Individualizing Treatment Decisions for Adult Relapsing-Remitting Multiple Sclerosis Patients Using Statistical Learning Methods

Individualizing Treatment Decisions for Adult Relapsing-Remitting Multiple Sclerosis Patients Using Statistical Learning Methods

Multiple Sclerosis (MS) is an incurable disease of the nervous system. Many disease-modifying treatment options have been developed for MS. Individual response to these therapies varies significantly across people with MS. Specific treatments may be effective in some patients while harmful in others. Due to heterogeneous disease courses and benefit-harm balance, it is not clear which treatments provide the greatest net benefit. This question is of relevance both before starting treatment and after initiation. Also, observed disability worsening in MS usually occurs over a long period. Hence, short-term disease markers, such as lesions in brain images, are used in trials to assess a treatment's overall effect. It is not certain if these short-term markers could be reliably used in place of disability worsening in individual patients. Personalized treatment benefit/harm predcition could be easier using these short-term effect.This study will include adult multiple sclerosis patients with relapsing-remitting type. These patients will be participants in clinical trials of drugs available in the market. To answer the above questions, we are going to look at how the benefit or harm of the given treatment in clinical trials changes with different individual patients' characteristics. Many machine-learning and statistical methods will be used to detect the relationship between individual characteristics and treatment-specific response. The predictive ability of these methods for beneficial or harmful outcomes will be evaluated. These outcomes include disability worsening, acute neurological symptoms (relapses), lesions in brain images, adverse events, and infections. The relationship between short-term effects and disability worsening per patient will also be investigated.

[{ "PostingID": 4084, "Title": "NOVARTIS-CFTY720D2301", "Description": "A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis" },{ "PostingID": 4085, "Title": "NOVARTIS-CFTY720D2302", "Description": "A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase" },{ "PostingID": 4089, "Title": "NOVARTIS-CFTY720D2309", "Description": "24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase" },{ "PostingID": 4899, "Title": "NOVARTIS-CFTY720D1201", "Description": "A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis" },{ "PostingID": 4900, "Title": "NOVARTIS-CFTY720D1201E1", "Description": "An Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis" },{ "PostingID": 14593, "Title": "ROCHE-WA21092", "Description": "A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis" },{ "PostingID": 14594, "Title": "ROCHE-WA21093", "Description": "A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis" },{ "PostingID": 14596, "Title": "ROCHE-WA21493", "Description": "Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS" },{ "PostingID": 19692, "Title": "SANOFI-CAMMS223", "Description": "A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis" },{ "PostingID": 19693, "Title": "SANOFI-CAMMS323
(CARE-MS I)", "Description": "A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis" },{ "PostingID": 19694, "Title": "SANOFI-CAMMS32400507
(CAMMS324/ CARE-MS II)", "Description": "A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy" }]