SHS_543148 QIAP FJHU 18046

A Pragmatic Trial to Evaluate the Intermediate-term Effects of Early, Aggressive Versus Escalation Therapy in People With Multiple Sclerosis

Inclusion Criteria:

-Aged 18-60 years
-Meets 2017 McDonald criteria for relapsing-remitting MS [patients with clinically isolated syndrome (CIS) are not eligible]
-Must be EITHER John Cunningham (JC) virus antibody negative or low positive (index antibody titer <0.9), OR negative for: Hepatitis B and C, tuberculosis
-HIV negative
-No chemotherapy in past year; if patient has prior history of chemotherapy or malignancy, documentation in chart explaining why potential risks of higher-efficacy therapy are justified

Exclusion Criteria:

-Prior treatment with rituximab, ocrelizumab, alemtuzumab, mitoxantrone or cladribine
-Prior treatment with any other MS DMT for more than 6 months
-Prior treatment with experimental aggressive therapies (e.g., T-cell vaccine, total lymphoid radiation, stem cells)
-Treatment with teriflunomide within past 2 years (even for ≤ 6 months), unless rapid wash out done (i.e., with cholestyramine or activated charcoal)
-Treatment in the past 6 months with any MS DMT
-Prior treatment with any other investigational immune-modulating /suppressing drug for MS not listed above
-Pregnant or breast-feeding
-Women of child-bearing age who are planning or strongly considering conception during the study time frame

Sexes Eligible for Study: All

Ages: 18 Years to 60 Years (Adult)

Accepts Healthy Volunteers: No
N/A
NCT03500328
Neurosciences
Multiple Sclerosis
Peiqing Qian, M.D.
Johns Hopkins University
Yuriko Courtney
  • Swedish Medical Center