Trials / Completed
CompletedNCT04756687
Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera
A Retrospective Analysis in Real World on Lymphocyte Reconstitution After Lymphopenia in Patients Treated by Tecfidera and Description of Management Strategies in France
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,507 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to describe absolute lymphocyte count (ALC) reconstitution after Dimethyl fumarate (DMF) discontinuation, in Relapsing-Remitting Multiple Sclerosis (RRMS) participants with lymphopenia. The secondary objectives of the study are characterization of lymphopenia in overall population; characterization of lymphopenia in participant with DMF discontinuation ; description of the evolution of ALC during DMF treatment; description of the time to reach a discontinuation of DMF treatment; exploration of the time to reach clinical outcomes (Expanded Disability Status Scale \[EDSS\] and relapse) according to lymphopenia; description of the event rate of the serious or opportunistic infections in overall population from DMF initiation and according to DMF discontinuation and lymphopenia; description of the event rate of serious and opportunistic infections in overall population from DMF initiation and according to lymphopenia; estimation of the associations between the baseline demographic and clinical characteristics and the risk to reach a lymphopenia; estimation of the associations between the baseline demographics and clinical characteristics and the risk to reach an ALC reconstitution after DMF discontinuation in participants with lymphopenia; and investigation of the changes of absolute cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) count in overall population on DMF if available.
Detailed description
The study will select participants initiating treatment from 01 Jan 2016 to 15 Dec 2020.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dimethyl fumarate | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2021-03-10
- Primary completion
- 2021-06-15
- Completion
- 2021-06-15
- First posted
- 2021-02-16
- Last updated
- 2023-10-23
Locations
32 sites across 1 country: France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04756687. Inclusion in this directory is not an endorsement.