Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis (ASCEND in SPMS)

This study has been terminated.
(The ASCEND Study did not achieve statistical significance on the primary or secondary endpoints.)
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01416181
First received: July 21, 2011
Last updated: July 15, 2016
Last verified: July 2016
  Purpose

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 patient-reported assessments) in participants with SPMS receiving natalizumab treatment for approximately 4 years and to assess change in brain volume and T2 lesion volume.


Condition Intervention Phase
Secondary Progressive Multiple Sclerosis
Drug: natalizumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Confirmed disability progression is defined as one or more of the following criteria, confirmed at a second visit at least 6 months later and at Week 96: • Confirmed progression in EDSS: EDSS score increased from baseline by at least 1 point if baseline EDSS ≤5.5 or by at least 0.5 points if baseline EDSS ≥6; • Confirmed progression in T25FW: T25FW increased by at least 20% of the baseline walk; • Confirmed progression in 9HPT: 9HPT increased by at least 20% of the time taken at baseline. The progression in 9HPT can occur on either hand, but will have to be 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 number of participants with Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: 218 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Part 1: Percentage of participants with a Timed 25-Foot Walk (T25FW) response [ Time Frame: Up to 96 weeks ] [ Designated as safety issue: No ]
    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 two completed trials.

  • Part 1: Change from Baseline in the 12-Item MS Walking Scale (MSWS-12) [ Time Frame: Baseline and Week 96 ] [ Designated as safety issue: No ]
    MSWS-12 is a patient 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.

  • Part 1: Change from Baseline in manual ability score based on the ABILHAND Questionnaire [ Time Frame: Baseline and Week 96 ] [ Designated as safety issue: No ]
    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.

  • Part 1: Change from Baseline in the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical) score [ Time Frame: Baseline and Week 96 ] [ Designated as safety issue: No ]
    The 29-item Multiple Sclerosis Impact Scale (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.

  • Part 1: Change from Week 24 in whole brain volume [ Time Frame: Week 24 and Week 96 ] [ Designated as safety issue: No ]
    Whole brain volume will be measured by magnetic resonance imaging

  • Part 1: Percentage of participants with confirmed worsening in individual Expanded Disability Status Scale (EDSS) Physical Functional System scores [ Time Frame: Up to 96 weeks ] [ Designated as safety issue: No ]
    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 meet 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. Worsening must be confirmed on a subsequent examination using the same criterion in the same functional system(s) at least 6 months later.

  • Part 2: Percentage of participants with disability worsening [ Time Frame: Up to week 204 ] [ Designated as safety issue: No ]
    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.

  • Part 2: Absolute change from Baseline (Part 1) in Timed 25-Foot Walk (T25FW) [ Time Frame: Baseline (Part 1) and Weeks 156, 204, and 252 ] [ Designated as safety issue: No ]
    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.

  • Part 2: Percentage change from Baseline (Part 2) in Timed 25-Foot Walk (T25FW) [ Time Frame: Baseline (Part 1) and Weeks 156, 204, and 252 ] [ Designated as safety issue: No ]
  • Part 2: Absolute change from Baseline (Part 1) in 9-Hole Peg Test (9HPT) [ Time Frame: Baseline (Part 1) and Weeks 156, 204, and 252 ] [ Designated as safety issue: No ]
    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.

  • Part 2: Percentage change from Baseline (Part 1) in 9-Hole Peg Test (9HPT) [ Time Frame: Baseline (Part 1) and Weeks 156, 204, and 252 ] [ Designated as safety issue: No ]
  • Part 2: Absolute change from Baseline (Part 1) in Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline (Part 1) and Weeks 156, 204, and 252 ] [ Designated as safety issue: No ]
    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.

  • Part 2: Percentage change from Baseline (Part 1) in Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline (Part 1) and Weeks 156, 204, and 252 ] [ Designated as safety issue: No ]
  • Part 2: Absolute change from Baseline (Part 1) in the 6-Minute Walk Test (6MWT) [ Time Frame: Baseline (Part 1) and Weeks 156, 204, and 252 ] [ Designated as safety issue: No ]
    The six-minute walk test (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.

  • Part 2: Percentage change from Baseline (Part 1) in the 6-Minute Walk Test (6MWT) [ Time Frame: Baseline (Part 1) and Weeks 156, 204, and 252 ] [ Designated as safety issue: No ]
  • Part 2: Absolute change from Baseline (Part 1) in the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical) [ Time Frame: Baseline (Part 1) and Weeks 156, 204, and 252 ] [ Designated as safety issue: No ]
    The 29-item Multiple Sclerosis Impact Scale (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.

