Phase 4
Completed N=126
Fingolimod Effect on Cytokine and Chemokine Levels
Source: ClinicalTrials.gov NCT02373098 ↗Enrolled (actual)
126
Serious AEs
4.6%
Results posted
Sep 2019
Primary outcomePrimary: Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA — 212.26; 404.31; 1.15; 1.06 pg/ml — p=0.000
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The main purpose of this study was to measure the serum levels of cytokines and chemokines that are known to increase during multiple sclerosis relapses.
Cytokines are a broad and loose category of small proteins that are important in cell signaling.
The second purpose of the study was to test the cytokine/chemokine changes measured in the 3rd and 6th months on the efficacy parameters.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA |
212.26; 404.31; 1.15; 1.06; 110.8; 139.68 | 0.000 sig |
| PRIMARY Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients |
2048.14; 1610.94; 311.63; 327.63; 281.33; 623.57 | 0.256 |
| PRIMARY Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline |
76.52; 71.92; 11.57; 13.72; 11.04; 10.17 | 0.017 sig |
| SECONDARY Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits |
139.68; 105.42; 105.86; 66.53; 49.98; 149.62 | — |
| SECONDARY Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients |
2048.14; 1610.94; 339.74; 314.75; 311.63; 327.63 | — |
| SECONDARY Absolute Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients |
41.19; 44.91; 13.64; 13.9; 23.23; 22.91 | — |
| SECONDARY Percent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients |
76.52; 71.92; 57.61; 59.29; 11.57; 13.72 | — |
Eligibility Criteria
Key Inclusion Criteria
- Written informed consent must be obtained before the beginning of te study
- Nonresponder RRMS patients
- Last relapse of the patient should be at least 2 months before study entry.
- Last interferon or glatiramer acetate dose of the patient should be at least 1 month before study entry.
Key Exclusion Criteria
- Patients with secondary progressive MS.
- Patients with known contraindications for fingolimod treatment.
- Other coexistent autoimmune diseases
- Pregnant or nursing (lactating) women
Data sourced from ClinicalTrials.gov (NCT02373098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.