Secondary Progressive Multiple SclerosisPhase 3ASCEND in SPMSNCT01416181
A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis
A Phase 3 study testing natalizumab in people with Secondary Progressive Multiple Sclerosis, run by Biogen at 161 sites in 17 countries.
Trial summary
This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of the placebo-controlled period (Part 1), participants will have the option of enrolling in a 2-year open-label extension (Part 2). Read more about this study
- Who is it for?
- Ages 18 to 58 years
- Conditions the study is for
- Secondary Progressive Multiple Sclerosis
- What is being tested?
- natalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 889 participants
- Where
- 161 sitesin 17 countries
- Study dates
- 13 Sep 2011to 13 Apr 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
- SPMS defined as relapsing-remitting disease followed by progression of disability independent of or not explained by multiple sclerosis (MS) relapses for at least 2 years.
- EDSS score of 3.0 to 6.5, inclusive.
- Multiple Sclerosis Severity Score of 4 or higher.
- Documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to enrollment as defined in the Study Reference Guide.
- Subjects must have participated in and completed Part 1 per protocol, and have documented assessment attempts for EDSS, T25FW, and 9HPT prior to first open-label dosing.
Who cannot join
- Relapsing remitting multiple sclerosis (RRMS) or primary progressive MS as defined by the revised McDonald Committee criteria.
- Clinical relapse (within 3 months) prior to randomization.
- T25FW test of >30 seconds during the screening period.
- Any value below the lower limit of normal for blood levels of leukocytes, lymphocytes, or neutrophils.
- Considered by the Investigator to be immunocompromised based on medical history, physical examination, laboratory testing, or any other testing required by local guidelines, or due to prior immunosuppressive or immunomodulating treatment.
- Subjects for whom MRI is contraindicated (i.e., have pacemakers or other contraindicated implanted metal devices, are allergic to gadolinium, or have claustrophobia that cannot be medically managed).
Show all 23Show fewer
- History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, and renal, or other major disease that would preclude participation in a clinical study.
- History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
- Known history of or positive test result for human immunodeficiency virus.
- Positive test result for hepatitis C virus (test for hepatitis C virus antibody or hepatitis B virus (test for hepatitis B surface antigen and/or hepatitis B core antibody).
- History of transplantation or any anti-rejection therapy.
- Presence of any infectious disease (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to screening.
- History of progressive multifocal leukoencephalopathy or other opportunistic infections.
- Treatment History (Part 1)
- Any prior treatment with cell-depleting therapies, including total lymphoid irradiation, cladribine, rituximab, alemtuzumab, or bone marrow ablation.
- Any prior treatment with natalizumab.
- Treatment with mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, T cell or T cell receptor vaccination, fingolimod, daclizumab, or cytapheresis within 6 months prior to randomization.
- Treatment with intravenous or oral corticosteroids, intravenous immunoglobulin, or plasmapheresis for treatment of MS within the 3 months prior to randomization.
- Treatment with glatiramer acetate or any interferon beta preparations within 4 weeks prior to randomization.
- Treatment with 4-aminopyridine within 30 days prior to randomization, unless a stable dose has been maintained for at least 30 days prior to randomization and will be continued for the course of this study.
- Subjects with any significant change in clinical status, including laboratory tests that, in the opinion of the Investigator, would make them unsuitable to participate in this extension study. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment.
- Subjects who discontinued study treatment in Part 1 OR had fewer than 20 infusions in Part 1 OR missed 2 or more consecutive infusions in Part 1.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
161 sites in 17 countries.
