Safety and Effectiveness of Ocrelizumab under Real World Conditions: a Non-Interventional Post Authorization Safety Study in Patients Diagnosed with Relapsing or Primary Progressive Multiple Sclerosis (CONFIDENCE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47489
• EU PAS number:
  EUPAS22951
• Study ID:
  47489
• Official title and acronym:
  Safety and Effectiveness of Ocrelizumab under Real World Conditions: a Non-Interventional Post Authorization Safety Study in Patients Diagnosed with Relapsing or Primary Progressive Multiple Sclerosis (CONFIDENCE)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  CONFIDENCE is a prospective, multicenter, non-interventional, long-term study collecting primary data in RMS and PPMS patients newly treated during their course of MS therapy with ocrelizumab, or selected MS DMTs (i.e., alemtuzumab, cladribine, dimethyl fumarate, fingolimod, natalizumab, or teriflunomide), in routine clinical practice. To provide robust evidence on the safety and effectiveness profile of ocrelizumab, data from 3000 MS patients treated with ocrelizumab and 767 MS patients treated with other selected MS DMTs from approx. 185 neurological centers and practices in Germany are planned to be included.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Actual: 02/02/2018

Study start date

Planned: 30/03/2018

Actual: 03/04/2018

Date of final study report

Planned: 30/11/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Hoffmann La Roche

Study protocol

Initial protocol

ML39632_NI-PASS Confidence fv1.0_2018-01-26_Redacted

Updated protocol

ML39632_CONFIDENCE_Protocol_V6.0_Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

ML39632