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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 11 April 2016
Main ID:  EUCTR2013-004622-29-IT
Date of registration: 05/08/2014
Prospective Registration: Yes
Primary sponsor: Biogen Idec Research Limited
Public title: Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects
Scientific title: A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects
Date of first enrolment: 10/11/2014
Target sample size: 540
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004622-29
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Australia Canada Czech Republic Denmark France Germany Italy Spain
Sweden United Kingdom United States
Contacts
Name: N/A   
Address:  Innovation House, 70 Norden Road SL6 4AY Maidenhead, Berkshire United Kingdom
Telephone:
Email: clinicaltrials@biogenidec.com
Affiliation:  Biogen Idec Research Limited
Name: N/A   
Address:  Innovation House, 70 Norden Road SL6 4AY Maidenhead, Berkshire United Kingdom
Telephone:
Email: clinicaltrials@biogenidec.com
Affiliation:  Biogen Idec Research Limited
Key inclusion & exclusion criteria
Inclusion criteria:
Inclusion Criteria for MS Patients:
- Must have a documented diagnosis of relapsing MS (McDonald 2010 Criteria [Polman 2011]) at study screening.
- If the subject is on BRACE at study screening:
• He/she must have been on therapy for at least 12 months, and
• Experienced =1 relapse within the last 6 months prior to study screening with =1 new T1-Gd+ lesion or =2 new T2 lesions on a brain MRI scan performed =6 months prior to study screening, with comparison made to a T2 MRI scan performed up to 18 months before study screening.
- If the subject is DMT naïve at study screening, he/she must have experienced =2 relapses in the 12 months prior to study screening. In addition, they must have had =1 new T1-Gd+ lesion or =2 new T2 lesions on a brain MRI scan performed =6 months prior to study screening, with comparison made to a T2 MRI scan performed up to 18 months prior to study screening.
- Willing to take natalizumab or fingolimod as the only DMTs for the duration of the study.
- Must have an EDSS score from 0 to 5.5 inclusive at study screening.

Inclusion Criteria for Healthy Volunteers:
- Subjects who are generally healthy as demonstrated by physical examination and by medical history, with no history or evidence of major illnesses, diseases, or disorders.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 540
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
Exclusion Criteria for MS Patients:
- History of or positive test result at study screening for human immunodeficiency virus (HIV).
- History or positive test result at study screening for hepatitis C virus (HCV) antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]). Subjects with immunity to hepatitis B from either active vaccination (defined as negative HBsAg, positive hepatitis B surface antibody [HBsAb] and negative HBcAb) or from previous natural infection (defined as negative HBsAg, positive HBsAb immunoglobulin G, and positive HBcAb) are eligible to participate in the study (definitions are based on the United States (US) Centers for Disease Control and Prevention [CDC]’s interpretation of the hepatitis B serology panel).
- Prior treatment with natalizumab or fingolimod
- Diagnosis of Primary Progressive Multiple Sclerosis [PPMS] and/or Secondary Progressive Multiple Sclerosis [SPMS]

-Exclusion Criteria for Healthy Volunteers:
- Claustrophobia sufficient to interfere with generating reliable MRI scans
- History of other major illness including neurological disorders as determined by the Investigator
- Presence of a metal device affected by MRI (e.g., any type of electronic, mechanical or magnetic implant, cardiac pacemaker, aneurysm clips, implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects), which would be a contraindication for MRI


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Multiple Sclerosis (MS)
MedDRA version: 17.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Tysabri®
Product Name: AN100226, BG00002
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 300-

Trade Name: Gilenya
Product Name: Fingolimod
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: fingolimod
CAS Number: 162359-56-0
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Primary Outcome(s)
Main Objective: The primary objective of the study is to assess the effect of natalizumab compared to fingolimod on the evolution of
new on-treatment T1-gadolinium-enhancing (Gd+) lesions to persistent black holes (PBH) over 52 weeks.
Primary end point(s): The primary endpoint of the study is the cumulative number of =6-month confirmed T1-hypointense lesions (i.e., PBH) arising from new on-treatment T1-Gd+ lesions.
Secondary Objective: The secondary objectives of this study are to assess the effect of natalizumab compared to fingolimod on:
• MRI measures of CNS tissue destruction as measured by the number of new T1-Gd+ lesions.
• Various other MRI measures of disease activity.
• No Evidence of Disease Activity (NEDA)
• Relapse on treatment over 52 weeks.
• The change in information processing speed as measured by the Symbol Digit Modalities Test (SDMT).
Timepoint(s) of evaluation of this end point: Weeks 4, 8, 12, 16, 20, 24, 52
Secondary Outcome(s)
Secondary end point(s): The secondary endpoints of this study are the follwoing:
• MRI endpoints:
o Cumulative number of new T1-Gd+ lesions .
o Change in total T1-hypointense and total T2-hyperintense lesion volumes.
o Cumulative number of new or enlarging T2 lesions.
• Proportion of subjects with NEDA according to the following definition:
o No relapses.
o No 12-week confirmed disability progression based on EDSS.*
o No new T1-Gd+ lesions on brain MRI.
o No new or enlarging T2-hyperintense lesions.
• Time to first relapse, cumulative risk of relapses and time to complete recovery from first relapse. **
• Change in information processing speed as measured by the SDMT from baseline to Week 24 and Week 52.

* Increase of 1.0 or more on the EDSS from a baseline score of 1.0 or more, or an increase of 1.5 or more from a baseline score of 0 that was sustained for 12 weeks (progression could not be confirmed during a relapse).
** 12-week confirmed complete Expanded Disability Status Scale (EDSS) recovery from first on-treatment relapse is defined as an EDSS score that is equal to or lower than the last pre-relapse EDSS score and sustained for at least 12 week
Timepoint(s) of evaluation of this end point: Weeks 4, 8, 12, 16, 20, 24, 52
Secondary ID(s)
101MS408
Source(s) of Monetary Support
Biogen Idec Australia Pty Ltd
Biogen Idec MA Inc.
Biogen Idec Research Limited
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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