Status:
COMPLETED
Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Multiple Sclerosis
Clinically Isolated Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
REFLEXION is a double blind extension of the study 27025 (NCT00404352) (REFLEX). The purpose of the study is to obtain long-term follow-up data in subjects with clinically definite multiple sclerosis ...
Detailed Description
The objective of the study is to investigate whether RNF treatment initiated after the first clinical event versus delayed treatment results in the prolongation of time to Clinically Definite Multiple...
Eligibility Criteria
Inclusion
- Reach scheduled end of study in Study 27025 (REFLEX) (completion of 24 months participation)
- Medical assessment by the Investigator/treating physician from study 27025 that there is no objection to the subject's participation in this extension trial considering the medical experience from Study 27025 (REFLEX). Special attention should be given to laboratory abnormalities and clinically significant liver, renal and bone-marrow dysfunction
- If female, subject must:
- be neither pregnant nor breast-feeding, nor attempting to conceive
- use a highly effective method of contraception. A highly effective method of contraception is defined as those which result in a low failure rate (that is \[i.e.\] less than 1 percent \[%\] per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner
- Subject is willing to follow study procedures
- Subject has given written informed consent
Exclusion
- Subject has any disease other than MS that could better explain the subject's signs and symptoms
- Subject has a primary progressive course of MS
- Subject has total bilirubin greater than 2.5 times upper limit of normal (ULN) at both Month 24 and at the previous visit (i.e. Month 21) (subjects with greater than 2.5 times ULN at Month 24 only are eligible for enrollment and should be managed as per label recommendations until normalization of the value)
- Subject has total aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase (ALP) greater than 2.5 times the ULN values at both Month 24 and at the previous visit (i.e. Month 21) (subjects with greater than 2.5 times ULN at Month 24 only are eligible for enrollment and should be managed as per label recommendations until normalization of the value)
- Subject suffers from another current autoimmune disease
- Subject suffers from major medical or psychiatric illness (including history of, or current, severe depressive disorders and/or suicidal ideation) that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
- Subject has a history of seizures not adequately controlled by treatment
- Subject has cardiac disease, such as angina, congestive heart failure or arrhythmia
- Subject has a known allergy to IFN-beta or the excipient(s) of the study medication
- Subject has any condition that could interfere with the MRI evaluation
- Subject has a known allergy to gadolinium-diethylene triamine pentaacetic acid (DTPA)
- Subject has a history of alcohol or drug abuse
- Subject has previously participated in this study
- Subject has moderate to severe renal impairment
- Subject is pregnant or lactating
- Subject has any medical, psychiatric or other conditions that compromise his/her ability to understand the subject information, to give informed consent, to comply with the study protocol, or to complete the study
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00813709
Start Date
December 1 2008
End Date
September 1 2013
Last Update
March 8 2017
Active Locations (57)
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1
Research Site
Mendoza, Argentina
2
Research Site
Graz, Austria
3
Research Site
Bruges, Belgium
4
Research Site
Leuven, Belgium