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To study the impact of cladribine on peripheral and intrathecal B-cell, plasma cells, T cells and Tregs
Primary: To quantify the temporal changes of memory B cells (CD19+/CD27+/IgD-/+), plasmablasts (CD19-/CD138+/CD38+) and T cells (CD4/CD45RA-/+, CCR7-/+, CD8+/CD45RA-/+/CCR7-/+), Tregs (CD4/CD8)/CD25+/CD127-/Fox3 P+) in the peripheral venous blood of pwMS with RRMS over 96w of treatment with oral cladribine.
These will be compared to the populations of non-memory or class-switched B cells (immature/transitional B cells CD10+/CD38+/CD19+, immature regulatory B cells CD10+/CD38+/CD19+/CD24+/IL-10+, mature B cells CD10-/CD38+/CD19+).
Secondary:
To study the effects of oral cladribine on:
To compare CSF OCB positivity and CSF light chain levels with a contemporary control group of alemtuzumab treated pwMS (historical data).
Tertiary:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cladribine (Mavenclad, Merck Serono Ltd) | 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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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Class-switched Memory B Cells From Baseline to Week 96 nh | Percent change from baseline to Week 96 in class-switched memory B cells (CD19+/CD27+/IgD-) in participants with RRMS treated with oral cladribine. | Baseline to week 96 |
| Percent Change in Non Class-switched Memory B Cells From Baseline to Week 96 | 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. | Baseline to week 96 |
| Percent Change in Plasmablast From Baseline to Week 96 | Percent change from baseline to Week 96 in plasmablasts (CD19+/CD27+/CD38+) in participants with RRMS treated with oral cladribine. | Baseline to week 96 |
| Percent Change in Transitional B Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in transitional B cells (CD19+ IgD+ CD10+ CD27-) in participants with RRMS treated with oral cladribine. | Baseline to week 96 |
| Percent Change in Regulatory B Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in regulatory B cells (CD19+/CD24+/CD38+) in participants with RRMS treated with oral cladribine. | Baseline to week 96 |
| Percent Change in CD4+ Central Memory T Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD4+ central memory T cells (CD45RA- CCR7+) in participants with RRMS treated with oral cladribine. | Baseline to week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in CSF of κ Free Light Chain (KFLC) From Baseline to Week 48 and Week 96 | The 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Relapsing-remitting MS
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts Health NHS Trust | London | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
3 male, 7 female
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| ID | Title | Description |
|---|---|---|
| BG000 | Cladribine (Mavenclad, Merck Serono Ltd) | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Class-switched Memory B Cells From Baseline to Week 96 nh | Percent change from baseline to Week 96 in class-switched memory B cells (CD19+/CD27+/IgD-) in participants with RRMS treated with oral cladribine. | 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. | Posted | Median | Full Range | % change | Baseline to week 96 |
|
96 weeks
In this observational study, adverse events (AEs) and serious adverse events (SAEs) are not collected in the same manner as interventional studies. Observational studies do not involve interventions administered as part of the research, and therefore, the definitions and reporting requirements for AEs and SAEs are not directly applicable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cladribine (Mavenclad, Merck Serono Ltd) | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sharmilee Gnanapavan | Queen Mary University | 02073777000 | 42157 | sharmilee.gnanapavan@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2019 | Dec 12, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 28, 2019 | Dec 12, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Percent Change in CD4+ Naive T Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD4+ naive T cells (CD45RA+ CCR7+) in participants with RRMS treated with oral cladribine. | Baseline to week 96 |
| Percent Change in CD4+ TEMRA Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD4+ TEMRA cells (CD45RA+ CCR7-) in participants with RRMS treated with oral cladribine. | Baseline to week 96 |
| Percent Change in CD4+ Effector Memory T Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD4+ effector memory T cells (CD45RA- CCR7-) in participants with RRMS treated with oral cladribine. | Baseline to week 96 |
