G35 Multiple Sclerosis Multiple Sclerosis
Conditions
Interventions
None listed
Sponsors
F. HOFFMANN-LA ROCHE LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: • Signed ICF • Ages 18?55 years at time of signing ICF • Ability to comply with the study protocol • Diagnosis of RMS in accordance with the revised McDonald Criteria 2017 (Thompson et al. 2018) • At least two documented clinical attacks within the last 2 years prior to screening, or one clinical attack in the year prior to screening (with no relapse 30 days prior to screening and at baseline) • Patients must be neurologically stable for at least 30 days prior to randomization and baseline assessments • EDSS, at screening and baseline, from 0 to 5.5 inclusive • Documented MRI of brain with abnormalities consistent with MS prior to screening • Patients requiring symptomatic treatment for MS (e.g., fampridine, cannabis) and/or physiotherapy must be treated at a stable dose during the screening period prior to the initiation of study drug on Day 1 and must have a plan to remain at a stable dose for the duration of study treatment Patients must not initiate symptomatic treatment for MS or physiotherapy within 4 weeks of randomization. For more details, review the protocol.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: •History of primary progressive MS at screening • Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV anti microbials within 8 weeks prior to and during screening or treatment with oral anti microbials within 2 weeks prior to and during screening • History of confirmed or suspected progressive multifocal leukoencephalopathy (PML) • History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy >1year prior to screening is not exclusionary. For more details, review the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy objective will be assessed by risk reduction in cCDP sustained for at least 12 weeks. Time to onset of cCDP is defined as the first occurrence of a confirmed progression event according to at least one of the following three criteria: • CDP, defined as a sustained increase from baseline in EDSS score of =1.0 point in patients with a baseline EDSS score of =5.5 or a sustained increase =0.5 points in patients with a baseline EDSS score of =5.5, or • A sustained increase of =20% from baseline in T25FWT score, or • A sustained increase of =20% from baseline in time to complete the 9-HPT score. NAME OF THE RESULT: composite confirmed disability progression (cCDP) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout the study. The primary efficacy analysis will be performed after at least 205 events of cCDP12 have occurred in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The primary efficacy objective will be assessed by risk reduction in cCDP sustained for at least 12 weeks. Time to onset of cCDP is defined as the first occurrence of a confirmed progression event according to at least one of the following three criteria: • CDP, defined as a sustained increase from baseline in EDSS score of =1.0 point in patients with a baseline EDSS score of =5.5 or a sustained increase =0.5 points in patients with a baseline EDSS score of =5.5, or • A sustained increase of =20% from baseline in T25FWT score, or • A sustained increase of =20% from baseline in time to complete the 9-HPT score. NAME OF THE RESULT: composite confirmed disability progression (cCDP) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout the study. The primary efficacy analysis will be performed after at least 205 events of cCDP12 have occurred in the study.;Time to onset of 24-week cCDP (cCDP24). Composite CDP include time to progression measured by the expanded disability status scale (EDSS), Timed 25-Foot Walk (T25FWT) or 9- Hole Peg Test (9-HPT). NAME OF THE RESULT: 24-week composite confirmed disability progression (cCDP24) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout the study.;The time to onset of 12-week CDP (CDP12) is measure assesing an increase in a patient’s EDSS score. For more detail, review the protocol. NAME OF THE RESULT: Time to onset of 12-week CDP (CDP12) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout the estudy. For more details, review the protocol | — |
Countries
Belgium, Canada, Croatia, Finland, Hungary, Israel, Italy, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Serbia, Spain, United Kindgdom, United States
Outcome results
None listed