161 sites in 17 countries
United States35 sites
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Advance, North Carolina, 27006
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Akron, Ohio, 44320
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Aurora, Colorado, 80045
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Baltimore, Maryland, 21287
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Burlington, Massachusetts, 01805
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Charlotte, North Carolina, 28207
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Charlottesville, Virginia, 22903
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Chicago, Illinois, 60637
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Clackamas, Oregon, 97015
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Fullerton, California, 92835
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Green Bay, Wisconsin, 54311
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Indianapolis, Indiana, 46202
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Indianapolis, Indiana, 46256
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Kansas City, Kansas, 66160
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Lake Barrington, Illinois, 60010
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Latham, New York, 12110
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Lebanon, New Hampshire, 03756
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Lexington, Kentucky, 40513
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Lexington, Kentucky, 40536
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Los Angeles, California, 90027
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Milwaukee, Wisconsin, 53215
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Nashville, Tennessee, 37215
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New York, New York, 10029
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Oklahoma City, Oklahoma, 73104
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Omaha, Nebraska, 68198
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Peoria, Illinois, 61606
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Phoenix, Arizona, 85013
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Portland, Oregon, 97225
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Portland, Oregon, 97239
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Raleigh, North Carolina, 27607
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Seattle, Washington, 98101
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Tampa, Florida, 33612
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Teaneck, New Jersey, 07666
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Tucson, Arizona, 85741
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Uniontown, Ohio, 44685
Poland17 sites
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Bialystok, 15-276
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Gdansk, 80-803
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Katowice, 40-595
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Katowice, 40-635
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Katowice, 40-749
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Krakow, 31-505
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Lodz, 90-324
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Lublin, 20-954
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Olsztyn, 10-561
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Plewiska, 62-064
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Poznan, 61-853
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Szczecin, 70-111
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Warsaw, 01-697
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Warsaw, 02-097
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Warsaw, 04-141
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Warszawa-Miedzylesie, 04-749
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Wroclaw, 50-556
United Kingdom17 sites
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Brighton, BN2 5BE
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Edgbaston, Birmingham, B15 2TH
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Edinburgh, Lothian Region, EH4 2XU
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Exeter, Devon, EX2 5DW
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Hammersmith, London, W6 8RF
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Irvine, Ayrshire, KA12 8SS
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Liverpool, Merseyside, L9 7LJ
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London, Greater London, E1 2AT
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London, Greater London, SE5 9RS
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London, WC1N 3BG
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Morriston, Swansea, SA6 6NL
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Newcastle, Tyne, NE1 4LP
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Norwich, Norfolk, NR4 7UY
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Nottingham, Nottinghamshire, NG7 2UH
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Plymouth, Devon, PL6 8BX
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Salford, Manchester, M6 8HD
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Sheffield, S10 2JF
Italy14 sites
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Baggiovara, Modena, 41100
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Bari, 70124
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Cefalù, Palermo, 90015
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Florence, 50134
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Gallarate, Varese, 21013
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Genova, 16132
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Milan, 20122
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Milan, 20132
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Naples, 80131
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Naples, 80138
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Palermo, 90146
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Pavia, 27100
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Rome, 00176
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Rome, 00189
Canada12 sites
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Calgary, Alberta, T2N 2T9
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Edmonton, Alberta, T6G 2G3
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Gatineau, Quebec, J9J 0A5
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Greenfield Park, Quebec, J4V 2J2
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Halifax, Nova Scotia, B3H 4K4
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Kingston, Ontario, K7L 2V7
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London, Ontario, N6A 5A5
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Montreal, Quebec, H2L 4M1
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Montreal, Quebec, H3A 2B4
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Ottawa, Ontario, K1H 8L6
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Toronto, Ontario, M4N 3M5
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Vancouver, British Columbia, V6T 1Z3
