Multiple SclerosisLympho-TECNCT04756687
Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera
An observational study of Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 32 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Dimethyl fumarate
- How many people
- 1,507 participants
- Where
- 32 sitesFrance
- Study dates
- 10 Mar 2021to 15 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All RRMS participants treated with DMF who fulfil the inclusion criteria are eligible to participate in the study.
Who may be able to join
- 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
- 1 ALC before the database extraction (15/06/2021).
- to avoid the early DMF discontinuations for reasons other than lymphopenia.
Who cannot join
- Participants will be excluded from the study entry if they express their opposition to collect the data upon the information.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
France32 sites
Research Site
Amiens
Research Site
Besançon
Research Site
Bordeaux
Research Site
Brest
Research Site
Caen
Research Site
Clermont-Ferrand
Research Site
Dijon
Research Site
Grenoble
Research Site
Île-de-France - Bicêtre
Research Site
Île-de-France - Créteil
Research Site
Île-de-France - Poissy St-Germain
Research Site
Île-de-France - Pontoise
Research Site
Île-de-France - Rothschild
Research Site
Île-de-France - Saint-Antoine
Research Site
Île-de-France - Saint-Denis
Research Site
Île-de-France - Salpêtrière
Research Site
Lille
Research Site
Limoges
Research Site
Lyon
Research Site
Marseille
Research Site
Montpellier
Research Site
Nancy
Research Site
Nantes
Research Site
Nice
Research Site
Nîmes
Research Site
Poitiers
Research Site
Rennes
Research Site
Rouen
Research Site
Saint-Etienne
Research Site
Strasbourg
Research Site
Toulouse
Research Site
Tours
About this study
Official title: A Retrospective Analysis in Real World on Lymphocyte Reconstitution After Lymphopenia in Patients Treated by Tecfidera and Description of Management Strategies in France
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.
Read the detailed description
The study will select participants initiating treatment from 01 Jan 2016 to 15 Dec 2020.
- Being tested
- Dimethyl fumarate
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimethyl fumarateDrug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | RRMS participants treated with DMF will be identified in the Observatoire Français de la Sclérose en Plaques (OFSEP) database for OFSEP sites. Receives: Drug: Dimethyl fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ALC Reconstitution After DMF Discontinuation
Measured: Up to end of study (121 days)
Secondary outcomes (13)
Time From DMF Initiation to Lymphopenia Initiation Assessed in Participants With and Without DMF Discontinuation
Measured: Up to end of study (121 days)
Time From DMF Initiation to Lymphopenia Assessed at Time of DMF Discontinuation
This outcome measure will be assessed in subgroup of participants who discontinued DMF in the lymphopenic population.
Measured: Up to end of study (121 days)
Percent Change in ALC Over Time From DMF Initiation to DMF Discontinuation or End of Study
Measured: Up to end of study (121 days)
Time From DMF Initiation to DMF Discontinuation
Measured: Up to end of study (121 days)
Percentage of Participants with Discontinuation of DMF Treatment
Measured: Up to end of study (121 days)
Time to DMF Discontinuation to the First Relapses and/or an EDSS Progression
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).
Measured: Up to end of study (121 days)
Percentage of Participants With Serious or Opportunistic Infections in Overall and According to DMF On-going or not and in Lymphopenic Population
Measured: Up to end of study (121 days)
Percentage of Participants With Serious and Opportunistic Infections in Overall and in Lymphopenic Population
Measured: Up to end of study (121 days)
Time to Occurrence of Lymphopenia During DMF Treatment Assessed in Association Between Demographic and Clinical Characteristics
Association between baseline demographic and clinical characteristics like age at DMF initiation, gender, diabetes, smoking habits, first ALC value close to DMF initiation, disease duration at DMF initiation, number of relapses in prior year, baseline EDSS, and any prior DMT will be assessed in this outcome measure.
Measured: Up to end of study (121 days)
Time to Lymphocyte Reconstitution After DMF Discontinuation Assessed in Association Between Demographic and Clinical Characteristics
Association between baseline demographic and clinical characteristics like age at DMF discontinuation, gender, diabetes, smoking habits, last ALC during DMF, disease duration at DMF discontinuation, number of relapses in prior year before DMF initiation, EDSS at DMF discontinuation, DMF duration (overall, up to lymphopenia, after lymphopenia), any prior DMT, and grade of lymphopenia will be assessed in this outcome measure.
