A safety study for patients with Relapsing Forms of Multiple Sclerosis who participated STRATA.

• Register: EUCTR
• Last refreshed on: 30 April 2018
• Main ID: EUCTR2014-003669-97-BE
• Date of registration: 02/09/2014
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec
• Public title: A safety study for patients with Relapsing Forms of Multiple Sclerosis who participated STRATA.
• Scientific title: A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA.
• Date of first enrolment: 27/10/2014
• Target sample size: 10
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003669-97
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium

Contacts

• Name: Sabrina Wijnen
• Affiliation: Clinitude (Division Newx)

• Name: Sabrina Wijnen
• Affiliation: Clinitude (Division Newx)

Key inclusion & exclusion criteria

Inclusion criteria:
1. Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and any authorizations required by local law in accordance with national and local subject privacy regulations.
2. Has participated in the STRATA Study, have stable disease and do not meet reimbursement criteria for natalizumab (Tysabri®) in Belgium, upon termination of the STRATA Study.
3. Are =18 years old.
4. Subjects of child bearing potential must practice effective contraception during the study and be able to continue contraception for 3 months after their last infusion.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion criteria:
1. Patients participating in STRATA who were in line with current Belgian reimbursement criteria when they started in one of the feeder studies (Affirm or Sentinel).
2. Subjects with any significant change in clinical status, that in the opinion of the Investigator, would make them unsuitable to participate in this study. The investigator must review the subject’s medical fitness for participation and consider any diseases that would preclude treatment.
3. Subjects that are unwilling or unable to comply with study requirements, or are deemed unsuitable for study participation as determined by the Investigator.
4. Female Subjects who are considering becoming pregnant while in the study.
5. Female Subjects of childbearing potential and are not using the appropriate contraception as determined by the Investigator.
6. Female subjects who are currently pregnant or breastfeeding.
7. Any prescheduled elective procedure during the study period that, in the opinion of the Investigator, would interfere with study parameters.
8. Any other condition, clinical finding, or reason that, in the opinion of the Investigator, is determined to be unsuitable for enrollment into this study



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Relapsing Forms of Multiple Sclerosis
MedDRA version: 17.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: Tysabri
Product Name: Tysabri
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)

Primary end point(s): The primary endpoint of the open label study is the incidence of AEs and SAEs.

Timepoint(s) of evaluation of this end point: When there's an incidence of AEs and SAEs

Main Objective: The primary objective for this study is long-term safety (incidence and pattern of SAEs) in patients receiving natalizumab.

Secondary Objective: Secondary objectives include long-term efficacy of natalizumab in delaying the progression of disability, reducing the frequency of relapses, MRI activity (for safety reasons) and explore quality of life and cognitive function in patients on treatment with natalizumab for more than 8 years.

Secondary Outcome(s)

Secondary end point(s): • Disability progression as determined by Expanded Disability Status Scale
(EDSS) (based on neurological examination, “physical EDSS”) every six
months
• MS disease activity as determined by the occurrence of clinical relapses
(distribution of the total number of relapses over 2 years)
• JCV status (anti-JCV antibody positive or negative according to the
STRATIFY JCV® Test, Unilabs, Denmark)
• Frequent MRI monitoring according to guidelines Belgian Study Group for
MS
• Quality of life measurement by EQ-5D every six months
• Cognitive evaluation by Symbol Digit Modalities Test (SDMT) every six
months

Timepoint(s) of evaluation of this end point: If patient doesn't want to participate anymore.

Secondary ID(s)

BEL-TYS-14-10675

Source(s) of Monetary Support

Biogen Idec