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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/NCT02330965




Registration number
NCT02330965
Ethics application status
Date submitted
31/12/2014
Date registered
5/01/2015
Date last updated
9/11/2020

Titles & IDs
Public title
Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis
Scientific title
Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)
Secondary ID [1] 0 0
DAIT AMS04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Secondary Progressive Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Blood Draw
Treatment: Surgery - CSF collection by lumbar puncture (Optional)

Subjects Assigned to BAF312 - Patients with secondary progressive multiple sclerosis (SPMS) randomized to receive BAF312 (siponimod). Refer to ClinicalTrials.gov record NCT01665144 for more information.

Subjects Assigned to Placebo (Controls) - Patients with secondary progressive multiple sclerosis (SPMS) randomized to receive placebo. Refer to ClinicalTrials.gov record NCT01665144 for more information.


Treatment: Surgery: Blood Draw
Blood draws (65 mLs [~4 tablespoons] per blood draw) at 4 time points: Prior to study medication initiation, and at +6, +12 and+24 months post treatment initiation.

Treatment: Surgery: CSF collection by lumbar puncture (Optional)
For participants who volunteer to donate CSF samples: up to 25 mLs (<2 tablespoons): prior to study medication initiation, and at month 24 post treatment initiation.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in frequency of MBP-reactive Th17 cells
Timepoint [1] 0 0
From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
Secondary outcome [1] 0 0
Change in frequency of polyclonal CD4+ Th17, Th1, Th2, and Treg cells
Timepoint [1] 0 0
From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
Secondary outcome [2] 0 0
Change in chemokine and cytokines levels
Timepoint [2] 0 0
From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
Secondary outcome [3] 0 0
Change in Regulatory B Cells
Timepoint [3] 0 0
From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
Secondary outcome [4] 0 0
Changes of clinical status and lymphocyte subgroups
Timepoint [4] 0 0
From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).

Eligibility
Key inclusion criteria
- Participants enrolled in the multicenter, randomized, double-blind, parallel-group,
placebo-controlled, variable treatment duration study comparing the efficacy and
safety of BAF312 to placebo in patients with Secondary Progressive Multiple Sclerosis
(SPMS) Protocol No. CBAF312A2304 (sponsored by Novartis). Refer to ClinicalTrials.gov
record NCT01665144.

- Subjects enrolled at one of the participating AMS04 study sites located in the United
States.

- Subject must be able to provide written informed consent.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects with severe bleeding disorders, platelet count less than
(<)50,000/microliters (µL), and/or who are currently on full anticoagulant therapy
will be excluded from the optional CSF collections.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/07/2017
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New Mexico
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Autoimmunity Centers of Excellence
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Novartis Pharmaceuticals
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary goal of this study is to evaluate the effects of BAF312 (siponimod) on select
immune and neuronal (nerve) cells by examining laboratory specimens (blood and/or spinal
fluid) at multiple time points, prior to, and following the initiation of BAF312 or placebo
treatment, in patients with Secondary Progressive Multiple Sclerosis (SPMS) who are enrolled
in a clinical trial (NCT01665144) to evaluate the effectiveness and safety of BAF312.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02330965
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Yang Mao-Draayer, MD, PhD
Address 0 0
Multiple Sclerosis Center - University of Michigan Health System
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