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Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) (REFLEXION)

Primary Purpose

Multiple Sclerosis, Clinically Isolated Syndrome

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

RNF

Placebo

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Interferon 1-beta, Clinical Definite Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 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 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

RNF 44 mcg thrice weekly

RNF 44 mcg once weekly and placebo

Placebo/RNF 44 mcg thrice weekly

Arm Description

Outcomes

Primary Outcome Measures

Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score up to 36 Months

CDMS was defined by the occurrence of a second attack or relapse over 36 months in participants who presented with clinically isolated syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI) scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. Time to conversion to CDMS was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with CDMS.

Secondary Outcome Measures

Time to Confirmed Expanded Disability Status Scale (EDSS) Progression up to 36 Months

EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. Time to confirmed EDSS progression was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with confirmed EDSS progression.

Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, New Gadolinium Enhanced (Gd+) Lesions and New Time Constant 1 (T1) Lesions Per Participant Per Scan at Month 36

Number of CUA lesions, new T2 lesions, new Gd+ lesions and new T1 lesions were measured by using MRI scans.

Change From Baseline in Time Constant 1 (T1) Hypointense Lesion Volume and Time Constant 2 (T2) Lesion Volume at Month 36

Change from baseline in lesion volume was measured by using MRI scans for T1 hypointense lesions and T2 lesions at Month 36

Percent Change From Baseline in Brain Volume at Month 36

Percent change in brain volume was measured by using MRI scans.

Percentage of Participants With Conversion to McDonald Multiple Sclerosis (MS) up to 36 Months

The McDonald criteria use dissemination in time and space established by MRI findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new T2 or Gd+ lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.

Change From Baseline in Paced Auditory Serial Addition Test 3 (PASAT-3) Score at Month 36

The Paced Auditory Serial Addition Test (PASAT) is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Score ranges from '0-60'. Higher scores reflect better neurological function and a positive change from baseline indicates improvement.

Percentage of Relapse-Free Participants at Month 36

A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.

Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 36

EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS score at Month 36 was calculated as EDSS score at Month 36 minus EDSS score at baseline.

Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Month 36

The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3).

Numbers of Participants With Binding Antibodies (BAb) and Neutralizing Antibody (NAb) at Month 36

BAbs are all antibodies which are capable of binding to the investigational drug molecule (RNF) irrespective of their binding site. NAbs are defined as a subgroup of BAbs which bind to the active sites of the RNF and therefore neutralize its potency. NAbs were detected using a viral cytopathic assay. BAbs were measured by using an ELISA (Enzyme-linked immunosorbent assay).

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation

An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.

CDMS was defined by the occurrence of a second attack or relapse over 60 months in participants who presented with clinically isolated syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI) scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. Time to conversion to CDMS was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with CDMS.

Time to Confirmed Expanded Disability Status Scale (EDSS) Progression up to 60 Months

Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, New Gadolinium Enhanced (Gd+) Lesions and New T1 Lesions Per Participant Per Scan at Month 60

Number of CUA lesions, new T2 lesions, new Gd+ Lesions and new T1 lesions were measured by using MRI scans.

Change From Baseline in Time Constant 1 (T1) Hypointense Volume, and Time Constant 2 (T2) Lesion Volume at Month 60

Change from baseline in lesion volume was measured by using MRI scans for T1 hypointense lesions and T2 lesions.

Percent Change From Baseline in Brain Volume at Month 60

Percent Change in brain volume was measured by using MRI scans.

Percentage of Participants With Conversion to McDonald Multiple Sclerosis (MS) at Month 60

Change From Baseline in Paced Auditory Serial Addition Test 3 (PASAT-3) Score at Month 60

The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Score ranges from '0-60'. Higher scores reflect better neurological function and a positive change from baseline indicates improvement.

Percentage of Relapse-Free Participants at Month 60

Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 60

EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS score at Month 60 was calculated as EDSS score at Month 60 minus EDSS score at baseline.

Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Month 60

Numbers of Participants With Binding Antibodies (BAb) and Neutralizing Antibody (NAb) at Month 60

BAbs are all antibodies which are capable of binding to the RNF irrespective of their binding site. NAbs are defined as a subgroup of BAbs which bind to the active sites of the RNF and therefore neutralize its potency. NAbs were detected using a viral cytopathic assay. BAbs were measured by using an ELISA.

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation

Full Information

NCT ID

NCT00813709

First Posted

December 22, 2008

Last Updated

January 25, 2017

Sponsor

Merck KGaA, Darmstadt, Germany

1. Study Identification

Unique Protocol Identification Number

NCT00813709

Brief Title

Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)

Acronym

REFLEXION

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck KGaA, Darmstadt, Germany

4. Oversight

5. Study Description

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 (MS) and subjects with a first demyelinating event at high risk of converting to MS, treated with fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF).

