A Prospective Biomarker Study in Active SPMS Subjects Treated With Cladribine Tablets
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|ClinicalTrials.gov Identifier: NCT04550455|
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : January 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Cladribine Tablets||Phase 4|
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period. Maximum allowable time between first screening procedure and first administration of study treatment will be 42 days.
Subjects will have a 28 day run-in period consisting of 2 visits at week -4 and week -2.
Subjects will have a Baseline day 1 visit. Study medication will commerce on the day following this visit.
Additional visits will be at the following time points: week 4, week 8, week 12, week 16, week 24, week 36, week 48, week 52, week 56, week 60, week 72, week 84 and week 96.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Boxes for treatment cycles distributed will be based on weight|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Biomarker Study in Active Secondary Progressive Multiple Sclerosis (SPMS)Subjects Treated With Cladribine Tablets|
|Actual Study Start Date :||September 16, 2020|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2025|
Experimental: Cladribine Tablets
All participants will receive cladribine tablets according to the current United States Federal Food and Drug Administration (FDA) package guidelines.
Drug: Cladribine Tablets
Cladribine tablets will be administered according the current package insert guidelines
Other Name: Mavenclad
- Time to achieve no evidence of disease activity (NEDA) -4 compared to baseline [ Time Frame: 96 weeks ]Currently accepted NEDA -3 criteria of 1) no clinical relapses 2) No new or newly enlarging MRI lesions 3) No progression of disability as measured by the expanded disability status scale (EDSS) with 4) the addition of no increase of serum and/or cerebrospinal fluid (CSF) and/or neurofilament light chain (NfL).
- Decrease of serum/CSF NfL [ Time Frame: 48 weeks ]Estimate of the change in serum/CSF NfL values from pre-treatment level to week 48
- Change in upper body function [ Time Frame: 96 weeks ]Change in score, as recorded in seconds, measured by the 9- hole peg test. Lower Score is better
- Change in Cognitive Function [ Time Frame: 96 weeks ]Change in score as measured by the symbol digit modalities test (SDMT). Minimum Score =0 Maximum score =110. Higher Score is better
- CSF/serum glial fibrillary acidic protein (GFAP) [ Time Frame: 96 weeks ]Values will be exploratory to determine if elevation of this value results in a meaningful change or stabilization over time
- CSF/serum NfL antibody as markers for progressive multiple sclerosis (PMS) [ Time Frame: 96 weeks ]Values will be exploratory to determine if elevation of this value results in a meaningful change or stabilization over time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550455
|Contact: Carol L Frazierfirstname.lastname@example.org|
|Contact: Vineetha Kamathemail@example.com|
|United States, New York|
|Multiple Sclerosis Center of Northeastern New York, P.C.||Recruiting|
|Latham, New York, United States, 12110|
|Contact: Carol L Frazier 518-785-1000 firstname.lastname@example.org|
|Contact: Vineetha Kamath 518-785-1000 email@example.com|
|Principal Investigator: Keith R Edwards, MD|
|Study Director:||Keith R Edwards, M.D.||MS Center of Northeastern New York, P.C.|