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Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing-Remitting Multiple Sclerosis

Intervention: natalizumab (Drug); fingolimod (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

Overall contact:
Biogen, Email: clinicaltrials@biogen.com

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).

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Cumulative number of ≥6-month confirmed T1-hypointense lesions arising from new on-treatment T1-Gd+ lesions

Secondary outcome:

Cumulative number of new T1-Gd+ lesions

Change in total T1-hypointense and total T2-hyperintense lesion volumes

Cumulative number of new or enlarging T2 lesions

Proportion of participants with NEDA

Time to first relapse

Cumulative risk of relapse

Time to complete recovery from first relapse

Change in information processing speed as measured by SDMT

Detailed description: This study also includes a Diffusion Tensor Imaging (DTI) sub-study that includes healthy volunteers. Healthy volunteers will not receive any study medication.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Key Inclusion Criteria for MS Patients:

- 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 Key Exclusion Criteria for MS Patients:

- 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.

Key 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.

- Subjects of childbearing potential must practice effective contraception and be

willing and able to continue contraception for duration of the study.

- History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior

to study screening. Key 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.

- Women who are currently pregnant or breastfeeding, or who have a positive pregnancy

test result at screening. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Locations and Contacts

Biogen, Email: clinicaltrials@biogen.com

Research Site, Brno 625 00, Czech Republic; Recruiting

Research Site, Brno 656 91, Czech Republic; Recruiting

Research Site, Hradec Kralove 500 05, Czech Republic; Recruiting

Research Site, Jihlava 58633, Czech Republic; Recruiting

Research Site, Olomouc 775 20, Czech Republic; Recruiting

Research Site, Ostrava - Poruba 708 52, Czech Republic; Recruiting

Research Site, Pardubice 532 03, Czech Republic; Recruiting

Research Site, Praha 5 150 06, Czech Republic; Recruiting

Research Site, Teplice 415 01, Czech Republic; Recruiting

Research Site, Aarhus C 8000, Denmark; Recruiting

Research Site, Sønderborg 6400, Denmark; Not yet recruiting

Research Site, Pau 64046, France; Recruiting

Research Site, Berlin 10117, Germany; Not yet recruiting

Research Site, Cagliari 09126, Italy; Not yet recruiting

Research Site, Genova 16132, Italy; Recruiting

Research Site, Messina 98121, Italy; Not yet recruiting

Research Site, Milano 20132, Italy; Recruiting

Research Site, Napoli 80131, Italy; Not yet recruiting

Research Site, Napoli 80138, Italy; Recruiting

Research Site, Roma 00189, Italy; Recruiting

Research Site, Barcelona 08003, Spain; Recruiting

Research Site, Barcelona 08035, Spain; Recruiting

Research Site, Cordoba 14011, Spain; Recruiting

Research Site, Girona 17007, Spain; Recruiting

Research Site, Leon 24071, Spain; Recruiting

Research Site, Madrid 28006, Spain; Not yet recruiting

Research Site, Pontevedra 36071, Spain; Recruiting

Research Site, Sevilla E 41009, Spain; Recruiting

Research Site, Valencia 46026, Spain; Recruiting

Research Site, Zaragoza 50009, Spain; Recruiting

Research Site, Göteborg 41345, Sweden; Recruiting

Research Site, Helsingborg 25187, Sweden; Not yet recruiting

Research Site, Stockholm 14186, Sweden; Not yet recruiting

Research Site, Stockholm 17176, Sweden; Recruiting

Research Site, Freiburg, Baden Wuerttemberg 79106, Germany; Recruiting

Research Site, Tuebingen, Baden Wuerttemberg 72076, Germany; Not yet recruiting

