CLADQoL: CLADribine tablets –evaluation of Quality of Life

CLADQoL: CLADribine tablets –evaluation of Quality of Life - CLADQoL

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00013934

Enrollment

385

Registered

2018-02-28

Start date

2018-02-28

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: Patients suffering from multiple sclerosis and already being treated with Cladribine will be asked whether they would like to participate in this observational trial. If they confirm their co

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: - Patients (male or female) aged 18-55 years - All patients eligible to receive Cladribine tablets as per registered label - Patients using Cladribine tablets for the first time - Signed informed consent

Exclusion criteria

Exclusion criteria: - Existing pregnancy or lactation - Contraindications to use of Cladribine tablets according to the Summary of Product Characteristics

Design outcomes

Primary

Measure	Time frame
To assess the health related quality of life through the MSQOL-54 scale in relapsing multiple sclerosis patients treated with Cladribine Tablets for 24 months The MSQOL-54 is filled in at the beginning of the study (baseline), after 12, 24, 36 and 48 months.	—

Secondary

Measure	Time frame
To assess cognitive function in patients treated with Cladribine tablets for 24 months. The cognitive function is determined using the SDMT (Symbol Digital Modalities Test) at the beginning of the study (baseline) and after 12, 24, 36 and 48 months. To assess treatment satisfaction through the TSQM questionnaire in relapsing multiple sclerosis patients. The questionnaire will be completed at baseline and after 6, 18 and 48 months. To assess relapse rate, fatigue and disability progression under medication with Cladribine Tablets. The annual relapse rate is a number and reflects the number of relapses in a year. In this study it is collected and compared at baseline and at 24 months. Fatigue is determined using the FSMC (Fatigue Scale for Motor and Cognition) at the beginning of the study (baseline) and after 12, 24, 36 and 48 months. Disability progression is determined by various tests: Expanded Disability Status Scale (EDSS), 9-hole peg test (9-HPT), and 25-foot walk (T25-FW). These are routine tests, which are usually done once a year. Employment status; To evaluate maintenance of treatment effect between 2 and 4 years.	—

Measure

Time frame

To assess cognitive function in patients treated with Cladribine tablets for 24 months. The cognitive function is determined using the SDMT (Symbol Digital Modalities Test) at the beginning of the study (baseline) and after 12, 24, 36 and 48 months. To assess treatment satisfaction through the TSQM questionnaire in relapsing multiple sclerosis patients. The questionnaire will be completed at baseline and after 6, 18 and 48 months. To assess relapse rate, fatigue and disability progression under medication with Cladribine Tablets. The annual relapse rate is a number and reflects the number of relapses in a year. In this study it is collected and compared at baseline and at 24 months. Fatigue is determined using the FSMC (Fatigue Scale for Motor and Cognition) at the beginning of the study (baseline) and after 12, 24, 36 and 48 months. Disability progression is determined by various tests: Expanded Disability Status Scale (EDSS), 9-hole peg test (9-HPT), and 25-foot walk (T25-FW). These are routine tests, which are usually done once a year. Employment status; To evaluate maintenance of treatment effect between 2 and 4 years.

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Countries

Austria, Germany

Contacts

Public ContactAnita Posevitz-Fejfár

Merck Healthcare Germany GmbH

anita.posevitz-fejfar@merckgroup.com06151-720

Outcome results

None listed

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