A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients

Study ID
STU 062012-022

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • UT Southwestern University Hospital—St. Paul

Contact
Holly Lawrence
214/404-4239
holly.lawrence@utsouthwestern.edu

Principal Investigator
Benjamin Greenberg

Summary

The study will be a Phase 4, prospective, open-label, multicenter, single-country, observational study of anti-JCV antibody negative patients with early RRMS who are initiating treatment with Tysabri. no control group is planned. The end of study is last subject, last visit for final collection of data for the primary outcome.

endpoints are as follows:
* identification of prognostic factors at Baseline that predict overall disease-free status at Month 12, and yearly overall disease-free response factors that predict overall disease-free status at Month 24
* clinical disease-free status (relapse, eDSS) at each analysis timepoint of Months 12, 24, 36, and 48
* identification of prognostic factors at Baseline that predict clinical disease-free status at Month 12, and yearly clinical disease-free response factors that predict clinical disease-free status (relapse, eDSS) in subsequent years at Months 24, 36, and 48
* aRR at each analysis timepoint of Months 12, 24, 36, and 48
* sustained eDSS progression and eDSS improvement (24-week sustained) at each analysis timepoint of Months 12, 24, 36, and 48
* MRi measures: T2, T1, T1 with Gd, and brain atrophy at each analysis timepoint of Months 12, 24, 36, and 48 and change from Baseline
* retinal nerve fiber layer (RnFL) thickness measured by oCT at Month 24 and Month 48 and change from Baseline
* Low and High Contrast Visual acuity assessment at Month 24 and Month 48 and change from Baseline
* cognitive impairment (SDMT) annually at Months 12 to 48 and change from Baseline
* capacity for work (WPai) annually at Months 12 to 48 and change from Baseline
* QoL (MSiS-29) annually at Months 12 to 48 and change from Baseline

Participant Eligibility

1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local patient privacy regulations.
2. Age 18 to 65 years old, inclusive, at time of informed consent.
3. Documented diagnosis of Relapsing Multiple Sclerosis (McDonald 2010 Criteria [Polman et al., 2011]).
4. <3 year disease duration.
5. Must have an EDSS score from 0 to 4.0, inclusive.
6. Known anti-JCV antibody testing within 6 months of screening visit or negative test for anti-JCV antibody at Baseline
7. Must satisfy the approved therapeutic indications for Tysabri.
8. Must be treatment-naive to disease-modifying therapy (DMT) or have been treated with DMTs(including but not limited to Avonex, Betaseron, Rebif, Copaxone, Extavia, or Gilenya) for <=36 months total prior to date of informed consent.
9. Decision to treat with Tysabri must precede enrollment.