DISEASE MODIFYING THERAPIES WITHDRAWAL IN INACTIVE RELAPSING-REMITTING MULTIPLE SCLEROSIS PATIENTS AGED 55 AND OVER: A MULTICENTRIC, RANDOMIZED, CONTROLLED, OPEN-LABEL CLINICAL TRIAL - TWINS

Conditions

Multiple Sclerosis

Brief summary

Time to first clinical and/or radiological disease activity during a period of 2 years.

Detailed description

Secondary endpoints will be measured by comparing baseline scores/evaluations (M0) with the scores/evaluations at M6, M12, M18, and M24: 1. Kaplan Meier analysis of time to relapse, 2. Annual relapse rate (ARR), 3. Transition to secondary progressive multiple sclerosis according to revised McDonald 2017 criteria, 4. Scores at EDSS, 25Foot/Walk, 9-HPT tests, 5. Scores at CSCT questionnaire, 6. Scores at SEP-59, EQ-5D, Hospital Anxiety and Depression (HAD) and Burden of Treatment (TBQ) Questionnaires, 7. Safety of treatments will be followed by the number and type of adverse or severe adverse events (AE/SAE) throughout the protocol ; Clinical examination, patient questioning; biological analysis in the case of suspected infection, 8. MS comorbidities questionnaire, 9. Average annual cost, incremental ratio cost/effectiveness and cost/utility ratios

Related papers

No related papers found yet.

Interventions

DRUGTecfidera 240 mg gastro-resistant hard capsules

DRUGAVONEX 30 micrograms/0.5ml solution for injection in pre-filled pen.

DRUGAUBAGIO 14 mg film-coated tablets

DRUGPlegridy 63 micrograms + 94 micrograms solution for injection in pre-filled syringe

DRUGBetaferon 250 microgram/ml

DRUGpowder and solvent for solution for injection

DRUGCopaxone 20 mg/ml

DRUGsolution injectable en seringue préremplie

DRUGRebif 44 micrograms solution for injection in pre-filled syringe

DRUGVumerity 231 mg gastro-resistant hard capsules

DRUGExtavia 250 microgram/ml powder and solvent for solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to first clinical and/or radiological disease activity during a period of 2 years.	—

Secondary

Measure	Time frame
Secondary endpoints will be measured by comparing baseline scores/evaluations (M0) with the scores/evaluations at M6, M12, M18, and M24: 1. Kaplan Meier analysis of time to relapse, 2. Annual relapse rate (ARR), 3. Transition to secondary progressive multiple sclerosis according to revised McDonald 2017 criteria, 4. Scores at EDSS, 25Foot/Walk, 9-HPT tests, 5. Scores at CSCT questionnaire, 6. Scores at SEP-59, EQ-5D, Hospital Anxiety and Depression (HAD) and Burden of Treatment (TBQ) Questionnaires, 7. Safety of treatments will be followed by the number and type of adverse or severe adverse events (AE/SAE) throughout the protocol ; Clinical examination, patient questioning; biological analysis in the case of suspected infection, 8. MS comorbidities questionnaire, 9. Average annual cost, incremental ratio cost/effectiveness and cost/utility ratios	—

Measure

Time frame

Secondary endpoints will be measured by comparing baseline scores/evaluations (M0) with the scores/evaluations at M6, M12, M18, and M24: 1. Kaplan Meier analysis of time to relapse, 2. Annual relapse rate (ARR), 3. Transition to secondary progressive multiple sclerosis according to revised McDonald 2017 criteria, 4. Scores at EDSS, 25Foot/Walk, 9-HPT tests, 5. Scores at CSCT questionnaire, 6. Scores at SEP-59, EQ-5D, Hospital Anxiety and Depression (HAD) and Burden of Treatment (TBQ) Questionnaires, 7. Safety of treatments will be followed by the number and type of adverse or severe adverse events (AE/SAE) throughout the protocol ; Clinical examination, patient questioning; biological analysis in the case of suspected infection, 8. MS comorbidities questionnaire, 9. Average annual cost, incremental ratio cost/effectiveness and cost/utility ratios

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Countries

France

Outcome results

None listed