Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Long-Term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) (REFLEXION)
This study is currently recruiting participants.
Verified by EMD Serono, January 2009
Sponsored by: EMD Serono
Information provided by: EMD Serono
ClinicalTrials.gov Identifier: NCT00813709
  Purpose

REFLEXION is a double-blind (blinding of both investigator and patient) extension of the study 27025 (REFLEX). The purpose of the study is to obtain long-term follow-up data in patients with clinically definite Multiple Scleroris (MS) and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (RNF).


Condition Intervention Phase
Multiple Sclerosis
Clinically Isolated Syndrome
Drug: RNF
Drug: Rebif® New Formulation (RNF)
Phase III

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: Interferons Interferon beta 1a
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: Double-Blind Extension of the Study 27025 (REFLEX) to Obtain Long-Term Follow-up Data in Patients With Clinically Definite MS and Patients With a First Demyelinating Event at High Risk of Converting to MS, Treated With Rebif® New Formulation (REFLEXION)

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Time to conversion to CDMS defined by either a second attack or a sustained increase (greater than or equal to 1.5 points) in the EDSS score (as defined in study 27025 (REFLEX)), from randomization in study 27025 (REFLEX) up to Month 36. [ Time Frame: 36 Months from randomization in study 27025 (REFLEX) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to conversion to CDMS (only at M36); Time to confirmed EDSS progression (≥1.0 point, confirmed during a visit performed 6 months later); MRI endpoints; Other secondary endpoints (PASAT, relapse-free subjects...); Safety endpoints (SAEs,BAbs&Nabs.) [ Time Frame: 36 and 60 months from randomisation in study 27025 (REFLEX) ] [ Designated as safety issue: No ]

Estimated Enrollment: 430
Study Start Date: January 2009
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: RNF
Drug RNF 44 mcg tiw sc
2: Experimental Drug: RNF
Drug RNF 44 mcg ow sc
3: Experimental Drug: RNF
Drug RNF 44 mcg tiw sc (having originally been randomised to placebo in previous study 27025)
4 Drug: Rebif® New Formulation (RNF)
Drug RNF 44 mcg tiw sc for all patients when they reach CDMS

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 CDMS conversion up to Month 36 and up to Month 60 since randomisation in study 27025 (REFLEX). Furthermore, the study is intended to explore whether RNF treatment initiated after the first clinical event versus delayed treatment delays disability (including development of secondary progressive MS) and reduces disease activity (including the annual relapse rate) in the long term (up to Month 36 and up to Month 60 since randomisation in study 27025 (REFLEX)). The study will also assess the long-term safety profile of RNF (up to Month 36 and up to Month 60 since randomisation in study 27025 (REFLEX)).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Reach scheduled End of Study in study 27025 (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. 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 (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner,
  • Subject is willing to follow study procedures,
  • Subject has given written informed consent.

Exclusion Criteria:

  • 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 > 2.5 times upper limit of normal at both Month 24 and at the previous visit (i.e. Month 21) (subjects with > 2.5 times upper limit of normal at Month 24 only are eligible for enrollment and should be managed as per label recommendations until normalisation of the value),
  • Subject has total aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of normal values at both Month 24 and at the previous visit (i.e. Month 21) (subjects with > 2.5 times upper limit of normal at Month 24 only are eligible for enrollment and should be managed as per label recommendations until normalisation 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-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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813709

  Show 72 Study Locations
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Bettina Stubinski, MD Merck Serono S.A. - Geneva
  More Information

Responsible Party: Merck Serono S.A. - Geneva ( Bettina Stubinski, MD )
Study ID Numbers: 28981
Study First Received: December 22, 2008
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00813709  
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Austria: Agency for Health and Food Safety;   Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment;   Bulgaria: Bulgarian Drug Agency;   Canada: Canadian Institutes of Health Research;   Croatia: Ministry of Health and Social Care;   Czech Republic: State Institute for Drug Control;   Estonia: The State Agency of Medicine;   Finland: National Agency for Medicines;   France: Afssaps - French Health Products Safety Agency;   Germany: Federal Institute for Drugs and Medical Devices;   Greece: Ministry of Health and Welfare;   Israel: Ministry of Health;   Italy: Ethics Committee;   Latvia: State Agency of Medicines;   Morocco: Ministry of Public Health;   Poland: Ministry of Health;   Portugal: National Pharmacy and Medicines Institute;   Romania: National Medicines Agency;   Russia: Ministry of Health and Social Development of the Russian Federation;   Saudi Arabia: Ministry of Health;   Serbia and Montenegro: Agency for Drugs and Medicinal Devices;   Slovakia: State Institute for Drug Control;   Spain: Spanish Agency of Medicines;   Turkey: Ministry of Health

Keywords provided by EMD Serono:
Interferon 1-beta
Clinical Definite Multiple Sclerosis

Study placed in the following topic categories:
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferons
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Disease
Pathologic Processes
Immune System Diseases
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009