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 Sclerosis (CDMS) conversion up to Month 36 and up to Month 60 since randomization 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 [ARR]) in the long term (up to Month 36 and up to Month 60 since randomization 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 randomization in Study 27025 (REFLEX).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Clinically Isolated Syndrome

Keywords

Interferon 1-beta, Clinical Definite Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

402 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RNF 44 mcg thrice weekly

Arm Type

Active Comparator

Arm Title

RNF 44 mcg once weekly and placebo

Arm Type

Active Comparator

Arm Title

Placebo/RNF 44 mcg thrice weekly

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

RNF

Other Intervention Name(s)

Rebif®

Intervention Description

Single dose of RNF will be administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.

Intervention Type

Drug

Intervention Name(s)

RNF

Other Intervention Name(s)

Rebif®

Intervention Description

Single dose of RNF will be administered subcutaneously once weekly at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.

Intervention Type

Drug

Intervention Name(s)

RNF

Other Intervention Name(s)

Rebif®

Intervention Description

Participants who were initially randomized in Study 27025 (REFLEX) to the placebo treatment group will be switched to single dose of RNF administered subcutaneously three times weekly at least 48 hours apart at a dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single dose matching placebo will be administered subcutaneously twice weekly. Placebo is supplied as a transparent, sterile solution for injection in pre-filled syringes matching the RNF pre-filled syringes, each containing 0.5 milliliter (mL).

Primary Outcome Measure Information:

Title

Description

Time Frame

Baseline (Day 1 of Study 27025) up to 36 Months

Secondary Outcome Measure Information:

Title

Time to Confirmed Expanded Disability Status Scale (EDSS) Progression up to 36 Months

Description

Time Frame

Baseline (Day 1 of Study 27025) up to 36 Months

Title

Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, New Gadolinium Enhanced (Gd+) Lesions and New Time Constant 1 (T1) Lesions Per Participant Per Scan at Month 36

Description

Number of CUA lesions, new T2 lesions, new Gd+ lesions and new T1 lesions were measured by using MRI scans.

Time Frame

Month 36

Title

Change From Baseline in Time Constant 1 (T1) Hypointense Lesion Volume and Time Constant 2 (T2) Lesion Volume at Month 36

Description

Change from baseline in lesion volume was measured by using MRI scans for T1 hypointense lesions and T2 lesions at Month 36

Time Frame

Baseline (Day 1 of Study 27025), Month 36

Title

Percent Change From Baseline in Brain Volume at Month 36

Description

Percent change in brain volume was measured by using MRI scans.

Time Frame

Baseline (Day 1 of Study 27025), Month 36

Title

Percentage of Participants With Conversion to McDonald Multiple Sclerosis (MS) up to 36 Months

Description

Time Frame

Baseline (Day 1 of Study 27025) up to CDMS conversion and/or up to 36 Months

Title

Change From Baseline in Paced Auditory Serial Addition Test 3 (PASAT-3) Score at Month 36

Description

Time Frame

Baseline (Day of Study 27025), Month 36

Title

Percentage of Relapse-Free Participants at Month 36

Description

Time Frame

Month 36

Title

Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 36

Description

Time Frame

Baseline (Day of Study 27025), Month 36

Title

Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Month 36

Description

Time Frame

Baseline (Day 1 of Study 27025), Month 36

Title

Numbers of Participants With Binding Antibodies (BAb) and Neutralizing Antibody (NAb) at Month 36

Description

Time Frame

Month 36

Title

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation

Description

Time Frame

Month 24 up to Month 36 (DB treatment period for study 28981 (REFLEXION)

Title

Description

Time Frame

Baseline (Day 1 of Study 27025) up to 60 Months

Title

Time to Confirmed Expanded Disability Status Scale (EDSS) Progression up to 60 Months

Description

Time Frame

Baseline (Day 1 of Study 27025) up to 60 Months

Title

Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, New Gadolinium Enhanced (Gd+) Lesions and New T1 Lesions Per Participant Per Scan at Month 60

Description

Number of CUA lesions, new T2 lesions, new Gd+ Lesions and new T1 lesions were measured by using MRI scans.

Time Frame

Month 60

Title

Change From Baseline in Time Constant 1 (T1) Hypointense Volume, and Time Constant 2 (T2) Lesion Volume at Month 60

Description

Change from baseline in lesion volume was measured by using MRI scans for T1 hypointense lesions and T2 lesions.

Time Frame

Baseline (Day 1 of Study 27025), Month 60

Title

Percent Change From Baseline in Brain Volume at Month 60

Description

Percent Change in brain volume was measured by using MRI scans.