| Percent Change in CD8+ Central Memory T Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD8+ central memory T cells (CD45RA- CCR7+) in participants with RRMS treated with oral cladribine. | Baseline to week 96 |
| Percent Change in CD8+ Naive T Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD8+ naive T cells (CD45RA+ CCR7+) in participants with RRMS treated with oral cladribine. | Baseline to week 96 |
| Percent Change in CD8+ TEMRA Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD8+ TEMRA cells (CD45RA+ CCR7-) in participants with RRMS treated with oral cladribine. | Baseline to week 96 |
| Percent Change in CD8+ TEM Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD8+ effector memory T cells (CD45RA- CCR7-) in participants with RRMS treated with oral cladribine. | Baseline to week 96 |
| Percent Change in Regulatory T Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in regulatory T cells (CD4+ CD25+ FOXP3+) in participants with RRMS treated with oral cladribine. | Baseline to week 96 |
| Baseline to week 96 |
| Change in CSF Oligoclonal Band (OCB) Positivity From Baseline to Week 48 and Week 96 | CSF 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 | Baseline to week 96 |
| Changes in CSF of λ Free Light Chain (LFLC) Index From Baseline to Week 48 and Week 96 | The 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. | Baseline to week 96 |
| Change in CSF CXCL-13 Levels From Baseline to Week 96 | CXCL-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. | Baseline to week 96 |
| Change in Urine Neopterin Levels From Baseline to Week 96 | Urine 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 | Baseline to week 96 |
| Change in CSF Neurofilament Light Chain (NfL) Levels From Baseline to Week 96 | CSF 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 | Baseline to 96 weeks |
| Change in CSF Soluble CD138 Levels From Baseline to Week 96 | Soluble 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. | Baseline to week 96 |
| Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96 | Cerebrospinal 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. | Baseline to week 96 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
|
|
| Secondary | Changes in CSF of κ Free Light Chain (KFLC) From Baseline to Week 48 and Week 96 | The 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. | Posted | Mean | Standard Deviation | kFLCIndex | Baseline to week 96 |
|
|
|
| Secondary | Change in CSF Oligoclonal Band (OCB) Positivity From Baseline to Week 48 and Week 96 | CSF 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 | Posted | Count of Participants | Participants | Baseline to week 96 |
|
|
|
| Secondary | Changes in CSF of λ Free Light Chain (LFLC) Index From Baseline to Week 48 and Week 96 | The 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. | Posted | Mean | Standard Deviation | LFLCIndex | Baseline to week 96 |
|
|
|
| Secondary | Change in CSF CXCL-13 Levels From Baseline to Week 96 | CXCL-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. | Posted | Mean | Standard Deviation | pg/ml | Baseline to week 96 |
|
|
|
| Secondary | Change in Urine Neopterin Levels From Baseline to Week 96 | Urine 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 | Posted | Mean | Standard Deviation | pg/ml | Baseline to week 96 |
|
|
|
| Primary | Percent Change in Non Class-switched Memory B Cells From Baseline to Week 96 | 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. | 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. | Posted | Median | Full Range | % change | Baseline to week 96 |
|
|
|
| Primary | Percent Change in Plasmablast From Baseline to Week 96 | Percent change from baseline to Week 96 in plasmablasts (CD19+/CD27+/CD38+) in participants with RRMS treated with oral cladribine. | 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. | Posted | Median | Full Range | % change | Baseline to week 96 |
|
|
|
| Primary | Percent Change in Transitional B Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in transitional B cells (CD19+ IgD+ CD10+ CD27-) in participants with RRMS treated with oral cladribine. | 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. | Posted | Median | Full Range | % change | Baseline to week 96 |
|
|
|
| Primary | Percent Change in Regulatory B Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in regulatory B cells (CD19+/CD24+/CD38+) in participants with RRMS treated with oral cladribine. | 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. | Posted | Median | Full Range | % change | Baseline to week 96 |
|
|
|