Germany11 sites
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Bad Mergentheim, Baden-Wurttemberg, 97980
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Bad Wilbad, Baden-Wurttemberg, 75323
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Dresden, Saxony, 01307
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Düsseldorf, North Rhine-Westphalia, 40225
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Hennigsdorf, Brandenburg, 16761
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Kassel, Hesse, 34121
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Munich, Bavaria, 81377
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Munich, Bavaria, 81675
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Münster, North Rhine-Westphalia, 48149
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Teupitz, Brandenburg, 15755
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Tübingen, Baden-Wurttemberg, 72076
Spain10 sites
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Barcelona, 08035
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Barcelona, 08036
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Barcelona, 08041
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El Palmar, 30120
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Madrid, 28034
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Madrid, 28040
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Majadahonda, 28222
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Málaga, 29010
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Santa Cruz de Tenerife, 38010
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Seville, 41009
France8 sites
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Bordeaux, 33076
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Bron, Rhone, 69677
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Lille, Nord, 59000
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Marseille, Bouches-du-Rhône, 13385
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Nancy, Meurthe et Moselle, 54035
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Nantes, Loire Atlantique, 44093
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Nice, Alpes Maritimes, 06002
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Salouël, Somme, 80054
Netherlands6 sites
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's-Hertogenbosch, 5223 GZ
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Amsterdam, 1081 HV
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Breda, 4800 RK
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Hoorn, 1624 NP
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Nieuwegein, 3430 EM
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Sittard-Geleen, 6130 MB
Russia6 sites
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Belgorod, 308007
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Kazan', 420021
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Kazan', 420097
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Moscow, 127015
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Saint Petersburg, 197110
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Tyumen, 625000
Sweden6 sites
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Gothenburg, 41345
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Örebro, 70185
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Stockholm, 14186
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Stockholm, 17176
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Stockholm, 18288
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Umeå, 90185
Denmark5 sites
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Arthus C, 8000
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Esbjerg, 6700
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Glostrup Municipality, 2600
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København Ø, 2100
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Odense, 5000
Czechia4 sites
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Brno, 65691
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Hradec Králové, Bohemia, 50005
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Olomouc, 77520
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Prague, 12111
Belgium3 sites
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La Louvière, 7100
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Melsbroek, 1820
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Overpelt, 3900
Finland3 sites
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Jyväskylä, 40620
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Tampere, 33520
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Turku, 20520
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension
This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of the placebo-controlled period (Part 1), participants will have the option of enrolling in a 2-year open-label extension (Part 2).
Part 1: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS).
Read more
The secondary objectives of Part 1 of this study are to determine the proportion of participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores.
Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of natalizumab in participants with SPMS.
The secondary objectives of Part 2 of the study are to investigate long-term disability (based on clinical or participant-reported assessments) in participants with SPMS receiving natalizumab treatment for approximately 4 years and to assess change in brain volume and T2 lesion volume.
- Conditions
- Secondary Progressive Multiple Sclerosis
- Being tested
- natalizumab, Placebo
- Keywords
- Natalizumab, secondary, multiple sclerosis, MS, SPMS, Tysabri
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Neoplasm Metastasis, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natalizumabDrug
Also called Tysabri, BG00002
Administered as specified in the treatment arm
PlaceboDrug
Matched placebo in part 1
| Study group | Role | What they receive |
|---|---|---|
| natalizumab | Experimental | In Part 1 participants were randomized to receive 300 mg of natalizumab intravenously (IV) every 4 weeks for 96 weeks. In Part 2 participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks. Receives: Drug: natalizumab |
| Placebo | Experimental | In Part 1 participants were randomized to receive placebo IV every 4 weeks for 96 weeks. In Part 2 participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks. Receives: Drug: natalizumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT)
Confirmed disability progression, defined as ≥1 of the following criteria (confirmed at a second visit ≥6 months later and at Week 96):
- Confirmed progression in EDSS (EDSS score increased from baseline [BL] by ≥1 point if BL EDSS ≤5.5 or by ≥0.5 points if BL EDSS ≥6);
- Confirmed progression in T25FW (T25FW increased by ≥20% of the BL walk);
- Confirmed progression in 9HPT (9HPT increased by ≥20% of the time taken at BL on either hand and confirmed on the same hand).
The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. The 95% confidence interval (CI) of the percentage is based on normal approximation.
Measured: Up to 96 weeks (2 years)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE may have also been any other medically important event in the opinion of the Investigator.
