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Table 2 Schedule of regular study visits

From: Assessment of immune functions and MRI disease activity in relapsing-remitting multiple sclerosis patients switching from natalizumab to fingolimod (ToFingo-Successor)

Study Phase Screening Wash-out ← Treatment → Follow up
Visit* 1 2 3 4 5 6 7 8 9 10** 11 12
Study Week −4 – 0 0 4 8 12 16 20 24 28 32 36 40
Obtain informed consent X            
Background/Demography X            
Inclusion/exclusion criteria X X           
Medical History X            
MS history/MS treatment X            
Prior/Concomitant medication X X X X X X X X X X X X
Pregnancy test (serum) X            
Pregnancy test (urine dipstick)   X X X X X X X X X X X
Physical examination X X X X X X X X X X   
MSFC X6 X         X   
Neurological examination (including EDSS) X X X X X X X X X X   
Vital signs X X X X X X X X X X X X
Clinical laboratory (blood chemistry/hematology) X X X X X X X X X X X X
PBMC isolation for evaluation of immunological parameters   X X X X X X X X X X X
CSF sampling1   X         X   
JCV sample X          X   
Ophtalmologic examination2 X       X      
Last natalizumab dose   X           
ECG X            
First dose monitoring (=FDM)3     X         
Dispensing of patient’s diary     X         
Collecting of patient’s diary           X   
Study drug prescription     X X    X     
MRI (including DTI)4,5   X   X X X   X   X   
MS relapse X X X X X X X X X X X X
Adverse events/SAEs   X X X X X X X X X X X
  1. *At each visit the patient must be reminded of the importance of remaining vigilant for infections, performing regular skin selfassessments, and in women of child bearing age, practicing contraception per protocol
  2. ** EOT/ Assessments also for PPW (Premature Patient Withdrawal)
  3. 1In several patients (estimated number: 8–10), CSF specimen will be obtained under long-term natalizumab (i.e. baseline) and
  4. after 24 weeks of fingolimod therapy and will immediately be analyzed by flow cytometry
  5. 2Patients with a history of uveitis or with diabetes mellitus must perform an ophthalmologic examination prior to the treatment start of fingolimod. Ophthalmologic examination includes eye history and procedures necessary to assess macular edema (e.g. ophthalmoscopy). OCT is only done to confirm macular edema
  6. 3Patients will be monitored on-site in the clinic for at least six hours after dose administration at First Dose Monitoring (FDM) visits (see Appendix 3 for details). Pulse and blood pressure will be obtained three times for pre-dose assessment. The monitoring includes a 12-lead ECG prior and 6 hours after the first dose, as well as blood pressure and heart rate measurement every hour
  7. after the first dose
  8. 4Window for MRI is +/− 7 days
  9. 5If a patient discontinues study treatment early due to relapse and last MRI was > 10 days from relapse confirmation, an MRI should be performed, if possible, prior to initiation of corticosteroid treatment
  10. 6MSFC at Screening (V1) should be taken as rehearsal