Lympho-TEC: Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera
Study Details
Study Description
Brief Summary
The primary objective of the study is to describe absolute lymphocyte count (ALC) reconstitution after Dimethyl fumarate (DMF) discontinuation because of lymphopenia, in Relapsing-Remitting Multiple Sclerosis (RRMS) participants.
The secondary objectives of the study are characterization of lymphopenia; characterization of lymphopenia having led to DMF discontinuation treatment; description of the evolution of ALC during DMF treatment; description of discontinuation of DMF treatment; exploration of clinical outcomes in participants with lymphopenia on DMF and/or after DMF discontinuation due to lymphopenia; description of vigilance and participant management overall and in participants with lymphopenia who continued DMF treatment; incidence's assessment of opportunistic or serious infections; investigation of the potential impact of baseline demographic and disease characteristics in risk of developing lymphopenia while on DMF; investigation of the potential impact of baseline demographics on the kinetics of ALC reconstitution upon discontinuation of DMF; investigation of the changes of lymphocyte subtypes in participants on DMF if available.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The study will select participants initiating treatment from 01 Jan 2016 to 15 Dec 2020.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| All Participants RRMS participants treated with DMF will be identified in the EDMUS database for Observatoire Français de la Sclérose en Plaques (OFSEP) sites. |
Drug: Dimethyl fumarate
Administered as specified in the treatment arm.
|
Outcome Measures
Primary Outcome Measures
- Time to Absolute Lymphocyte Count (ALC) Reconstitution After Dimethyl Fumarate (DMF) Discontinuation [Up to end of study (121 days)]
Secondary Outcome Measures
- Time From DMF Initiation to Lymphopenia Initiation Assessed in Participants With and Without DMF Discontinuation [Up to end of study (121 days)]
- Time From DMF Initiation to Lymphopenia Assessed at Time of DMF Discontinuation [Up to end of study (121 days)]
This outcome measure will be assessed in subgroup of participants who discontinued DMF because of lymphopenia.
- Percent Change in ALC Over Time From DMF Initiation to DMF Discontinuation or End of Study [Up to end of study (121 days)]
- Time From DMF Initiation to DMF Discontinuation [Up to end of study (121 days)]
- Percentage of Participants with Discontinuation of DMF Treatment [Up to end of study (121 days)]
- Percentage of Participants on DMF and/or After Discontinuation Reflecting Relapses and/or an Expanded Disability Status Scale (EDSS) Progression [Up to end of study (121 days)]
EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in multiple sclerosis (MS). Scores range from 0.0 (normal) to 10.0 (death due to MS).
- Percentage of Participants with Serious Adverse Events (SAEs) [Up to end of study (121 days)]
An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event.
- Percentage of Participants With Opportunistic or Serious Infections [Up to end of study (121 days)]
- Time to Occurrence of Lymphopenia During DMF Treatment Assessed in Association Between Demographic and Clinical Characteristics [Up to end of study (121 days)]
Association between baseline demographic and clinical characteristics like age, gender, diabetes, smoking habits, baseline ALC, time since MS diagnosis, number of relapses in prior year, baseline EDSS, duration of treatment, any prior DMT, duration of lymphopenia, and grade of lymphopenia will be assessed in this outcome measure.
- Time to Lymphocyte Reconstitution After DMF Discontinuation Assessed in Association Between Demographic and Clinical Characteristics [Up to end of study (121 days)]
Association between baseline demographic and clinical characteristics like age, gender, diabetes, smoking habits, baseline ALC, time since MS diagnosis, number of relapses in prior year, baseline EDSS, duration of treatment, any prior DMT, duration of lymphopenia, and grade of lymphopenia will be assessed in this outcome measure.
- Percent Change from Baseline in Absolute CD4+ Count [Up to end of study (121 days)]
- Percent Change from Baseline in Absolute CD8+ Count [Up to end of study (121 days)]
- Percent Change from Baseline in Absolute CD4+/CD8+ Ratio [Up to end of study (121 days)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinical diagnosis of RRMS at DMF initiation
-
Minimum of 3 months of continuous treatment with DMF*
-
Initiation of DMF between January 1st, 2016 and December 15th, 2020
-
Minimum of 2 ALC assessments:
-
1 ALC at DMF initiation (or within 6 months before DMF initiation); or under DMF treatment before lymphopenia
-
1 ALC before the database extraction (15/06/2021).
- to avoid the early DMF discontinuations for reasons other than lymphopenia.
Exclusion Criteria:
- Participants will be excluded from the study entry if they express their opposition to collect the data upon the information.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Amiens | France | ||
| 2 | Research Site | Besançon | France | ||
| 3 | Research Site | Bordeaux | France | ||
| 4 | Research Site | Brest | France | ||
| 5 | Research Site | Caen | France | ||
| 6 | Research Site | Clermont-Ferrand | France | ||
| 7 | Research Site | Dijon | France | ||
| 8 | Research Site | Grenoble | France | ||
| 9 | Research Site | Lille | France | ||
| 10 | Research Site | Limoges | France | ||
| 11 | Research Site | Lyon | France | ||
| 12 | Research Site | Marseille | France | ||
| 13 | Research Site | Montpellier | France | ||
| 14 | Research Site | Nancy | France | ||
| 15 | Research Site | Nantes | France | ||
| 16 | Research Site | Nice | France | ||
| 17 | Research Site | Nîmes | France | ||
| 18 | Research Site | Poitiers | France | ||
| 19 | Research Site | Rennes | France | ||
| 20 | Research Site | Rouen | France | ||
| 21 | Research Site | Saint-Etienne | France | ||
| 22 | Research Site | Strasbourg | France | ||
| 23 | Research Site | Toulouse | France | ||
| 24 | Research Site | Tours | France | ||
| 25 | Research Site | Île-de-France - Bicêtre | France | ||
| 26 | Research Site | Île-de-France - Créteil | France | ||
| 27 | Research Site | Île-de-France - Poissy St-Germain | France | ||
| 28 | Research Site | Île-de-France - Pontoise | France | ||
| 29 | Research Site | Île-de-France - Rothschild | France | ||
| 30 | Research Site | Île-de-France - Saint-Antoine | France | ||
| 31 | Research Site | Île-de-France - Saint-Denis | France | ||
| 32 | Research Site | Île-de-France - Salpêtrière | France |
Sponsors and Collaborators
- Biogen
Investigators
- Study Director: Medical Director, Biogen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FR-BGT-11758