Measured: 218 weeks
Secondary outcomes (27)
Part 1: Percentage of Participants With a T25FW Response
T25FW response is defined as any improvement from the best pre-dose T25FW in at least 75% of the scheduled on-treatment visits through Week 96. The T25FW is a quantitative mobility and leg function performance test based on a timed walk over 25 feet. The participant is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. The score for the T25FW is the average of the 2 completed trials. The 95% CI of the percentage is based on normal approximation.
Measured: Up to 96 weeks
Part 1: Change From Baseline in the 12-Item MS Walking Scale (MSWS-12)
MSWS-12 is a participant self-assessment of the walking limitations due to MS during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where higher scores indicate greater impact on walking. A negative number on change from BL value indicates an improvement in MSWS-12.
Measured: Baseline and Week 96
Part 1: Change From Baseline in Manual Ability Score Based on the ABILHAND Questionnaire
The ABILHAND Questionnaire measures the participant's perceived difficulty in performing everyday manual activities in the last 3 months. The participant completes a 56-item questionnaire by estimating their own difficulty or ease in performing each of 56 activities. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where high scores indicate greater impact on manual ability. A positive number on change from baseline value indicates an improvement in ABILHAND.
Measured: Baseline and Week 96
Part 1: Change From Baseline in the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical) Score
The 29-item MSIS-29 is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participant's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health. A negative number on change from baseline value indicates an improvement in MSIS-29.
Measured: Baseline and Week 96
Part 1: Percentage Change From Week 24 in Whole Brain Volume at Week 96
Whole brain volume as measured by MRI.
Measured: Week 24 and Week 96
Part 1: Percentage of Participants Defined as Confirmed Progressors on EDSS Functional System Scores
The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Participants with confirmed progression of disability in EDSS physical functional system scores will be defined as those who met one of the following criteria:
- an increase of ≥ 1 point from baseline system score of ≥ 1 or an increase of ≥ 2 points from baseline system score of 0 in at least 2 physical functional systems, or
- an increase of ≥ 2 points from baseline system score of ≥ 1 or an increase of ≥ 3 points from baseline system score of 0 in any 1 physical functional system.
A confirmed progressor was defined as a participant who met the criteria for disability progression at any given visit and at the 6-Month Confirmation Visit. The 95% CIs are based on normal approximation.
Measured: Up to 96 weeks
Part 2: Percentage of Participants With Disability Worsening at 156 Weeks
Percentage of participants with disability worsening at each scheduled efficacy visit in Part 2, defined as one or more of the following: • ≥ 20% worsening from Part 1 baseline in T25FW; • ≥ 20% worsening from Part 1 baseline in 9HPT; • Worsening from Part 1 baseline in EDSS (≥ 1 point increase if Part 1 baseline EDSS ≤ 5.5 or ≥ 0.5 point increase if Part 1 baseline EDSS > 5.5). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. 95% CIs of percentages are based on normal approximation.
Measured: Week 156
Part 2: Absolute Change From Baseline (Part 1) in T25FW
The T25FW is a quantitative mobility and leg function performance test based on a timed 25-foot walk. The participant is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task is immediately repeated; the score for the T25FW is the average of the two completed trials. Lower scores on time taken to reach 25 foot mark reflect a better outcome. Values are presented for the overall group, as well as the Confirmed Progressor (CP, defined in the primary outcome measure description above) and Non-Progressor (NP) subgroups.
Measured: Baseline (Part 1) and Weeks 156, 204
Part 2: Percentage Change From Baseline (Part 1) in T25FW
The T25FW is a quantitative mobility and leg function performance test based on a timed 25-foot walk. The participant is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task is immediately repeated; the score for the T25FW is the average of the two completed trials. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.
Measured: Baseline (Part 1) and Weeks 156, 204
Part 2: Absolute Change From Baseline (Part 1) in 9HPT (Dominant Hand)
The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.
Measured: Baseline (Part 1) and Weeks 156, 204
Part 2: Percentage Change From Baseline (Part 1) in 9HPT (Dominant Hand)
The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.