Research Site, Palma de Mallorca, Baleares 07010, Spain; Recruiting

Research Site, Erlangen, Bayern 91054, Germany; Not yet recruiting

Research Site, Neuburg, Bayern 86633, Germany; Recruiting

Research Site, Marseille cedex 5, Bouches-du-Rhône 13385, France; Recruiting

Research Site, Aurora, Colorado 80045, United States; Recruiting

Research Site, Colorado Springs, Colorado 80907, United States; Recruiting

Research Site, Maitland, Florida 32715, United States; Recruiting

Research Site, Port Charlotte, Florida 33952, United States; Recruiting

Research Site, Nimes, Gard 30029, France; Recruiting

Research Site, Atlanta, Georgia 30327, United States; Recruiting

Research Site, Bordeaux Cedex, Gironde 33000, France; Recruiting

Research Site, Libourne Cedex, Gironde 33505, France; Not yet recruiting

Research Site, London, Greater London W6 8RF, United Kingdom; Recruiting

Research Site, London, Greater London SE5 9NU, United Kingdom; Recruiting

Research Site, London, Greater London E1 1BB, United Kingdom; Recruiting

Research Site, Toulouse cedex 9, Haute Garonne 31059, France; Recruiting

Research Site, Erbach, Hessen 64711, Germany; Recruiting

Research Site, Chicago, Illinois 60612, United States; Recruiting

Research Site, Des Moines, Iowa 50314, United States; Recruiting

Research Site, Santiago de Compostela, La Coruña 15706, Spain; Recruiting

Research Site, Baton Rouge, Louisiana 70810, United States; Recruiting

Research Site, Foxboro, Massachusetts O2035, United States; Recruiting

Research Site, El Palmar, Murcia 30120, Spain; Recruiting

Research Site, Malaga, Málaga 29010, Spain; Recruiting

Research Site, Albuquerque, New Mexico 87131-0001, United States; Not yet recruiting

Research Site, Camperdown, New South Wales 2050, Australia; Not yet recruiting

Research Site, New Lambton Heights, New South Wales 2305, Australia; Recruiting

Research Site, Hannover, Niedersachsen 30625, Germany; Not yet recruiting

Research Site, Duesseldorf, Nordrhein Westfalen 40225, Germany; Not yet recruiting

Research Site, Siegen, Nordrhein Westfalen 57076, Germany; Not yet recruiting

Research Site, Mooresville, North Carolina 28117, United States; Recruiting

Research Site, Nottingham, Nottinghamshire NH7 2UH, United Kingdom; Recruiting

Research Site, Cefalù, Palermo 90015, Italy; Recruiting

Research Site, Philadelphia, Pennsylvania 19104, United States; Recruiting

Research Site, Vigo, Pontevedra 36204, Spain; Recruiting

Research Site, Providence, Rhode Island O2905, United States; Recruiting

Research Site, Gianicolense, Roma 87-00151, Italy; Recruiting

Research Site, Wermsdorf, Sachsen 04779, Germany; Recruiting

Research Site, Amiens Cedex 1, Somme 80054, France; Recruiting

Research Site, Glasgow, Strathclyde G51 4TF, United Kingdom; Recruiting

Research Site, Santa Cruz de Tenerife, Tenerife 38010, Spain; Not yet recruiting

Research Site, Knoxville, Tennessee 37922, United States; Recruiting

Research Site, Houston, Texas 77030, United States; Not yet recruiting

Research Site, Round Rock, Texas 78681, United States; Recruiting

Research Site, San Antonio, Texas 78229, United States; Recruiting

Research Site, Orbassano, Torino 10043, Italy; Not yet recruiting

Research Site, Gallarate, Varese 21013, Italy; Not yet recruiting

Research Site, Box Hill, Victoria 3128, Australia; Recruiting

Research Site, Heidelberg, Victoria 3084, Australia; Recruiting

Research Site, Melbourne, Victoria 3050, Australia; Recruiting

Research Site, Seattle, Washington 98122, United States; Recruiting

Research Site, Tacoma, Washington 98405, United States; Recruiting

Research Site, Milwaukee, Wisconsin 53215, United States; Recruiting

Additional Information

Starting date: November 2014
Last updated: July 23, 2015

Page last updated: August 23, 2015

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