Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis
NCT03963375
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
St Louis, Missouri, United States
View Trial DetailsNCT Number: NCT03854123
Little is known about old MS patients. In a previous work, systematic search in Bordeaux, Strasbourg and Dijon university hospital regional MS center databases European Database for Multiple Sclerosis (EDMUS) retrieved 2% of 75 years old or older Multiple Sclerosis (MS) patients in the 3 databases. Data analysis showed that MS may switch off in the very old patients with mild progression and very few relapses. The project is to continue this preliminary work and extend it with a systematic study of MS in the elderly.
The scientific aims: To add new insights into long lasting MS natural history in the growing population of elderly patients with MS.
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Notify Me75 year–77 year
All sexes
Observational
CHU de Bordeaux - Pellegrin - service de neurologie, Bordeaux, France
75 to 77 years old MS patients whose disease began at 65 years old or earlier will be retrieved from the "Observatoire français de la sclérose en plaques" (OFSEP) which includes more than 50 000 MS patients in France. Accuracy of these patients' data from 65 to 75 years old will be thereafter checked and completed in 3 French MS centers: Lyon, Rennes and Bordeaux, participating to this database directly from the patients' clinical files. From these 3 MS centers around 150 MS patients from 75 to 77 years old are expected to be analysed on site.
The data wich will be retrieved for these patients are: irreversible disability status scale progression, relapses, Magnetic Resonance Imaging (MRI) data, CSF data, Lublin classification of type of MS, McDonald 2005 and 2010 criteria, date and age at beginning of progression, characteristics and modality of relapses and clinical impairment at the beginning of the disease, treatments used, treatment failures and side effects, co morbidity, Barthel index, EuroQol-5D (EQ-5D), cognitive impairment (SDMT test), social life data and socio economic data. To the investigator's knowledge this will be the first systematic description of very old MS patients with data on long term natural history of MS and characteristics in this population of elderly MS patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At inclusion (day 0)
Time to reach the irreversible Kurtzke disability status scale (DSS) score 4, 6 and 7
Time frame: At inclusion (day 0)
Time frame: At inclusion (day 0)
Clinical conversion to secondary progressive MS date
Time frame: At inclusion (day 0)
Number of lesions on T2 sequence if <9, number of new T2 lesions, Number of Gadolinium enhancing lesions, T1-Hypointense Lesions (T1 Black Holes), MRI Barkhof Criteria and number of periventricular lesions if <3,
Time frame: At inclusion (day 0)
Distance walked (with or without help)
Time frame: At inclusion (day 0)
Barthel index
Time frame: At inclusion (day 0)
sex
Time frame: At inclusion (day 0)
age
Time frame: At inclusion (day 0)
department of residence
Time frame: At inclusion (day 0)
Treatments of multiple sclerosis
Time frame: At inclusion (day 0)
Failures treatments of multiple sclerosis
Time frame: At inclusion (day 0)
Side effects of treatments and other concomitant treatments
Time frame: At inclusion (day 0)
EQ-5D Instruments
Time frame: At inclusion (day 0)
Symbol digit modalities test (SDMT) test
University Hospital, Bordeaux
Other
Acronym: OLDMUS
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