Measured: Baseline (Part 1) and Weeks 156, 204
Part 2: Absolute Change From Baseline (Part 1) in 9HPT (Non-Dominant Hand)
The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.
Measured: Baseline (Part 1) and Weeks 156, 204
Part 2: Percentage Change From Baseline (Part 1) in 9HPT (Non-Dominant Hand)
The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.
Measured: Baseline (Part 1) and Weeks 156, 204
Part 2: Absolute Change From Baseline (Part 1) in EDSS
The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.
Measured: Baseline (Part 1) and Weeks 156, 204
Part 2: Percentage Change From Baseline (Part 1) in EDSS
The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.
Measured: Baseline (Part 1) and Weeks 156, 204
Part 2: Absolute Change From Baseline (Part 1) in the 6-Minute Walk Test (6MWT)
The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Measured: Baseline (Part 1) and Weeks 156 and 204
Part 2: Percentage Change From Baseline (Part 1) in the 6MWT
The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Measured: Baseline (Part 1) and Weeks 156, 204
Part 2: Absolute Change From Baseline (Part 1) in the MSIS-29 Physical Score
The 29-item MSIS-29 is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health. A negative number on change from baseline value indicates an improvement in MSIS-29.
Measured: Baseline (Part 1) and Weeks 156 and 204
Part 2: Percentage Change From Baseline (Part 1) in the MSIS-29 Physical Score
The 29-item MSIS-29 is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health. A negative number on change from baseline value indicates an improvement in MSIS-29.
Measured: Baseline (Part 1) and Weeks 156, 204
Part 2: Absolute Change From Baseline (Part 1) in the Symbol Digit Modalities Test (SDMT)
SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best).
Measured: Baseline (Part 1) and every 4 weeks from Week 108 to Week 204
Part 2: Percentage Change From Baseline (Part 1) in the SDMT
SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best).
Measured: Baseline (Part 1) and every 4 weeks from Week 108 to Week 204
Part 2: Absolute Change From Baseline (Part 2) in the Work Productivity and Activity Impairment - Multiple Sclerosis (WPAI-MS) Questionnaire
The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (percentage of work time missed) 2. Presenteesism (percentage of impairment at work/reduced on-the-job effectiveness) 3. Work productivity loss (percentage of overall work impairment [absenteeism plus presenteeism]) 4. Activity Impairment (percentage of overall activity impairment). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Measured: Part 2 Baseline (Week 108) and Weeks 156 and 204
Part 2: Percentage Change From Baseline (Part 2) in the WPAI-MS Questionnaire
The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (percentage of work time missed) 2. Presenteesism (percentage of impairment at work/reduced on-the-job effectiveness) 3. Work productivity loss (WPL; percentage of overall work impairment [absenteeism plus presenteeism]) 4. Activity Impairment (AI; percentage of overall activity impairment). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Measured: Part 2 Baseline (Week 108) and Weeks 156 and 204
Part 2: Percentage Change From Week 24 (Part 1) in Whole Brain Volume
Whole brain volume as measured by MRI.
Measured: Week 24 (Part 1) and Weeks 156 and 204
Part 2: Percentage Change From Baseline (Part 1) in Whole Gray Matter Brain Volume
Whole grey matter brain volume as measured by MRI.
Measured: Baseline (Part 1) and Weeks 156 and 204
Part 2: Summary of New/Enlarging T2 Lesion Counts
New or enlarging T2 lesions as measured by MRI.
Measured: Baseline (Part 1) up to Week 204
Part 2: Percentage Change From Baseline (Part 1) in Number of New/Enlarging T2 Lesions
New or enlarging T2 lesions as measured by MRI.
