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Table 1 Study schedule

From: Rationale, design, and methods of a non-interventional study to establish safety, effectiveness, quality of life, cognition, health-related and work capacity data on Alemtuzumab in multiple sclerosis patients in Germany (TREAT-MS)

    Control examination: month after start of treatment
    1 2 3 4 5 6 7 8 9 10 11 12
    13 14 15 16 17 18 19 20 21 22 23 24
   Treatment 25 26 27 28 29 30 31 32 33 34 353 36
   1st infusion 37 38 39 40 41 42 43 44 45 46 47 48
  baseline 2nd infusion 49 50 51 52 53 54 55 56 57 58 59 60
Singed declaration of informed consent x              
Patient characteristics (age and sex) x              
MS anamnesis               
- Diagnosis x              
- Date of first diagnosis (RRMS) x              
- Number of relapses in the last year and the year before x              
- Comorbidities including fatigue and depression x              
- Previous MS basis therapy x              
Relapses during observation time               
- Number x   x x x x x x x x x x x x
- Number of relapses treated with cortisone x   x x x x x x x x x x x x
EDSS (Expanded Disability Status Scale) x     x    x    x    x
SDMT (Symbol Digit Modality Test) x        x       x
PRIM US (Patient-Reported Indices for MS) x        x       x
EuroQol (ED-SD) x        x       x
Responding to treatment/clinical evaluation               
CGI (Clinical Global Impressions Scale):               
- Details provided by the physician x        x       x
- Details provided by the patient x        x       x
Economic parameters               
WPAI (Work productivity and Activity Impairment Questionnaire) x        x       x
Examinations before and after therapy with Lemtrada®               
Pre-existing illnesses x              
Bodily examination x              
Total and differential blood count x x x x x x x x x x x x x x
Serum creatine level   x x x x x x x x x x x x x
Urine status   x x x x x x x x x x x x x
Thyroid gland function (TSH) x x    x    x    x    x
Vaccination status x              
Infections x              
HIV infection x              
Test for tuberculosis x              
Test for hepatits B and C x              
Tests for varicella-zoster virus x              
Test for JC virus x              
Contraception/exclusion of an existing pregnancy x   x            
Adverse events since therapy start    x x x x x x x x x x x x
MRI (new T2 or Gd(+)-lesions) x   if MRT examinations are performed routinely
  1. Baseline at least 6 weeks prior to first alemtuzumab injection, if vaccinations need to be made