Measured: Up to end of study (121 days)
Percent Change from Baseline in Absolute CD4+ Count
Measured: Up to end of study (121 days)
Percent Change from Baseline in Absolute CD8+ Count
Measured: Up to end of study (121 days)
Percent Change from Baseline in Absolute CD4+/CD8+ Ratio
Measured: Up to end of study (121 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start10 Mar 2021
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756687
- Sponsor's protocol ID
- FR-BGT-11758
- Acronym
- Lympho-TEC
- Status last verified
- Oct 2023
- First submitted
- 12 Feb 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Publications
de Seze J, Labauge P, Liblau R, Martinez M, Moreau T, Suchet L, Vermersch P, Vukusic S, Mathey G, Michel L, Ciron J, Ruet A, Maillart E, Zephir H, Papeix C, Defer G, Cohen M, Laplaud DA, Berger E, Clavelou P, Thouvenot E, Heinzlef O, Pelletier J, Giannesini C, Casez O, Bourre B, Wahab A, Magy L, Camdessanche JP, Doghri I, Labeyrie C, Hankiewicz K, Neau JP, Pottier C, Dobay P, Li H, Levin S, Gros M, Ruiz M, Rollot F. LymphoTEC: a Retrospective Real-World Study on Lymphocyte Reconstitution After Lymphopenia in Patients with Multiple Sclerosis Treated with Dimethyl Fumarate in France. Adv Ther. 2025 Apr;42(4):1760-1782. doi: 10.1007/s12325-024-03092-5. Epub 2025 Feb 19.
PubMed 39969782
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis in Real World on Lymphocyte Reconstitution After Lymphopenia in Patients Treated by Tecfidera and Description of Management Strategies in France
- ClinicalTrials.gov ID
- NCT04756687
- Acronym / sponsor ID
- Lympho-TEC / FR-BGT-11758
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,507 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Drug: Dimethyl fumarateRRMS participants treated with DMF will be identified in the Observatoire Français de la Sclérose en Plaques (OFSEP) database for OFSEP sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All RRMS participants treated with DMF who fulfil the inclusion criteria are eligible to participate in the study.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (1 listed)
- Participants will be excluded from the study entry if they express their opposition to collect the data upon the information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimethyl fumarateAdministered as specified in the treatment arm. | Drug | All Participants |
Primary outcome
Time to ALC Reconstitution After DMF Discontinuation
Time frame: Up to end of study (121 days)
13 secondary outcomes
Time From DMF Initiation to Lymphopenia Initiation Assessed in Participants With and Without DMF Discontinuation
Time frame: Up to end of study (121 days)
Time From DMF Initiation to Lymphopenia Assessed at Time of DMF Discontinuation
Time frame: Up to end of study (121 days)
Percent Change in ALC Over Time From DMF Initiation to DMF Discontinuation or End of Study
Time frame: Up to end of study (121 days)
Time From DMF Initiation to DMF Discontinuation
Time frame: Up to end of study (121 days)
Percentage of Participants with Discontinuation of DMF Treatment
Time frame: Up to end of study (121 days)
Time to DMF Discontinuation to the First Relapses and/or an EDSS Progression
Time frame: Up to end of study (121 days)
Percentage of Participants With Serious or Opportunistic Infections in Overall and According to DMF On-going or not and in Lymphopenic Population
Time frame: Up to end of study (121 days)
Percentage of Participants With Serious and Opportunistic Infections in Overall and in Lymphopenic Population
Time frame: Up to end of study (121 days)
Time to Occurrence of Lymphopenia During DMF Treatment Assessed in Association Between Demographic and Clinical Characteristics
Time frame: Up to end of study (121 days)
Time to Lymphocyte Reconstitution After DMF Discontinuation Assessed in Association Between Demographic and Clinical Characteristics
Time frame: Up to end of study (121 days)
Percent Change from Baseline in Absolute CD4+ Count
Time frame: Up to end of study (121 days)
Percent Change from Baseline in Absolute CD8+ Count
Time frame: Up to end of study (121 days)
Percent Change from Baseline in Absolute CD4+/CD8+ Ratio
Time frame: Up to end of study (121 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 39969782de Seze J, Labauge P, Liblau R, Martinez M, Moreau T, Suchet L, Vermersch P, Vukusic S, Mathey G, Michel L, Ciron J, Ruet A, Maillart E, Zephir H, Papeix C, Defer G, Cohen M, Laplaud DA, Berger E, Clavelou P, Thouvenot E, Heinzlef O, Pelletier J, Giannesini C, Casez O, Bourre B, Wahab A, Magy L, Camdessanche JP, Doghri I, Labeyrie C, Hankiewicz K, Neau JP, Pottier C, Dobay P, Li H, Levin S, Gros M, Ruiz M, Rollot F. LymphoTEC: a Retrospective Real-World Study on Lymphocyte Reconstitution After Lymphopenia in Patients with Multiple Sclerosis Treated with Dimethyl Fumarate in France. Adv Ther. 2025 Apr;42(4):1760-1782. doi: 10.1007/s12325-024-03092-5. Epub 2025 Feb 19.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 32 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to ALC Reconstitution After DMF Discontinuation (time frame: Up to end of study (121 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04756687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.