Study Stopped
Business Decision
Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants
REVEAL
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
2 other identifiers
interventional
111
9 countries
42
Brief Summary
The primary objective of this 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. The secondary objectives of this study in this study population are to assess the effect of natalizumab compared to fingolimod on: magnetic resonance imaging (MRI) measures of central nervous system (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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2014
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2014
CompletedFirst Submitted
Initial submission to the registry
January 15, 2015
CompletedFirst Posted
Study publicly available on registry
January 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2016
CompletedResults Posted
Study results publicly available
June 9, 2017
CompletedJune 9, 2017
May 1, 2017
1.5 years
January 15, 2015
May 17, 2017
May 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative Number of ≥ 6-Month Confirmed T1-Hypointense Lesions Arising From New On-Treatment T1-Gadolinium-Enhancing (Gd+) Lesions
Up to Week 52
Secondary Outcomes (10)
Cumulative Number of New T1-Gd+ Lesions
Baseline, Week 4, Week 12, Week 24
Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 24
Baseline, Week 24
Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 52
Baseline, Week 52
Cumulative Number of New or Enlarging T2 Lesions
Baseline, Week 24
Proportion of Participants With No Evidence of Disease Activity (NEDA)
Up to Week 52
- +5 more secondary outcomes
Study Arms (2)
natalizumab
EXPERIMENTALOpen-label natalizumab 300 mg IV every 4 weeks (Q4W)
fingolimod
ACTIVE COMPARATOROpen-label fingolimod 0.5 mg once daily orally
Interventions
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Eligibility Criteria
You may qualify if:
- Must have a documented diagnosis of relapsing MS (McDonald 2010 Criteria) at study screening with EDSS score from 0.0 to 5.5.
- If the subject is on Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera, and Aubagio (BRACE-TA) at study screening:
- He/she must have been on therapy for at least 6 months (unless experiencing highly active disease), have at least 9 T2-hyperintense lesions on a brain MRI scan, and have experienced ≥1 relapse within the last 6 months prior to study screening with ≥1 new T1-Gd+ lesion on a brain MRI scan performed ≤6 months prior to study screening 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 has highly active disease, regardless of whether they are disease-modifying therapy (DMT)-naïve or had previous exposure to Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera, and Aubagio (BRACE-TA), they must have had ≥2 disabling relapses in the 12 months prior to study screening and either ≥1 new T1-Gd+ lesion on a brain MRI scan performed ≤6 months prior to study screening 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
You may not qualify if:
- Diagnosis of Primary Progressive Multiple Sclerosis and/or Secondary Progressive Multiple Sclerosis.
- History or positive test result at study screening for human immunodeficiency virus (HIV), 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 \[HBcAb\]).
- Prior treatment with natalizumab or fingolimod.
- History of or known active malignant disease, including solid tumors and hematologic malignancies (subjects with cutaneous basal and squamous cell carcinoma that has been completely excised and considered cured prior to study screening remain eligible).
- History of opportunistic infections or any clinically significant major disease, as determined by the Investigator.
- A clinically significant infectious illness (e.g., pneumonia, septicemia) within the 1 month prior to study screening.
- History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to study screening.
- Prior history of immunosuppressant use (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab), or exposure to intravenous immunoglobulin (IGIV), monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins in the last 12 months prior to study screening.
- History of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure in last 6 months.
- Treatment with Class Ia (e.g., procainamide, quinidine, ajmaline, disopyramide) or Class III (amiodarone, bretylium, dofelitide, sotalol, ibulitide, azilimide) anti-arrhythmic drugs.
- Concurrent therapy with drugs that slow heart rate (e.g., beta-blockers, heart-rate lowering calcium channel blockers such as diltiazem or verapamil, or digoxin).
- Hypertension not controlled with prescribed medications.
- History of severe respiratory disease, pulmonary fibrosis or class III or IV chronic obstructive pulmonary disease.
- The use of live or live attenuated vaccination within 8 weeks of study screening.
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (42)
Research Site
Aurora, Colorado, 80045, United States
Research Site
Colorado Springs, Colorado, 80907, United States
Research Site
Port Charlotte, Florida, 33952, United States
Research Site
Atlanta, Georgia, 30327, United States
Research Site
Des Moines, Iowa, 50314, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Knoxville, Tennessee, 37922, United States
Research Site
Round Rock, Texas, 78681, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Seattle, Washington, 98122, United States
Research Site
Tacoma, Washington, 98405, United States
Research Site
Milwaukee, Wisconsin, 53215, United States
Research Site
Camperdown, New South Wales, 2050, Australia
Research Site
New Lambton Heights, New South Wales, 2305, Australia
Research Site
Heidelberg, Victoria, 3084, Australia
Research Site
Brno, 625 00, Czechia
Research Site
Brno, 656 91, Czechia
Research Site
Hradec Králové, 500 05, Czechia
Research Site
Jihlava, 58633, Czechia
Research Site
Ostrava - Poruba, 708 52, Czechia
Research Site
Pardubice, 532 03, Czechia
Research Site
Prague, 150 06, Czechia
Research Site
Teplice, 415 01, Czechia
Research Site
Nîmes, Gard, 30029, France
Research Site
Libourne, Gironde, 33505, France
Research Site
Toulouse, Haute Garonne, 31059, France
Research Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Research Site
Erbach im Odenwald, Hesse, 64711, Germany
Research Site
Gianicolense, Roma, 87-00151, Italy
Research Site
Roma, 00189, Italy
Research Site
El Palmar, Murcia, 30120, Spain
Research Site
Málaga, Málaga, 29010, Spain
Research Site
Vigo, Pontevedra, 36204, Spain
Research Site
Santa Cruz de Tenerife, Tenerife, 38010, Spain
Research Site
Barcelona, 08035, Spain
Research Site
Girona, 17007, Spain
Research Site
Madrid, 28006, Spain
Research Site
Seville, E 41009, Spain
Research Site
Gothenburg, 41345, Sweden
Research Site
Stockholm, 17176, Sweden
Research Site
London, Greater London, SE5 9NU, United Kingdom
Research Site
Glasgow, Strathclyde, G51 4TF, United Kingdom
Related Publications (1)
Butzkueven H, Licata S, Jeffery D, Arnold DL, Filippi M, Geurts JJ, Santra S, Campbell N, Ho PR; REVEAL Investigators. Natalizumab versus fingolimod for patients with active relapsing-remitting multiple sclerosis: results from REVEAL, a prospective, randomised head-to-head study. BMJ Open. 2020 Oct 20;10(10):e038861. doi: 10.1136/bmjopen-2020-038861.
PMID: 33082194DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Study Medical Director
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2015
First Posted
January 21, 2015
Study Start
November 30, 2014
Primary Completion
May 18, 2016
Study Completion
May 18, 2016
Last Updated
June 9, 2017
Results First Posted
June 9, 2017
Record last verified: 2017-05