  • Part 2: Percentage change from Baseline (Part 1) in the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical) [ Time Frame: Baseline (Part 1) and Weeks 156, 204, and 252 ] [ Designated as safety issue: No ]
  • 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 252 ] [ Designated as safety issue: No ]
    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).

  • Part 2: Percentage 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 252 ] [ Designated as safety issue: No ]
  • 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, 204 and 252 ] [ Designated as safety issue: No ]
    The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

  • Part 2: Percentage 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, 204 and 252 ] [ Designated as safety issue: No ]
  • Part 2: Percentage change from Baseline (Part 1) in whole brain volume [ Time Frame: Baseline (Part 1) and Weeks 156, 204, and 252 ] [ Designated as safety issue: No ]
    Brain volume will be measured by magnetic resonance imaging (MRI).

  • Part 2: Percentage change from Baseline (Part 1) in gray matter brain volume [ Time Frame: Baseline (Part 1) and Weeks 156, 204, and 252 ] [ Designated as safety issue: No ]
  • Part 2: Absolute change from Baseline (Part 1) in number of new/enlarging T2 lesions [ Time Frame: Baseline (Part 1) and Weeks 156, 204, and 252 ] [ Designated as safety issue: No ]
    Measured by magnetic resonance imaging (MRI).

  • Part 2: Percentage change from Baseline (Part 1) in number of new/enlarging T2 lesions [ Time Frame: Baseline (Part 1) and Weeks 156, 204, and 252 ] [ Designated as safety issue: No ]

Enrollment: 889
Study Start Date: September 2011
Study Completion Date: April 2016
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: natalizumab
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 and up to a maximum of 144 weeks.
Drug: natalizumab
Administered as specified in the treatment arm
Other Names:
  • Tysabri
  • BG00002
Experimental: Placebo
In Part 1 participants were randomized to receive placebo intravenously 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 and up to a maximum of 144 weeks.
Drug: natalizumab
Administered as specified in the treatment arm
Other Names:
  • Tysabri
  • BG00002
Drug: Placebo
Matched placebo in part 1

  Eligibility

Ages Eligible for Study:   18 Years to 58 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria (Part 1):

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
  • Secondary progressive multiple sclerosis (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.
  • Expanded Disability Status Scale (EDSS) score of 3.0 to 6.5, inclusive.
  • Multiple Sclerosis Severity Score (MSSS) 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 (Part 1):

  • Relapsing remitting multiple sclerosis (RRMS) or primary progressive multiple sclerosis (MS) as defined by the revised McDonald Committee criteria.
  • Clinical relapse (within 3 months) prior to randomization.
  • Timed 25-Foot Walk (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 magnetic resonance imaging (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).
  • 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 (HIV).
  • Positive test result for hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]).
  • 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 (PML) 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 (IVIg), or plasmapheresis for treatment of multiple sclerosis 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.

Key Inclusion Criteria (Part 2):

  • Subjects must have participated in and completed Part 1 per protocol, and have documented assessment attempts for Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), and 9-Hole Peg Test (9HPT) prior to first open-label dosing.

Key Exclusion Criteria (Part 2):

  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416181

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Liverpool, Merseyside, United Kingdom, L9 7LJ
Research Site
Norwich, Norfolk, United Kingdom, NR4 7UY
Research Site
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Research Site
Morriston, Swansea, United Kingdom, SA6 6NL
Research Site
Newcastle Upon Tyne, Tyne, United Kingdom, NE1 4LP
Research Site
Sheffield, West Midlands, United Kingdom, S10 2JF
Research Site
Brighton, West Sussex, United Kingdom, BN2 5BE
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Additional Information:
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01416181     History of Changes
Other Study ID Numbers: 101MS326  2010-021978-11 
Study First Received: July 21, 2011
Last Updated: July 15, 2016
Health Authority: Israel: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Ireland: Irish Medicines Board
Spain: Spanish Agency of Medicines
Czech Republic: State Institute for Drug Control
Sweden: Medical Products Agency
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration
Finland: Finnish Medicines Agency
Germany: Paul-Ehrlich-Institut
Russia: Ministry of Health of the Russian Federation
Italy: The Italian Medicines Agency

Keywords provided by Biogen:
Natalizumab
secondary
multiple sclerosis
MS
SPMS
Tysabri

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Neoplasm Metastasis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neoplastic Processes
Neoplasms
Natalizumab
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016