Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multip
Background: In people with multiple sclerosis (MS), brain and cerebrospinal fluid (CSF) biomarkers indicate inflammation or disease. Researchers want to see if 4 drugs given alone or combined affect MS biomarkers. They want to see if a change in biomarker levels can predict which drugs a person with MS might respond to
| Condition(s) | Multiple Sclerosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | Background: In people with multiple sclerosis (MS), brain and cerebrospinal fluid (CSF) biomarkers indicate inflammation or disease. Researchers want to see if 4 drugs given alone or combined affect MS biomarkers. They want to see if a change in biomarker levels can predict which drugs a person with MS might respond to. Objective: To see if signs of inflammation in CSF help predict a person s response to different drugs. Eligibility: People ages 18 and older who: * Are in protocol 09-I-0032 * Have progressive MS * Can stand and walk a few steps * Take an MS drug Design: Participants will be screened in protocol 09-I-0032. Participants will take 1 of the 4 study drugs. Researchers will call after 1 month to see how they are doing. Some will start a second drug. They may take each drug or co |
| Who can participate | * INCLUSION CRITERIA: * Enrolled in 09-I-0032 protocol. * Clinically definite MS. * Age \>=18 years at time of study enrollment. * Expanded Disability Status Scale (EDSS) 1.0-7.5. * For progressive MS cohort enrollment: * Documented sustained clinical progression of at least 0.5 CombiWISE points/year on stable therapy (or untreated) * If follow-up is \<3 years, CombiWISE progression slopes are measured by \>= 4 time points regression analysis of CombiWISE values spanning at least 18 months (1.5 years) * If follow-up is \>=3 years, CombiWISE progression slopes are measured by \>= 2 time-points regression analysis of CombiWISE values spanning at least 36 months (3 years) * Because currently only NDS utilizes CombiWISE scale, the progression slopes will be determined via 09-I-0032 natural his |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Locations | Bethesda, Maryland, United States |
| Start date | 2017-08-11 |
| NCT ID | NCT03109288 |
| Official listing | https://clinicaltrials.gov/study/NCT03109288 |