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

Conditions: G35.1

Registration Number: DRKS00006351

Lead Sponsor: ovartis GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 10

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

- 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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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