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Table 2 Data collection overview

From: Design of a non-interventional post-marketing study to assess the long-term safety and effectiveness of ocrelizumab in German real world multiple sclerosis cohorts – the CONFIDENCE study protocol

Data to be collected

Study Enrollment (Screening)

Baseline (Study Entry)

Data Collection (approximately every ~ 6 months)

Study Completion/ Study Withdrawal

Patient demographics

X

   

Informed consent

X

   

Inclusion/exclusion criteria

X

   

Vital signs and measurementsa

 

X

X

X

Pregnancy status (patient-reported)

 

X

X

X

Pregnancies

 

whenever they occur

Laboratory test resultsb

 

X

X

X

John Cunningham Virus (JCV) antibody status / index

 

X

  

MS disease historyc

 

X

  

MS treatment historyd

 

X

  

Medical history and comorbidities

 

X

  

Clinically significant medical and surgical history (including previous malignancies and precancerous lesions)

 

X

  

Malignancy risk factor informatione

 

X

  

Cancer screeningf

 

X

X

X

MS symptomsg

 

X

X

X

Current MS DMT administration informationh

 

X

X

X

Patient Reported Outcomes (PROs): Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4, Multiple Sclerosis Impact Scale (MSIS)-29v2, adapted Clinical Global Impression (CGI), Symbol Digit Modality Test (SDMT)

 

X

X

X

Pharmacoeconomic outcomes: Work Productivity and Activity Impairment Questionnaire: MS (WPAI:MS)

 

X

X

X

Premature termination incl. Reasons for study withdrawal

   

X

Continuation of therapy or reasons for treatment discontinuation

  

X

X

Prior and concomitant medications other than MS medication (up to 3 months prior to study entry)

 

X

X

X

Any malignanciesi

 

whenever they occur

All serious and non-serious AEs incl. Non-melanoma skin cancer (NMSCs) and information on reasons for death

 

whenever they occur

Death information

  

X

X

  1. a Height, weight, blood pressure, heart rate and temperature
  2. b Blood cell count, immunoglobulins, liver enzymes, renal status, clinical chemistry, flow cytometry. Viral serology (only at baseline)
  3. c Including MS date of diagnosis, type of MS, duration of MS, MS disease symptom history, relapse history, EDSS (or proxy) and MRI results (if available)
  4. d Prior use and duration of therapies for MS and prior use and duration of immunomodulatory, immunosuppressive, and anti-neoplastic agents (if any)
  5. e Including tobacco use history, alcohol use history, family disease history, genetic testing such as BRCA1 and 2, personal history of malignancy, or other risk factors including reproductive history (women and undifferentiated only); the selection of these risk factors is based on the VERISMO study (for further details on VERISMO, see Discussion)
  6. f Including gynecological consultation, breast check, dermatological check, or other malignancy/cancer screening tests and procedures (e.g., mammography, Pap test, colonoscopy, laboratory malignancy markers)
  7. g Including MS relapse during treatment period, MS type changes, date of last administration of Ocrelizumab (if applicable), MS DMT changes and rationale, most recent EDSS score since last encounter (if available), most recent MRI results since last encounter (if available)
  8. h Dates of administration (start, stop, and restart dates), dose, dosing frequency, reason for discontinuation (if applicable)
  9. i Medical records regarding in-depth malignancy information will be solicited from the patient’s oncologist or pathologist (only collected if a malignancy is identified)