| Primary | Percent Change in CD4+ Central Memory T Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD4+ central memory T cells (CD45RA- CCR7+) in participants with RRMS treated with oral cladribine. | 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. | Posted | Median | Full Range | % change | Baseline to week 96 |
|
|
|
| Primary | Percent Change in CD4+ Naive T Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD4+ naive T cells (CD45RA+ CCR7+) in participants with RRMS treated with oral cladribine. | 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. | Posted | Median | Full Range | % change | Baseline to week 96 |
|
|
|
| Primary | Percent Change in CD4+ TEMRA Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD4+ TEMRA cells (CD45RA+ CCR7-) in participants with RRMS treated with oral cladribine. | 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. | Posted | Median | Full Range | % change | Baseline to week 96 |
|
|
|
| Primary | Percent Change in CD4+ Effector Memory T Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD4+ effector memory T cells (CD45RA- CCR7-) in participants with RRMS treated with oral cladribine. | 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. | Posted | Median | Full Range | % change | Baseline to week 96 |
|
|
|
| Primary | Percent Change in CD8+ Central Memory T Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD8+ central memory T cells (CD45RA- CCR7+) in participants with RRMS treated with oral cladribine. | 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. | Posted | Median | Full Range | Percentage change | Baseline to week 96 |
|
|
|
| Primary | Percent Change in CD8+ Naive T Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD8+ naive T cells (CD45RA+ CCR7+) in participants with RRMS treated with oral cladribine. | 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. | Posted | Median | Full Range | % change | Baseline to week 96 |
|
|
|
| Primary | Percent Change in CD8+ TEMRA Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD8+ TEMRA cells (CD45RA+ CCR7-) in participants with RRMS treated with oral cladribine. | 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. | Posted | Median | Full Range | % change | Baseline to week 96 |
|
|
|
| Primary | Percent Change in CD8+ TEM Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in CD8+ effector memory T cells (CD45RA- CCR7-) in participants with RRMS treated with oral cladribine. | 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. | Posted | Median | Full Range | % change | Baseline to week 96 |
|
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| Primary | Percent Change in Regulatory T Cells From Baseline to Week 96 | Percent change from baseline to Week 96 in regulatory T cells (CD4+ CD25+ FOXP3+) in participants with RRMS treated with oral cladribine. | 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. | Posted | Median | Full Range | % change | Baseline to week 96 |
|
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| Secondary | Change in CSF Neurofilament Light Chain (NfL) Levels From Baseline to Week 96 | CSF 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 | Posted | Median | Inter-Quartile Range | pg/ml | Baseline to 96 weeks |
|
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| Secondary | Change in CSF Soluble CD138 Levels From Baseline to Week 96 | Soluble 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. | Posted | Mean | Standard Deviation | pg/ml | Baseline to week 96 |
|
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| Secondary | Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96 | Cerebrospinal 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. | Posted | Mean | Standard Deviation | pg/ml | Baseline to week 96 |
|
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Participants OCB-negative at all timepoints |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| CSF IL-10 at baseline |
|
| CSF IL-10 at 48 wks |
|
| CSF IL-10 at 96 wks |
|
| CSF IL12p70 at baseline |
|
| CSF IL12p70 at 48 WKS |
|
| CSF IL12p70 at 96 WKS |
|
| CSF IL13 at baseline CSF IL13 CSF IL13 baseline |
|
| CSF IL13 at 48 wks |
|
| CSF IL13 at 96 wks |
|
| CSF IL-1b at baseline |
|
| CSF IL-1b at 48wks |
|
| CSF IL-1b at 96wks |
|
| CSF IL-2 at baseline |
|
| CSF IL-2 at 48 WKS |
|
| CSF IL-2 at 96 WKS |
|
| CSF IL-4 at baseline |
|
| CSF IL-4 at 48wks |
|
| CSF IL-4 at 96wks |
|
| CSF IL-5 at baseline |
|
| CSF IL-5 at 48wks |
|
| CSF IL-5 at 96wks |
|
| CSF IL-8 at baseline |
|
| CSF IL-8 at 48 wks |
|
| CSF IL-8 at 96 wks |
|
| CSF TNF-a at baseline |
|
| CSF TNF-a at 48 wks |
|
| CSF TNF-a at 96 wks |
|