|  |  | 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 | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Patient characteristics (age and sex) | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
MS anamnesis | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
- Diagnosis | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
- Date of first diagnosis (RRMS) | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
- Number of relapses in the last year and the year before | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
- Comorbidities including fatigue and depression | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
- Previous MS basis therapy | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Relapses during observation time | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
- Number | x | Â | x | x | x | x | x | x | x | x | x | x | x | x |
- Number of relapses treated with cortisone | x | Â | x | x | x | x | x | x | x | x | x | x | x | x |
EDSS (Expanded Disability Status Scale) | x | Â | Â | Â | x | Â | Â | x | Â | Â | x | Â | Â | x |
SDMT (Symbol Digit Modality Test) | x | Â | Â | Â | Â | Â | Â | x | Â | Â | Â | Â | Â | x |
PRIM US (Patient-Reported Indices for MS) | x | Â | Â | Â | Â | Â | Â | x | Â | Â | Â | Â | Â | x |
EuroQol (ED-SD) | x | Â | Â | Â | Â | Â | Â | x | Â | Â | Â | Â | Â | x |
Responding to treatment/clinical evaluation | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
CGI (Clinical Global Impressions Scale): | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
- Details provided by the physician | x | Â | Â | Â | Â | Â | Â | x | Â | Â | Â | Â | Â | x |
- Details provided by the patient | x | Â | Â | Â | Â | Â | Â | x | Â | Â | Â | Â | Â | x |
Economic parameters | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
WPAI (Work productivity and Activity Impairment Questionnaire) | x | Â | Â | Â | Â | Â | Â | x | Â | Â | Â | Â | Â | x |
Examinations before and after therapy with Lemtrada® |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Pre-existing illnesses | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Bodily examination | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Total and differential blood count | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
Serum creatine level | Â | x | x | x | x | x | x | x | x | x | x | x | x | x |
Urine status | Â | x | x | x | x | x | x | x | x | x | x | x | x | x |
Thyroid gland function (TSH) | x | x | Â | Â | x | Â | Â | x | Â | Â | x | Â | Â | x |
Vaccination status | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Infections | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
HIV infection | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Test for tuberculosis | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Test for hepatits B and C | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Tests for varicella-zoster virus | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Test for JC virus | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Contraception/exclusion of an existing pregnancy | x | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Adverse events since therapy start | Â | Â | x | x | x | x | x | x | x | x | x | x | x | x |
MRI (new T2 or Gd(+)-lesions) | x | Â | if MRT examinations are performed routinely |