NL-OMON42490
Completed
Phase 4
Characterization of the immuno-modulatory effects of Tecfidera in multiple sclerosis patients: exploration of drug mechanism and methodological feasibility. - Characterization immuno-modulatory effects of Tecfidera: feasibility study.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Reduced lymphocyte count. Reduced white bloodcell count.
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 16
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria, MS patients
- •\- male and female subjects;
- •\- minimal age 18 years at the time of informed consent;
- •\- confirmed relapsing remitting multiple sclerosis (RRMS) patients, with:
- •\- a diagnosis of RRMS according to the revised McDonald criteria;
- •\- a baseline score of 0 to 5\.0 on the Expanded Disability Status Scale;
- •\- patients on Tecfidera treatment for at least 6 months;
- •\- ability to participate, and willingness to give written informed consent and to comply with the study restrictions and protocol requirements.;Inclusion criteria, healthy subjects
- •\- healthy male and female subjects;
- •\- minimal age of 18 years at the time of informed consent;
Exclusion Criteria
- •Exclusion criteria, MS patients
- •\- positive test result for human immunodeficiency virus antibody (HIV\-Ab), hepatitis C antibody (HCV\-Ab), and/or hepatitis B surface antigen (HbsAg) at screening;
- •\- evidence of any active or chronic disease or condition, other than MS (based on medical history, a physical examination, vital signs, 12 lead ECG, haematology, blood chemistry and urinalysis) that could, in the opinion of the investigator, interfere with the conduct of the study or the study objectives, or pose an unacceptable risk to the subject;
- •\- a treatment history that includes steroids within one month prior to screening, or any other therapy that in the judgment of the investigator potentially interferes with the study objectives (in case of an insufficient washout period);
- •\- body weight \< 50 kg.
- •\- subject is pregnant or breast feeding;
- •\- current substance abuse, including alcohol and drugs;
- •\- positive alcohol test or test for drugs of abuse at screening, with the exception of a positive test due to medicinal cannabis use;
- •\- previous deuterium administration;
- •\- participation in an investigational drug or device study within 3 months prior to screening;
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 3
Scientific evaluation of Immuno-modulatory effects of AYUSH INTERVENTIONS on normal healthy and high-risk individuals in context with COVID-19 pandemic: An open level studyCTRI/2020/06/025861Department of Ayush Uttarakhand
Completed
Phase 2
Analysis of efficacy and immunomodulatory activity of lenalidomide alone in relapse and refractory multiple myelomaplasma cell myelomaJPRN-UMIN000009927Hematology, Respiratory Medicine and Oncology,Faculty of Medicine, Saga University33
Completed
Not Applicable
Verification on the immunomodulatory effects of continuous consumption of dairy productsHealthy adultJPRN-UMIN000053187Meiji Co., Ltd140
Recruiting
Not Applicable
Characterization immuno-modulatory effects of Tecfidera: feasibility study.Tecfidera induced lymphocytopeniaNL-OMON27762ot Applicable16
Not yet recruiting
Phase 2
Immuno -Modulatory Potential of AyurRaksha Kit and Its Preventive Impact on COVID 19 In Delhi PoliceCTRI/2021/08/035745Ministry of AYUSH