RESEARCH PROJECT- RETROSPECTIVE REGISTRY STUDY TO ASSESS THE VALUE OF HIGH-EFFICACY THERAPIES AND THEIR POTENTIAL TO STRENGTHEN EMPLOYMENT PARTICIPATION IN PATIENTS WITH MULTIPLE SCLEROSIS

RESEARCH PROJECT- RETROSPECTIVE REGISTRY STUDY TO ASSESS THE VALUE OF HIGH-EFFICACY THERAPIES AND THEIR POTENTIAL TO STRENGTHEN EMPLOYMENT PARTICIPATION IN PATIENTS WITH MULTIPLE SCLEROSIS - Workforce participation among patients with MS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037904

Enrollment

5000

Registered

2025-10-02

Start date

2025-08-01

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G35

Interventions

Group 1: No DMT treatment Group 2: Moderate treatment Group 3: Escalation treatment Group 4: Hit hard and early

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Vorliegen einer klinisch gesicherten Multiplen Sklerose (MS) nach den Poser- oder McDonald-Kriterien oder Vorliegen eines klinisch isolierten Syndroms (KIS). 2. Vorliegen der schriftlichen Einverständniserklärung des Patienten. 3. Hauptwohnsitz in Deutschland.

Exclusion criteria

Exclusion criteria: 1. MS disease course cannot be determined 2. Lack of ability to provide informed consent (e.g. age below 18 years) Patients from the German MS register will be included in this research when they

Design outcomes

Primary

Measure	Time frame
Primary Objective Corresponding Variable / Endpoint: To evaluate the change in employment status of patients with RRMS in the different treatment strategy groups at year 5. Variables: Working status / Date of early retirement / Date of follow-up; Endpoint: Probability of being event-free, i.e. without a change in employment status from employed at baseline (date of initial diagnosis) to early retirement at year 5 after initial diagnosis, calculated via the Kaplan-Meier estimate. The employment status “employed” includes full and part time employment (i.e. income generating work) as well as any type of education. All other changes in employment status (e.g. unemployment, parental leave, …) do not count as an event.	—

Measure

Time frame

Primary Objective Corresponding Variable / Endpoint: To evaluate the change in employment status of patients with RRMS in the different treatment strategy groups at year 5. Variables: Working status / Date of early retirement / Date of follow-up; Endpoint: Probability of being event-free, i.e. without a change in employment status from employed at baseline (date of initial diagnosis) to early retirement at year 5 after initial diagnosis, calculated via the Kaplan-Meier estimate. The employment status “employed” includes full and part time employment (i.e. income generating work) as well as any type of education. All other changes in employment status (e.g. unemployment, parental leave, …) do not count as an event.

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Secondary

Measure	Time frame
1. To compare the time to change in employment status between the different treatment strategy groups /categories. 2. To evaluate the change in employment status of patients at year 10. 3. To evaluate the detailed change in employment status. 4. To evaluate restrictions on current occupational activities. 5. To evaluate the relapse rate (ARR). 6. To evaluate the change in disability status EDSS. 7. To evaluate the occurrence of specific symptoms that may contribute to employment loss (mobility restriction/paresis, fatigue, cognitive impairment, depression, bladder dysfunction, bowel dysfunction, visual disturbances, pain).	—

Measure

Time frame

1. To compare the time to change in employment status between the different treatment strategy groups /categories. 2. To evaluate the change in employment status of patients at year 10. 3. To evaluate the detailed change in employment status. 4. To evaluate restrictions on current occupational activities. 5. To evaluate the relapse rate (ARR). 6. To evaluate the change in disability status EDSS. 7. To evaluate the occurrence of specific symptoms that may contribute to employment loss (mobility restriction/paresis, fatigue, cognitive impairment, depression, bladder dysfunction, bowel dysfunction, visual disturbances, pain).

—

Countries

Germany

Contacts

Public ContactTabea Wiemer

Roche Pharma AG

tabea.wiemer@roche.com+491724403476

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026