Status:
COMPLETED
12-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis.
Lead Sponsor:
EMD Serono
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The Electronic Device - The RebiSmart™ is an electronic injection device that is being studied for the delivery of Merck Serono's Rebif® New Formulation. The RebiSmart™ device is a stand-alone hand-he...
Eligibility Criteria
Inclusion
- Males and females between 18 and 65 years of age, inclusive
- Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either:
- Post-menopausal or surgically sterile, or
- Using a highly effective method of contraception for the duration of the study. This is defined as a method that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s, sexual abstinence or vasectomised partner.
- Have RMS according to the revised McDonald Criteria 2005
- Have disease duration for at least 3 months
- Are currently receiving RNF 44 mcg sc by Rebiject IITM (RII) tiw and have been consistently on therapy for a minimum of 6 weeks prior to Screening
Exclusion
- Have any disease other than MS that could better explain his/her signs and symptoms
- Receive any other injectable medications on a regular basis during the week prior to the screening period or throughout the duration of the study. The administration of a single injection for treatment or prophylaxis of a condition unrelated to the patient's MS or the patient's RNF therapy (e.g., influenza or pneumococcus vaccination) will be acceptable
- Receive any MS therapy other than Rebif / RNF (e.g., other disease-modifying drug \[DMD\]s: immunomodulatory , immunosuppressive agents or combination therapy) within 12 months prior to study enrolment or at any time during the study
- Receive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days prior to SD1
- Have inadequate liver function, defined by a alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN), or alkaline phosphatase \> 2 x ULN, or total bilirubin \> 2 x ULN if associated with any elevation of ALT or alkaline phosphatase
- Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal
- Have moderate to severe renal impairment
- History of any chronic pain syndrome
- Any visual or physical impairment that precludes the subject self-injecting the treatment using the RebiSmartä
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00735007
Start Date
July 1 2008
Last Update
November 14 2013
Active Locations (6)
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1
US Local Medical Information
Rockland, Massachusetts, United States, 02370
2
Canada, Local Medical Information
Ontario, British Columbia, Quebec, Canada
3
Germany, Local Medical Information
Hamburg, Ulm, Berlin, Erbach, Germany
4
Italy, Local Medical Information
Chieti & Roma, Italy, Italy