Status:
COMPLETED
Assessment of Patient Use of a New Device: RebiSmart
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono Limited, UK
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Brief Summary
Multiple sclerosis (MS) is a chronic disease which causes inflammation and destruction of the nerves in within the brain and the spinal cord. This disease is one of the most common causes of disabilit...
Eligibility Criteria
Inclusion
- Have relapsing remitting multiple sclerosis
- Between 18 to 65 years old inclusive
- Have been prescribed Rebif for the first time but not yet started treatment
- Rebismart as chosen device
- Be under review by MS nurse
- Having given written informed consent to participate in the study
Exclusion
- Injections of Rebif given by someone other than the patient
- Patients unable to use the Rebismart device due to visual or physical impairment
- Patients unwilling to give informed consent
- Contra-indications to Rebif as defined in the Summary of Product Characteristics (SPC).
- Allergy to the antipyretic analgesics that will be advised as prophylaxis for flu-like symptoms
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01195870
Start Date
July 1 2009
End Date
October 1 2010
Last Update
February 17 2014
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