Time Frame

Baseline (Day 1 of Study 27025), Month 60

Title

Percentage of Participants With Conversion to McDonald Multiple Sclerosis (MS) at Month 60

Description

Time Frame

Month 60

Title

Change From Baseline in Paced Auditory Serial Addition Test 3 (PASAT-3) Score at Month 60

Description

Time Frame

Baseline (Day 1 of Study 27025), Month 60

Title

Percentage of Relapse-Free Participants at Month 60

Description

Time Frame

Month 60

Title

Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 60

Description

Time Frame

Baseline (Day 1 of Study 27025), Month 60

Title

Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Month 60

Description

Time Frame

Baseline (Day 1 of Study 27025), Month 60

Title

Numbers of Participants With Binding Antibodies (BAb) and Neutralizing Antibody (NAb) at Month 60

Description

Time Frame

Month 60

Title

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation

Description

Time Frame

Month 24 up to Month 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Responsible

Organizational Affiliation

Merck Serono S.A., Geneva

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Mendoza

Country

Argentina

Facility Name

Research Site

City

Graz

Country

Austria

Facility Name

Research Site

City

Brugge

Country

Belgium

Facility Name

Research Site

City

Leuven

Country

Belgium

Facility Name

Research Site

City

Pleven

Country

Bulgaria

Facility Name

Research Site

City

Rousse

Country

Bulgaria

Facility Name

Research Site

City

Shumen

Country

Bulgaria

Facility Name

Research Site

City

Sofia

Country

Bulgaria

Facility Name

Research Site

City

Varna

Country

Bulgaria

Facility Name

Research Site

City

Ontario

Country

Canada

Facility Name

Research Site

City

Victoria British Columbia

Country

Canada

Facility Name

Research Site

City

Karlovac

Country

Croatia

Facility Name

Research Site

City

Osijek

Country

Croatia

Facility Name

Research Site

City

Rijeka

Country

Croatia

Facility Name

Research Site

City

Split

Country

Croatia

Facility Name

Research Site

City

Zagreb

Country

Croatia

Facility Name

Research Site

City

Hradec Kralove

Country

Czech Republic

Facility Name

Research Site

City

Olomouc

Country

Czech Republic

Facility Name

Research Site

City

Prague

Country

Czech Republic

Facility Name

Research Site

City

Tallinn

Country

Estonia

Facility Name

Research Site

City

Tartu

Country

Estonia

Facility Name

Research Site

City

Oulu

Country

Finland

Facility Name

Research Site

City

Paris

Country

France

Facility Name

Research Site

City

Poissy Cedex

Country

France

Facility Name

Research Site

City

Hannover

Country

Germany

Facility Name

Research Site

City

Henningsforf

Country

Germany

Facility Name

Research Site

City

Athens

Country

Greece

Facility Name

Research Site

City

Safed

Country

Israel

Facility Name

Research Site

City

Tel-Hashomer

Country

Israel

Facility Name

Research Site

City

Milano

Country

Italy

Facility Name

Research Site

City

Padova

Country

Italy

Facility Name

Research Site

City

Riga

Country

Latvia

Facility Name

Research Site

City

Beirut

Country

Lebanon

Facility Name

Research Site

City

Rabat

Country

Morocco

Facility Name

Research Site

City

Bialystok

Country

Poland

Facility Name

Research Site

City

Lodz

Country

Poland

Facility Name

Research Site

City

Warsaw

Country

Poland

Facility Name

Research Site

City

Wroclaw

Country

Poland

Facility Name

Research Site

City

Lisbon

Country

Portugal

Facility Name

Research Site

City

Bucharest

Country

Romania

Facility Name

Research Site

City

Iasi

Country

Romania

Facility Name

Research Site

City

Targu-Mures

Country

Romania

Facility Name

Research Site

City

Timisoara

Country

Romania

Facility Name

Research Site

City

Ekaterinburg

Country

Russian Federation

Facility Name

Research Site

City

Moscow

Country

Russian Federation

Facility Name

Research Site

City

Novgorod

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

Country

Russian Federation

Facility Name

Research Site

City

Samara

Country

Russian Federation

Facility Name

Research Site

City

Saratov

Country

Russian Federation

Facility Name

Reserch Site

City

Belgrade

Country

Serbia

Facility Name

Research Site

City

Nis

Country

Serbia

Facility Name

Research Site

City

Presov

Country

Slovakia

Facility Name

Research Site

City

Barcelona

Country

Spain

Facility Name

Research Site

City

Bilbao

Country

Spain

Facility Name

Research Site

City

Madrid

Country

Spain

Facility Name

Research Site

City

Seville

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

28039317

Citation

Comi G, De Stefano N, Freedman MS, Barkhof F, Uitdehaag BM, de Vos M, Marhardt K, Chen L, Issard D, Kappos L. Subcutaneous interferon beta-1a in the treatment of clinically isolated syndromes: 3-year and 5-year results of the phase III dosing frequency-blind multicentre REFLEXION study. J Neurol Neurosurg Psychiatry. 2017 Apr;88(4):285-294. doi: 10.1136/jnnp-2016-314843. Epub 2016 Dec 30.

Results Reference

derived

Learn more about this trial

Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)

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Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) (REFLEXION)

Multiple Sclerosis, Clinically Isolated Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial