Trial Outcomes & Findings for Oral Cladribine B-cell Study (NCT NCT06415864)
NCT ID: NCT06415864
Last Updated: 2026-02-04
Results Overview
Percent change from baseline to Week 96 in non class-switched memory B cells (CD19+/CD27+/IgD+) in participants with RRMS treated with oral cladribine.
COMPLETED
10 participants
Baseline to week 96
2026-02-04
Participant Flow
Participant milestones
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 96 weeks, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Cladribine B-cell Study
Baseline characteristics by cohort
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=41 Participants
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=41 Participants
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Age, Categorical
>=65 years
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0 Participants
n=41 Participants
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Sex: Female, Male
Female
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7 Participants
n=41 Participants
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Sex: Female, Male
Male
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3 Participants
n=41 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=41 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Black or African American
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4 Participants
n=41 Participants
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Race (NIH/OMB)
White
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5 Participants
n=41 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=41 Participants
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Region of Enrollment
United Kingdom
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10 Participants
n=41 Participants
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PRIMARY outcome
Timeframe: Baseline to week 96Population: B-cell and T-cell subsets were quantified by flow cytometry at baseline and Week 96. Percent change was calculated as \[(Week 96 - baseline) / baseline\] × 100.
Percent change from baseline to Week 96 in class-switched memory B cells (CD19+/CD27+/IgD-) in participants with RRMS treated with oral cladribine.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Percent Change in Class-switched Memory B Cells From Baseline to Week 96 nh
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-62.8 % change
Interval -99.98 to 160.0
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PRIMARY outcome
Timeframe: Baseline to week 96Population: B-cell and T-cell subsets were quantified by flow cytometry at baseline and Week 96. Percent change was calculated as \[(Week 96 - baseline) / baseline\] × 100.
Percent change from baseline to Week 96 in non class-switched memory B cells (CD19+/CD27+/IgD+) in participants with RRMS treated with oral cladribine.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Percent Change in Non Class-switched Memory B Cells From Baseline to Week 96
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-85.3 % change
Interval -99.98 to 134.44
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PRIMARY outcome
Timeframe: Baseline to week 96Population: B-cell and T-cell subsets were quantified by flow cytometry at baseline and Week 96. Percent change was calculated as \[(Week 96 - baseline) / baseline\] × 100.
Percent change from baseline to Week 96 in plasmablasts (CD19+/CD27+/CD38+) in participants with RRMS treated with oral cladribine.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Percent Change in Plasmablast From Baseline to Week 96
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117.2 % change
Interval -87.3 to 2250.0
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PRIMARY outcome
Timeframe: Baseline to week 96Population: B-cell and T-cell subsets were quantified by flow cytometry at baseline and Week 96. Percent change was calculated as \[(Week 96 - baseline) / baseline\] × 100.
Percent change from baseline to Week 96 in transitional B cells (CD19+ IgD+ CD10+ CD27-) in participants with RRMS treated with oral cladribine.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Percent Change in Transitional B Cells From Baseline to Week 96
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858.6 % change
Interval -86.05 to 2350.0
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PRIMARY outcome
Timeframe: Baseline to week 96Population: B-cell and T-cell subsets were quantified by flow cytometry at baseline and Week 96. Percent change was calculated as \[(Week 96 - baseline) / baseline\] × 100.
Percent change from baseline to Week 96 in regulatory B cells (CD19+/CD24+/CD38+) in participants with RRMS treated with oral cladribine.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Percent Change in Regulatory B Cells From Baseline to Week 96
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648.3 % change
Interval -93.52 to 46650.0
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PRIMARY outcome
Timeframe: Baseline to week 96Population: B-cell and T-cell subsets were quantified by flow cytometry at baseline and Week 96. Percent change was calculated as \[(Week 96 - baseline) / baseline\] × 100.
Percent change from baseline to Week 96 in CD4+ central memory T cells (CD45RA- CCR7+) in participants with RRMS treated with oral cladribine.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Percent Change in CD4+ Central Memory T Cells From Baseline to Week 96
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-55 % change
Interval -94.64 to 226.88
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PRIMARY outcome
Timeframe: Baseline to week 96Population: B-cell and T-cell subsets were quantified by flow cytometry at baseline and Week 96. Percent change was calculated as \[(Week 96 - baseline) / baseline\] × 100.
Percent change from baseline to Week 96 in CD4+ naive T cells (CD45RA+ CCR7+) in participants with RRMS treated with oral cladribine.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Percent Change in CD4+ Naive T Cells From Baseline to Week 96
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-47.1 % change
Interval -99.74 to 1472.97
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PRIMARY outcome
Timeframe: Baseline to week 96Population: B-cell and T-cell subsets were quantified by flow cytometry at baseline and Week 96. Percent change was calculated as \[(Week 96 - baseline) / baseline\] × 100.
Percent change from baseline to Week 96 in CD4+ TEMRA cells (CD45RA+ CCR7-) in participants with RRMS treated with oral cladribine.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Percent Change in CD4+ TEMRA Cells From Baseline to Week 96
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30.4 % change
Interval -96.95 to 1560.0
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PRIMARY outcome
Timeframe: Baseline to week 96Population: B-cell and T-cell subsets were quantified by flow cytometry at baseline and Week 96. Percent change was calculated as \[(Week 96 - baseline) / baseline\] × 100.
Percent change from baseline to Week 96 in CD4+ effector memory T cells (CD45RA- CCR7-) in participants with RRMS treated with oral cladribine.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Percent Change in CD4+ Effector Memory T Cells From Baseline to Week 96
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0.82 % change
Interval -96.9 to 234.25
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PRIMARY outcome
Timeframe: Baseline to week 96Population: B-cell and T-cell subsets were quantified by flow cytometry at baseline and Week 96. Percent change was calculated as \[(Week 96 - baseline) / baseline\] × 100.
Percent change from baseline to Week 96 in CD8+ central memory T cells (CD45RA- CCR7+) in participants with RRMS treated with oral cladribine.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Percent Change in CD8+ Central Memory T Cells From Baseline to Week 96
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26 Percentage change
Interval -94.24 to 251.57
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PRIMARY outcome
Timeframe: Baseline to week 96Population: B-cell and T-cell subsets were quantified by flow cytometry at baseline and Week 96. Percent change was calculated as \[(Week 96 - baseline) / baseline\] × 100.
Percent change from baseline to Week 96 in CD8+ naive T cells (CD45RA+ CCR7+) in participants with RRMS treated with oral cladribine.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Percent Change in CD8+ Naive T Cells From Baseline to Week 96
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-25 % change
Interval -89.67 to 2050.0
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PRIMARY outcome
Timeframe: Baseline to week 96Population: B-cell and T-cell subsets were quantified by flow cytometry at baseline and Week 96. Percent change was calculated as \[(Week 96 - baseline) / baseline\] × 100.
Percent change from baseline to Week 96 in CD8+ TEMRA cells (CD45RA+ CCR7-) in participants with RRMS treated with oral cladribine.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Percent Change in CD8+ TEMRA Cells From Baseline to Week 96
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60.81 % change
Interval -52.84 to 3006.25
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PRIMARY outcome
Timeframe: Baseline to week 96Population: B-cell and T-cell subsets were quantified by flow cytometry at baseline and Week 96. Percent change was calculated as \[(Week 96 - baseline) / baseline\] × 100.
Percent change from baseline to Week 96 in CD8+ effector memory T cells (CD45RA- CCR7-) in participants with RRMS treated with oral cladribine.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Percent Change in CD8+ TEM Cells From Baseline to Week 96
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4.56 % change
Interval -95.53 to 726.48
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PRIMARY outcome
Timeframe: Baseline to week 96Population: B-cell and T-cell subsets were quantified by flow cytometry at baseline and Week 96. Percent change was calculated as \[(Week 96 - baseline) / baseline\] × 100.
Percent change from baseline to Week 96 in regulatory T cells (CD4+ CD25+ FOXP3+) in participants with RRMS treated with oral cladribine.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Percent Change in Regulatory T Cells From Baseline to Week 96
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40.02 % change
Interval -88.52 to 680.0
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SECONDARY outcome
Timeframe: Baseline to week 96The CSF κ Free Light Chain (KFLC) Index and λ Free Light Chain (LFLC) Index were measured at baseline, Week 48, and Week 96. KFLC and LFLC concentrations in cerebrospinal fluid and serum were obtained using Optilite. The KFLC Index and LFLC Index were calculated as (CSF FLC / serum FLC) ÷ (CSF albumin / serum albumin). These indices provide quantitative measures of intrathecal free light chain synthesis. Values are continuous laboratory measurements and do not use a score or scale.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Changes in CSF of κ Free Light Chain (KFLC) From Baseline to Week 48 and Week 96
KFLC Index at baseline
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164.5 kFLCIndex
Standard Deviation 227.1
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Changes in CSF of κ Free Light Chain (KFLC) From Baseline to Week 48 and Week 96
KFLC Index at week 48
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71.3 kFLCIndex
Standard Deviation 82.74
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Changes in CSF of κ Free Light Chain (KFLC) From Baseline to Week 48 and Week 96
KFLC Index at Week 96
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64.4 kFLCIndex
Standard Deviation 67.34
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SECONDARY outcome
Timeframe: Baseline to week 96CSF and matched serum samples were analysed for IgG oligoclonal bands using isoelectric focusing followed by immunoblotting. OCB positivity was defined as ≥1 IgG band present in CSF but absent in serum (CSF-restricted bands). Reported values include the number of OCB-positive and OCB-negative participants at each time point (baseline, Week 48, Week 96). Higher values indicate increased intrathecal IgG synthesis
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Change in CSF Oligoclonal Band (OCB) Positivity From Baseline to Week 48 and Week 96
Participants with decreased OCB bands (Baseline → Week 96)
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4 Participants
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Change in CSF Oligoclonal Band (OCB) Positivity From Baseline to Week 48 and Week 96
Participants with unchanged OCB bands
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2 Participants
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Change in CSF Oligoclonal Band (OCB) Positivity From Baseline to Week 48 and Week 96
Participants with increased OCB bands
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3 Participants
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Change in CSF Oligoclonal Band (OCB) Positivity From Baseline to Week 48 and Week 96
Participants OCB-negative at all timepoints
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1 Participants
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SECONDARY outcome
Timeframe: Baseline to week 96The CSF κ Free Light Chain (KFLC) Index and λ Free Light Chain (LFLC) Index were measured at baseline, Week 48, and Week 96. KFLC and LFLC concentrations in cerebrospinal fluid and serum were obtained using Optilite. The KFLC Index and LFLC Index were calculated as (CSF FLC / serum FLC) ÷ (CSF albumin / serum albumin). These indices provide quantitative measures of intrathecal free light chain synthesis. Values are continuous laboratory measurements and do not use a score or scale.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Changes in CSF of λ Free Light Chain (LFLC) Index From Baseline to Week 48 and Week 96
LFLC Index at baseline
|
31.94 LFLCIndex
Standard Deviation 25.47
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Changes in CSF of λ Free Light Chain (LFLC) Index From Baseline to Week 48 and Week 96
LFLC Index at week 48
|
29.48 LFLCIndex
Standard Deviation 25.14
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Changes in CSF of λ Free Light Chain (LFLC) Index From Baseline to Week 48 and Week 96
LFLC Index at Week 96
|
27.18 LFLCIndex
Standard Deviation 25.86
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SECONDARY outcome
Timeframe: Baseline to week 96CXCL-13 concentrations in cerebrospinal fluid (CSF) were measured at baseline, Week 48, and Week 96 using immunoassay methods. Values are continuous laboratory measurements and are reported numerically (mean and standard deviation). No scoring system or clinical scale applies.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Change in CSF CXCL-13 Levels From Baseline to Week 96
CXCL-13 at baseline
|
88.6 pg/ml
Standard Deviation 68.4
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Change in CSF CXCL-13 Levels From Baseline to Week 96
CXCL-13 at 48 weeks
|
39.4 pg/ml
Standard Deviation 35.2
|
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Change in CSF CXCL-13 Levels From Baseline to Week 96
CXCL-13 at 96 weeks
|
19.1 pg/ml
Standard Deviation 11.7
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SECONDARY outcome
Timeframe: Baseline to week 96Urine neopterin concentrations were measured at baseline, Week 48, and Week 96 using immunoassay methods. Values are continuous laboratory measurements and are reported numerically (mean and standard deviation). No scoring system or clinical scale applied
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
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|---|---|
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Change in Urine Neopterin Levels From Baseline to Week 96
Neopterin at 96 weeks
|
136.99 pg/ml
Standard Deviation 114.18
|
|
Change in Urine Neopterin Levels From Baseline to Week 96
Neopterin at baseline
|
224.64 pg/ml
Standard Deviation 268.06
|
|
Change in Urine Neopterin Levels From Baseline to Week 96
Neopterin at 48 weeks
|
355.87 pg/ml
Standard Deviation 566.27
|
SECONDARY outcome
Timeframe: Baseline to 96 weeksCSF neurofilament light chain (NfL) concentrations were measured at baseline, Week 48, and Week 96 using immunoassay methods. NfL is reported as a continuous laboratory value. Results are presented as numerical measurements (mean and standard deviation). No clinical scoring system or scale applies
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
|
|---|---|
|
Change in CSF Neurofilament Light Chain (NfL) Levels From Baseline to Week 96
NFL at baseline
|
534.42 pg/ml
Interval 316.3 to 1249.0
|
|
Change in CSF Neurofilament Light Chain (NfL) Levels From Baseline to Week 96
NFL at 48wks
|
271.77 pg/ml
Interval 190.2 to 368.1
|
|
Change in CSF Neurofilament Light Chain (NfL) Levels From Baseline to Week 96
NFL at 96 wks
|
301.13 pg/ml
Interval 178.2 to 469.8
|
SECONDARY outcome
Timeframe: Baseline to week 96Soluble CD138 concentrations in cerebrospinal fluid (CSF) were measured at baseline, Week 48, and Week 96 using immunoassay methods. Values are continuous laboratory measurements and are reported numerically (mean and standard deviation). No clinical scoring system or scale applies.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
|
|---|---|
|
Change in CSF Soluble CD138 Levels From Baseline to Week 96
sCD138 at baseline
|
0.25 pg/ml
Standard Deviation 0.28
|
|
Change in CSF Soluble CD138 Levels From Baseline to Week 96
sCD138 at week 48
|
0.14 pg/ml
Standard Deviation 0.20
|
|
Change in CSF Soluble CD138 Levels From Baseline to Week 96
sCD138 at week 96
|
0.09 pg/ml
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Baseline to week 96Cerebrospinal fluid (CSF) cytokines and chemokines were measured at baseline, Week 48, and Week 96 using immunoassays. Analytes included IFN-γ, IL-10, IL-12p70, IL-13, IL-1β, IL-2, IL-4, IL-5, IL-8, and TNF-α. Values are continuous laboratory measurements and are reported numerically (mean and standard deviation). No clinical scoring system or scale applies. Results for each analyte are presented in separate rows of the results table.
Outcome measures
| Measure |
Cladribine (Mavenclad, Merck Serono Ltd)
n=10 Participants
In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight
|
|---|---|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IFN-y at baseline
|
1.08 pg/ml
Standard Deviation 0.75
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IFN-Y at 48 wks
|
0.99 pg/ml
Standard Deviation 0.90
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IFN-Y at 96 wks
|
1.00 pg/ml
Standard Deviation 1.22
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-10 at baseline
|
0.11 pg/ml
Standard Deviation 0.11
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-10 at 48 wks
|
0.13 pg/ml
Standard Deviation 0.19
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-10 at 96 wks
|
0.05 pg/ml
Standard Deviation 0.04
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL12p70 at baseline
|
0.015 pg/ml
Standard Deviation 0.03
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL12p70 at 48 WKS
|
0.01 pg/ml
Standard Deviation 0.01
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL12p70 at 96 WKS
|
0.02 pg/ml
Standard Deviation 0.03
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL13 at baseline CSF IL13 CSF IL13 baseline
|
0.23 pg/ml
Standard Deviation 0.27
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL13 at 48 wks
|
0.22 pg/ml
Standard Deviation 0.24
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL13 at 96 wks
|
0.31 pg/ml
Standard Deviation 0.20
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-1b at baseline
|
0.11 pg/ml
Standard Deviation 0.05
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-1b at 48wks
|
0.11 pg/ml
Standard Deviation 0.05
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-1b at 96wks
|
0.08 pg/ml
Standard Deviation 0.04
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-2 at baseline
|
0.02 pg/ml
Standard Deviation 0.03
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-2 at 48 WKS
|
0.02 pg/ml
Standard Deviation 0.03
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-2 at 96 WKS
|
0.02 pg/ml
Standard Deviation 0.02
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-4 at baseline
|
0.0 pg/ml
Standard Deviation 0.0
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-4 at 48wks
|
0.0 pg/ml
Standard Deviation 0.0
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-4 at 96wks
|
0.0 pg/ml
Standard Deviation 0.0
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-5 at baseline
|
0.18 pg/ml
Standard Deviation 0.09
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-5 at 48wks
|
0.25 pg/ml
Standard Deviation 0.13
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-5 at 96wks
|
0.21 pg/ml
Standard Deviation 0.14
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-8 at baseline
|
27.11 pg/ml
Standard Deviation 13.05
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-8 at 48 wks
|
29.65 pg/ml
Standard Deviation 9.56
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF IL-8 at 96 wks
|
25.56 pg/ml
Standard Deviation 12.74
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF TNF-a at baseline
|
0.05 pg/ml
Standard Deviation 0.04
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF TNF-a at 48 wks
|
0.04 pg/ml
Standard Deviation 0.05
|
|
Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96
CSF TNF-a at 96 wks
|
0.06 pg/ml
Standard Deviation 0.06
|
Adverse Events
Cladribine (Mavenclad, Merck Serono Ltd)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place