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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02468674




Registration number
NCT02468674
Ethics application status
Date submitted
30/04/2015
Date registered
11/06/2015

Titles & IDs
Public title
A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study
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)
Secondary ID [1] 0 0
2015-000471-27
Secondary ID [2] 0 0
CBYM338E2202E1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49
Timepoint [1] 0 0
Week 49
Primary outcome [2] 0 0
Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49
Timepoint [2] 0 0
Week 49
Secondary outcome [1] 0 0
Population I: 6-minute Walking Distance (6MWT) at Week 49
Timepoint [1] 0 0
Week 49
Secondary outcome [2] 0 0
Population II: 6-minute Walking Distance (6MWT) at Week 49
Timepoint [2] 0 0
Week 49
Secondary outcome [3] 0 0
Population I: Gait Speed at Week 49
Timepoint [3] 0 0
Week 49
Secondary outcome [4] 0 0
Population II: Gait Speed at Week 49
Timepoint [4] 0 0
Week 49
Secondary outcome [5] 0 0
Population I: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
Timepoint [5] 0 0
Week 49
Secondary outcome [6] 0 0
Population II: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
Timepoint [6] 0 0
Week 49
Secondary outcome [7] 0 0
Population I: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
Timepoint [7] 0 0
Week 49
Secondary outcome [8] 0 0
Population II: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
Timepoint [8] 0 0
Week 49

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)
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criterion:

- Any condition which should have led to treatment discontinuation per protocol in the core study (CBYM338E2202)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/12/2018
Sample size
Target
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - St Albans
Recruitment postcode(s) [1] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
South Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Wisconsin
Country [6] 0 0
Belgium
State/province [6] 0 0
Brussel
Country [7] 0 0
Czechia
State/province [7] 0 0
Praha 2
Country [8] 0 0
Denmark
State/province [8] 0 0
Copenhagen NV
Country [9] 0 0
France
State/province [9] 0 0
Montpellier
Country [10] 0 0
France
State/province [10] 0 0
Pessac
Country [11] 0 0
Japan
State/province [11] 0 0
Aichi
Country [12] 0 0
Japan
State/province [12] 0 0
Gifu
Country [13] 0 0
Japan
State/province [13] 0 0
Nara
Country [14] 0 0
Japan
State/province [14] 0 0
Osaka
Country [15] 0 0
Japan
State/province [15] 0 0
Saitama
Country [16] 0 0
Japan
State/province [16] 0 0
Tokyo
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Gyeonggi Do
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Moscow
Country [19] 0 0
Russian Federation
State/province [19] 0 0
St Petersburg
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Yaroslavl
Country [21] 0 0
Spain
State/province [21] 0 0
Castilla La Mancha
Country [22] 0 0
Spain
State/province [22] 0 0
Madrid
Country [23] 0 0
Switzerland
State/province [23] 0 0
Genève 14
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02468674