Measured: Baseline (Part 1) and Weeks 156 and 204
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study start13 Sep 2011
- Primary completion28 Jul 2015
- Study completion13 Apr 2016
Why it stopped: The ASCEND Study did not achieve statistical significance on the primary or secondary endpoints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Secondary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 889 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416181
- Sponsor's protocol ID
- 101MS326
- Other IDs
- 2010-021978-11
- Acronym
- ASCEND in SPMS
- Status last verified
- Aug 2017
- First submitted
- 21 Jul 2011
- Last updated
- 11 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Loomis SJ, Sadhu N, Fisher E, Gafson AR, Huang Y, Yang C, Hughes EE, Marshall E, Herman A, John S, Runz H, Jia X, Bhangale T, Bronson PG. Genome-wide study of longitudinal brain imaging measures of multiple sclerosis progression across six clinical trials. Sci Rep. 2023 Aug 31;13(1):14313. doi: 10.1038/s41598-023-41099-0.
PubMed 37652990Beynon V, George IC, Elliott C, Arnold DL, Ke J, Chen H, Zhu L, Ke C, Giovannoni G, Scaramozza M, Campbell N, Bradley DP, Franchimont N, Gafson A, Belachew S. Chronic lesion activity and disability progression in secondary progressive multiple sclerosis. BMJ Neurol Open. 2022 Jun 7;4(1):e000240. doi: 10.1136/bmjno-2021-000240. eCollection 2022.
PubMed 35720980Koch MW, Mostert J, Zhang Y, Wolinsky JS, Lublin FD, Strijbis E, Cutter G. Association of Age With Contrast-Enhancing Lesions Across the Multiple Sclerosis Disease Spectrum. Neurology. 2021 Sep 28;97(13):e1334-e1342. doi: 10.1212/WNL.0000000000012603. Epub 2021 Aug 10.
PubMed 34376508Kapoor R, Ho PR, Campbell N, Chang I, Deykin A, Forrestal F, Lucas N, Yu B, Arnold DL, Freedman MS, Goldman MD, Hartung HP, Havrdova EK, Jeffery D, Miller A, Sellebjerg F, Cadavid D, Mikol D, Steiner D; ASCEND investigators. Effect of natalizumab on disease progression in secondary progressive multiple sclerosis (ASCEND): a phase 3, randomised, double-blind, placebo-controlled trial with an open-label extension. Lancet Neurol. 2018 May;17(5):405-415. doi: 10.1016/S1474-4422(18)30069-3. Epub 2018 Mar 12.
PubMed 29545067
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension
- ClinicalTrials.gov ID
- NCT01416181
- Acronym / sponsor ID
- ASCEND in SPMS / 101MS326
- Conditions
- Secondary Progressive Multiple Sclerosis
- Keywords
- Natalizumab, secondary, multiple sclerosis, MS, SPMS, Tysabri
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The ASCEND Study did not achieve statistical significance on the primary or secondary endpoints.
- Enrolment
- 889 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2011 (actual)
- Primary completion
- 28 Jul 2015 (actual)
- Study completion
- 13 Apr 2016 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Posted 27 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of the placebo-controlled period (Part 1), participants will have the option of enrolling in a 2-year open-label extension (Part 2).
Part 1: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS).
The secondary objectives of Part 1 of this study are to determine the proportion of participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores.
Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of natalizumab in participants with SPMS.
The secondary objectives of Part 2 of the study are to investigate long-term disability (based on clinical or participant-reported assessments) in participants with SPMS receiving natalizumab treatment for approximately 4 years and to assess change in brain volume and T2 lesion volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| natalizumab | Experimental | Drug: natalizumabIn Part 1 participants were randomized to receive 300 mg of natalizumab intravenously (IV) every 4 weeks for 96 weeks. In Part 2 participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks. |
| Placebo | Experimental | Drug: natalizumab, Drug: PlaceboIn Part 1 participants were randomized to receive placebo IV every 4 weeks for 96 weeks. In Part 2 participants transitioned to receive open-label natalizumab 300 mg IV every 4 weeks for at least 96 weeks. |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
- SPMS defined as relapsing-remitting disease followed by progression of disability independent of or not explained by multiple sclerosis (MS) relapses for at least 2 years.
- EDSS score of 3.0 to 6.5, inclusive.
- Multiple Sclerosis Severity Score of 4 or higher.
- Documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to enrollment as defined in the Study Reference Guide.
Key exclusion criteria (23 listed)
- Relapsing remitting multiple sclerosis (RRMS) or primary progressive MS as defined by the revised McDonald Committee criteria.
- Clinical relapse (within 3 months) prior to randomization.
- T25FW test of >30 seconds during the screening period.
- Any value below the lower limit of normal for blood levels of leukocytes, lymphocytes, or neutrophils.
- Considered by the Investigator to be immunocompromised based on medical history, physical examination, laboratory testing, or any other testing required by local guidelines, or due to prior immunosuppressive or immunomodulating treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| natalizumabAlso: Tysabri, BG00002Administered as specified in the treatment arm | Drug | Placebo, natalizumab |
| PlaceboMatched placebo in part 1 | Drug | Placebo |
Primary outcome
Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT)
Time frame: Up to 96 weeks (2 years)
Confirmed disability progression, defined as ≥1 of the following criteria (confirmed at a second visit ≥6 months later and at Week 96): * Confirmed progression in EDSS (EDSS score increased from baseline [BL] by ≥1 point if BL EDSS ≤5.5 or by ≥0.5 points if BL EDSS ≥6); * Confirmed progression in T25FW (T25FW increased by ≥20% of the BL walk); * Confirmed progression in 9HPT (9HPT increased by ≥20% of the time taken at BL on either hand and confirmed on the same hand). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. The 95% confidence interval (CI) of the percentage is based on normal approximation.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 218 weeks
AE: any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE may have also been any other medically important event in the opinion of the Investigator.
27 secondary outcomes
Part 1: Percentage of Participants With a T25FW Response
Time frame: Up to 96 weeks
Part 1: Change From Baseline in the 12-Item MS Walking Scale (MSWS-12)
Time frame: Baseline and Week 96
Part 1: Change From Baseline in Manual Ability Score Based on the ABILHAND Questionnaire
Time frame: Baseline and Week 96
Part 1: Change From Baseline in the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical) Score
Time frame: Baseline and Week 96
Part 1: Percentage Change From Week 24 in Whole Brain Volume at Week 96
Time frame: Week 24 and Week 96
Part 1: Percentage of Participants Defined as Confirmed Progressors on EDSS Functional System Scores
Time frame: Up to 96 weeks
Part 2: Percentage of Participants With Disability Worsening at 156 Weeks
Time frame: Week 156
Part 2: Absolute Change From Baseline (Part 1) in T25FW
Time frame: Baseline (Part 1) and Weeks 156, 204
Part 2: Percentage Change From Baseline (Part 1) in T25FW
Time frame: Baseline (Part 1) and Weeks 156, 204
Part 2: Absolute Change From Baseline (Part 1) in 9HPT (Dominant Hand)
Time frame: Baseline (Part 1) and Weeks 156, 204
Part 2: Percentage Change From Baseline (Part 1) in 9HPT (Dominant Hand)
Time frame: Baseline (Part 1) and Weeks 156, 204
Part 2: Absolute Change From Baseline (Part 1) in 9HPT (Non-Dominant Hand)
Time frame: Baseline (Part 1) and Weeks 156, 204
Part 2: Percentage Change From Baseline (Part 1) in 9HPT (Non-Dominant Hand)
Time frame: Baseline (Part 1) and Weeks 156, 204
Part 2: Absolute Change From Baseline (Part 1) in EDSS
Time frame: Baseline (Part 1) and Weeks 156, 204
Part 2: Percentage Change From Baseline (Part 1) in EDSS
Time frame: Baseline (Part 1) and Weeks 156, 204
Part 2: Absolute Change From Baseline (Part 1) in the 6-Minute Walk Test (6MWT)
Time frame: Baseline (Part 1) and Weeks 156 and 204
