(s) [12] 0 0
3011 - Footscray
Recruitment postcode(s) [13] 0 0
3220 - Geelong
Recruitment postcode(s) [14] 0 0
3084 - Heidelberg
Recruitment postcode(s) [15] 0 0
6009 - Nedlands
Recruitment postcode(s) [16] 0 0
6151 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck KGaA, Darmstadt, Germany
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Serono Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This observational multicentric study is planned to assess the tolerability of Rebif New Formulation in an Australian clinical setting by the incidence of injection site reactions (ISRs). The study will allow the comparison of tolerability data with historical data for both Rebif New and classic formulations, and will do so by using the same pre- specified preferred terms of treatment emergent adverse events as done in historical studies. In addition, the study will analyse whether interaction(s) with a nurse impacts tolerability and the impact of Rebif New Formulation on the patient's Quality of Life.
Trial website
https://clinicaltrials.gov/study/NCT01101776
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lynn Sartori
Address 0 0
Merck Serono Australia Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01101776