A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA

Study identification

• EU PAS number:
  EUPAS28992
• Study ID:
  36709
• Official title and acronym:
  A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA
• DARWIN EU® study:
  No
• Study countries:
  Belgium
• Study description:
  The primary objective for this study is long-term safety (incidence and pattern of serious adverse events) in subjects receiving natalizumab.The secondary objective is to evaluate the long-term efficacy of natalizumab in delaying the progression of disability, reducing the frequency of relapses, decreasing the disease activity observed by magnetic resonance imaging (MRI), and the evaluation of the quality of life and cognitive function in patients on treatment with natalizumab for more than 8 years.
• Study status:
  Finalised

Research institutions and networks

Institutions

Biogen

Multiple centres: 4 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 08/10/2014

Study start date

Actual: 10/12/2014

Date of final study report

Actual: 05/03/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

BEL-TYS-14-106752014-003669-97 https://www.clinicaltrialsregister.eu/ctr-search/search?query=bel-tys-14-10675