Part 2: Percentage Change From Baseline (Part 1) in the 6MWT
Time frame: Baseline (Part 1) and Weeks 156, 204
Part 2: Absolute Change From Baseline (Part 1) in the MSIS-29 Physical Score
Time frame: Baseline (Part 1) and Weeks 156 and 204
Part 2: Percentage Change From Baseline (Part 1) in the MSIS-29 Physical Score
Time frame: Baseline (Part 1) and Weeks 156, 204
Part 2: Absolute Change From Baseline (Part 1) in the Symbol Digit Modalities Test (SDMT)
Time frame: Baseline (Part 1) and every 4 weeks from Week 108 to Week 204
Part 2: Percentage Change From Baseline (Part 1) in the SDMT
Time frame: Baseline (Part 1) and every 4 weeks from Week 108 to Week 204
Part 2: Absolute Change From Baseline (Part 2) in the Work Productivity and Activity Impairment - Multiple Sclerosis (WPAI-MS) Questionnaire
Time frame: Part 2 Baseline (Week 108) and Weeks 156 and 204
Part 2: Percentage Change From Baseline (Part 2) in the WPAI-MS Questionnaire
Time frame: Part 2 Baseline (Week 108) and Weeks 156 and 204
Part 2: Percentage Change From Week 24 (Part 1) in Whole Brain Volume
Time frame: Week 24 (Part 1) and Weeks 156 and 204
Part 2: Percentage Change From Baseline (Part 1) in Whole Gray Matter Brain Volume
Time frame: Baseline (Part 1) and Weeks 156 and 204
Part 2: Summary of New/Enlarging T2 Lesion Counts
Time frame: Baseline (Part 1) up to Week 204
Part 2: Percentage Change From Baseline (Part 1) in Number of New/Enlarging T2 Lesions
Time frame: Baseline (Part 1) and Weeks 156 and 204
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37652990Loomis SJ, Sadhu N, Fisher E, Gafson AR, Huang Y, Yang C, Hughes EE, Marshall E, Herman A, John S, Runz H, Jia X, Bhangale T, Bronson PG. Genome-wide study of longitudinal brain imaging measures of multiple sclerosis progression across six clinical trials. Sci Rep. 2023 Aug 31;13(1):14313. doi: 10.1038/s41598-023-41099-0.
- Derived from this study: PubMed 35720980Beynon V, George IC, Elliott C, Arnold DL, Ke J, Chen H, Zhu L, Ke C, Giovannoni G, Scaramozza M, Campbell N, Bradley DP, Franchimont N, Gafson A, Belachew S. Chronic lesion activity and disability progression in secondary progressive multiple sclerosis. BMJ Neurol Open. 2022 Jun 7;4(1):e000240. doi: 10.1136/bmjno-2021-000240. eCollection 2022.
- Derived from this study: PubMed 34376508Koch MW, Mostert J, Zhang Y, Wolinsky JS, Lublin FD, Strijbis E, Cutter G. Association of Age With Contrast-Enhancing Lesions Across the Multiple Sclerosis Disease Spectrum. Neurology. 2021 Sep 28;97(13):e1334-e1342. doi: 10.1212/WNL.0000000000012603. Epub 2021 Aug 10.
- Derived from this study: PubMed 29545067Kapoor R, Ho PR, Campbell N, Chang I, Deykin A, Forrestal F, Lucas N, Yu B, Arnold DL, Freedman MS, Goldman MD, Hartung HP, Havrdova EK, Jeffery D, Miller A, Sellebjerg F, Cadavid D, Mikol D, Steiner D; ASCEND investigators. Effect of natalizumab on disease progression in secondary progressive multiple sclerosis (ASCEND): a phase 3, randomised, double-blind, placebo-controlled trial with an open-label extension. Lancet Neurol. 2018 May;17(5):405-415. doi: 10.1016/S1474-4422(18)30069-3. Epub 2018 Mar 12.
- Find out what to expect with TYSABRI MS treatmentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
161 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing natalizumab in people with Secondary Progressive Multiple Sclerosis, run by Biogen at 161 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 161 sites in United States, Poland, United Kingdom, Italy, Canada and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT) (time frame: Up to 96 weeks (2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01416181, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.