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- Title
(DXT42) Rationale and Design of CLASSIC-MS Study Evaluating Long-Term Efficacy for Patients with Multiple Sclerosis Treated with Cladribine Tablets.
- Authors
Boyko, Alexey; Correale, Jorge; Edan, Gilles; Freedman, Mark S.; Giovannoni, Gavin; Montalban, Xavier; Rammohan, Kottil; Leist, Thomas P.; Stefoski, Dusan; Yamout, Bassem; Garcia-Alonso, Belen; Aydemir, Aida; Verdun di Cantogno, Elisabetta
- Abstract
Background: Cladribine tablets 10 mg (CT; cumulative dose 3.5 mg/ kg over 2 years) has demonstrated efficacy vs placebo over 2 years in CLARITY, CLARITY Extension, and ORACLE-MS, showing sustained effi- cacy without further active treatment in CLARITY Extension. Objectives: CLASSIC-MS will explore long-term efficacy and real-world treatment patterns in patients who participated in these trials. Long-term safety in this population has been assessed in the PREMIERE registry. Methods: CLASSIC- MS is an exploratory phase 4 study of patients with MS, or those with a first clinical demyelinating event enrolled into the phase 3 trials and who received ≥1 course of CT or placebo (N = 1946). Following prebaseline screening and assessment for eligibility, long-term retrospective data will be obtained from medical records at study visit 1; prospective data will be collected at study visits 1 and 2. Patients will be enrolled for 17 months from approximately Q3 2019 to Q4 2020. Last patient last visit is expected in Q1 2021. Primary objective: evaluation of long-term mobility after treatment with CT or placebo. Secondary objective: assess differences in clinical and magnetic resonance imaging characteristics in long-term responders vs nonresponders. Tertiary end points: real-world treatment patterns, durability of clinical outcomes, quality of life and cognitive outcomes, influence of high-disease activity on long-term response, and differences in genetics between long-term responders and those who are not. Results: In 2018, a second feasibility survey was sent to 225 centers; 110 centers provided positive responses and were included, representing 48% of sites originally enrolled in the phase 3 studies. In total 115 centers were not included (81 were not willing to participate; 13 dropped; 16 were nonresponders; 5 were rejected). Conclusions: CLASSIC-MS will provide valuable information on the long-term efficacy of CT in patients with MS.
- Subjects
ADENOSINES; CONFERENCES &; conventions; MULTIPLE sclerosis; TREATMENT effectiveness
- Publication
International Journal of MS Care, 2020, Vol 22, Issue S2, p30
- ISSN
1537-2073
- Publication type
Article