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Table 1 Regular Study Procedures

From: Signatures of immune reprogramming in anti-CD52 therapy of MS: markers for risk stratification and treatment response

Baseline assessments Month 0

Month 6, 12, 18, 24, 30 and 36 after treatment initiation

• Demographic information (date of birth, gender)

 

• Determination and documentation of eligibility by the Investigator or authorized representative (according to eligibility criteria)

 

• Relevant medical history: e.g., lumbar puncture, MRI, medication history and current medications, medical conditions/surgical history, clinical episode history

 

• Physical examination and documentation of vital signs

• Physical examination and documentation of vital signs

• Adverse events and concomitant medication

• Adverse events and concomitant medication

• MSFC

• MSFC

• EDSS

• EDSS

• Collection of peripheral blood and serum for several in vitro and ex vivo assessments (8 × 9 ml EDTA blood, 2 × 9 ml serum) as part of the routine blood assessments (including complete blood count, serum creatinine levels, tests of thyroid function)

• Collection of peripheral blood and serum for several in vitro and ex vivo assessments (8 × 9 ml EDTA blood, 2 × 9 ml serum) as part of the routine blood assessments (including complete blood count, serum creatinine levels, tests of thyroid function)