Longitudinal Next Generation Sequencing (NGS) in Patients with Relapsing-Remitting Multiple Sclerosis (Systematic investigation of genomic activity in patients with RR-MS)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00006351

Enrollment

Registered

2014-10-27

Start date

2014-11-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

G35.1

Interventions

Group 1: Systematic investigation of genomic activity (Next Generation Sequencing (NGS)) at three diffrent points: Under original immunomodulatory therapy, after washout of the initial treatment (afte

Eligibility

Sex/Gender

Female

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: - Female patients with a diagnosis of relapsing-remitting multiple sclerosis (McDonald criteria 2010) - Planned conversion of MS - Therapy - Patients with an age between 18 and 50 - No MS - relapse in the last 4 weeks - Written documented consent

Exclusion criteria

Exclusion criteria: - Signs of opportunistic infection - Signs of a tumor disease - (Pre-) treatment with immunsuppressive drugs (azathioprine, methotrexate, mitoxantrone, cyclophosphamide) - Pregnancy - Severe Depression (CES-D in Screnning> 30) - Alcohol or drug abuse

Design outcomes

Primary

Measure	Time frame
Systematic investigation of genomic activity in 15 genomic loci (which have shown some association with MS) with next generation Sequencing (NGS) in patient with RR - MS after changing of the immunmodulatory therapy (TxA (original immunmodulatory therapy) vs. no treatment (8 - 10 weeks wash out) vs. TxB (3 month after change of the immunmodulatory therapy)	—

Secondary

Measure	Time frame
• changes in gene expression in the whole exome (NGS initially, after 3 months, after 6 months) • Progression on MRI (T1/T2LL, new gadolinium lesions) (initial, after 3 months, after 6 months) • progression of clinical parameters (EDSS) (initial, after 3 months, after 6 months) • Progression in neuropsychological functions (initial, after 6 months): - SDMT (Symbol Digit Modalities Test = attention and concentration testing) - MSFC (multiple-sclerosis-functional-composite-scale performance scale = to assess the severity of the disability) - QoL (SF-36) (quality of life = quality of life questionnaire)	—

Measure

Time frame

• changes in gene expression in the whole exome (NGS initially, after 3 months, after 6 months) • Progression on MRI (T1/T2LL, new gadolinium lesions) (initial, after 3 months, after 6 months) • progression of clinical parameters (EDSS) (initial, after 3 months, after 6 months) • Progression in neuropsychological functions (initial, after 6 months): - SDMT (Symbol Digit Modalities Test = attention and concentration testing) - MSFC (multiple-sclerosis-functional-composite-scale performance scale = to assess the severity of the disability) - QoL (SF-36) (quality of life = quality of life questionnaire)

—

Countries

Germany

Contacts

Public ContactWolfgang Köhler

Fachkrankenhaus Hubertusburg Klinik für Neurologie/Neurologische Intensivmedizin

wolfgang.koehler@kh-hubertusburg.de03436462356

Outcome results

None listed

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