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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02468674
Registration number
NCT02468674
Ethics application status
Date submitted
30/04/2015
Date registered
11/06/2015
Date last updated
16/06/2020
Titles & IDs
Public title
A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study
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Scientific title
A 24 Week Off Drug Extension, Parallel Group, Study Assessing Durability of Effect on Skeletal Muscle Strength and Function Following a 6-month Double-blind, Placebo Controlled Study Evaluating Bimagrumab in Older Adults With Sarcopenia (InvestiGAIT Extension)
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Secondary ID [1]
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2015-000471-27
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Secondary ID [2]
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CBYM338E2202E1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sarcopenia
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - bimagrumab
Treatment: Drugs - Placebo
Other: Follow-up (arm 1) - Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
No Intervention: Follow-up (arm 2) - Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
Treatment: Drugs: bimagrumab
bimagrumab low dose bimagrumab moderate dose bimagrumab high dose
Patients enrolled prior to the protocol amendment 1 (Population I ), who received bimagrumab in the core study, entered the extension study at Week 25 and were randomly assigned to two subgroups within each of three treatment arms to either receive bimagrumab at the same dose level or placebo. Study medication was administered as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45.
Treatment: Drugs: Placebo
Placebo
Patients enrolled prior to the protocol amendment 1 (Population I), who received placebo in core study, entered the extension study at Week 25 and received placebo as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49
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Assessment method [1]
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SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
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Timepoint [1]
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Week 49
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Primary outcome [2]
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Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49
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Assessment method [2]
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SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
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Timepoint [2]
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Week 49
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Secondary outcome [1]
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Population I: 6-minute Walking Distance (6MWT) at Week 49
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Assessment method [1]
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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. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. A high 6MWT represent better physical condition.
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Timepoint [1]
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Week 49
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Secondary outcome [2]
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Population II: 6-minute Walking Distance (6MWT) at Week 49
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Assessment method [2]
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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. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. A high 6MWT represent better physical condition.
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Timepoint [2]
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Week 49
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Secondary outcome [3]
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Population I: Gait Speed at Week 49
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Assessment method [3]
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Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.
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Timepoint [3]
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Week 49
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Secondary outcome [4]
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Population II: Gait Speed at Week 49
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Assessment method [4]
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Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.
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Timepoint [4]
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Week 49
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Secondary outcome [5]
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Population I: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
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Assessment method [5]
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ASMI is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.
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Timepoint [5]
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Week 49
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Secondary outcome [6]
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Population II: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
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Assessment method [6]
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ASMI is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.
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Timepoint [6]
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Week 49
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Secondary outcome [7]
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Population I: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
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Assessment method [7]
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LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect
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Timepoint [7]
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Week 49
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Secondary outcome [8]
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Population II: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
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Assessment method [8]
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LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect
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Timepoint [8]
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Week 49
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Eligibility
Key inclusion criteria
Inclusion criterion:
- Men and postmenopausal women aged 70 years or older that have participated in, and have
completed the full study treatment period per protocol (24 weeks/EOT visit) in the
preceding core study (CBYM338E2202)
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Minimum age
70
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criterion:
- Any condition which should have led to treatment discontinuation per protocol in the core
study (CBYM338E2202)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/07/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/12/2018
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Sample size
Target
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Accrual to date
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Final
160
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - St Albans
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Recruitment postcode(s) [1]
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3021 - St Albans
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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United States of America
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State/province [2]
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Georgia
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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Wisconsin
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Belgium
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Brussel
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Czechia
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Praha 2
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Denmark
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Copenhagen NV
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France
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Montpellier
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France
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Pessac
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Japan
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Aichi
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Japan
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Gifu
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Japan
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Nara
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Korea, Republic of
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Gyeonggi Do
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Russian Federation
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Moscow
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Russian Federation
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St Petersburg
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Russian Federation
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Yaroslavl
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Spain
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Castilla La Mancha
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Spain
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Madrid
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Switzerland
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Genève 14
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This extension study was a 24-week off-drug follow-up of the core CBYM338E2202 (NCT ) study
and the main objective was to determine the long-term durability of bimagrumab (BYM338)
effect after a 6-month treatment period.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02468674
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02468674
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