Relapsing-Remitting Multiple SclerosisNCT02677077
Clinical Disease Activity With Long Term Natalizumab Treatment
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Biogen at 4 sites in 2 countries.
Trial summary
The primary objective of the study is to retrospectively investigate the proportion of participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants with regular MRI follow-up, who have received… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- natalizumab
- How many people
- 277 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 31 Dec 2015to 18 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who have been receiving treatment with natalizumab for ≥24 months.
Who may be able to join
- Diagnosis of RRMS.
- Continuous treatment with natalizumab of ≥24 months. In case of a treatment interruption from natalizumab ≥60 days after a total treatment period of ≥24 months, only the treatment prior to the interruption will be analyzed. Any data after this treatment interruption (even if the patient restarts natalizumab) will not be analyzed/collected.
- ≥1 MRI scan of sufficient quality for reliable measurement.
- Baseline MRI scan ≤6 month prior to natalizumab treatment acquired.
- ≥1 MRI scan of sufficient quality for reliable measurement taken while on natalizumab treatment for ≥6 months.
- EDSS ≤ 6.5.
Who cannot join
- Anti-natalizumab antibody detection.
- Prior treatment with alemtuzumab.
- Prior treatment with mitoxantrone within 12 months of the first infusion of natalizumab.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Belgium3 sites
Research Site 1
Brussels
Research Site 2
Brussels
Research Site
Overpelt
About this study
Official title: MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab
The primary objective of the study is to retrospectively investigate the proportion of participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants with regular MRI follow-up, who have received natalizumab ≥24 month from two different observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2) approximately 70 participants from Belgium. The secondary objectives of this study are as follows: Brain volume change by various measures; Changes in the number and volume of magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and without brain volume change.
Read the detailed description
Natalizumab will not be provided to participants by Biogen as a part of this study. Participants will remain on natalizumab therapy as prescribed by their physician.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- natalizumab
- Keywords
- RRMS, MRI
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natalizumabDrug
Also called BG00002, Tysabri
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
| Study group | Role | What they receive |
|---|---|---|
| Czech Republic | Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic Receives: Drug: natalizumab | |
| Belgium | Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium Receives: Drug: natalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time in the number of participants free of new or enlarging FLAIR lesions
Lesions that are ≥5 mm per scan (slice thickness 3 mm) as assessed by semiautomatic lesion count (by the Icometrix algorithm).
Measured: Treatment years 3 and 4
Secondary outcomes (10)
Annualized brain volume change rate as assessed by % change in brain parenchymal fraction [BPF]
Measured: Post long term treatment with natalizumab (>2 years) through Year 4
Annualized brain volume change rate as assessed by percent brain volume change [PBVC]
Measured: Post long term treatment with natalizumab (>2 years) through Year 4
Annualized brain volume change rate as assessed by white matter [WM] and gray matter [GM] atrophy)
Measured: Post long term treatment with natalizumab (>2 years) through Year 4
Cumulative number of new ≥6-month confirmed T1-hypointense lesions
Measured: Post long term treatment with natalizumab (>2 years) through Year 4
Annualized T1-hypointense and FLAIR lesion volume change
Measured: Post long term treatment with natalizumab (>2 years) through Year 4
Cumulative percent change in T1-hypointense and FLAIR lesion volume
Measured: Post long term treatment with natalizumab (>2 years) through Year 4
Cumulative number of ≥6-month-confirmed T1-hypointense lesions arising from new on- treatment Gadolinium (Gd+)-enhancing lesions
No relapse and no ≥6-month confirmed Expanded Disability Status Scale (EDSS) progression and no new or enlarging FLAIR lesions and no new Gd+-enhancing lesions
Measured: Post long term treatment with natalizumab (>2 years) through Year 4
Number of total participants and 4-year completers with NEDA as measured by clinical measures
No relapse and no ≥6-month confirmed EDSS progression and no new or enlarging FLAIR lesions and no new Gd+-enhancing lesions, brain volume change rate as assessed by PBVC
Measured: Post long term treatment with natalizumab (>2 years) through Year 4
Number of total participants and 4-year completers with NEDA as measured by radiological measures
No new or enlarging FLAIR lesions and no new Gd+-enhancing lesions
Measured: Post long term treatment with natalizumab (>2 years) through Year 4
Number of participants with brain volume loss ≤0.2% and ≤0.4%
Measured: Post long term treatment with natalizumab (>2 years) through Year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study start31 Dec 2015
- Primary completion18 Aug 2016
- Study completion18 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677077
- Sponsor's protocol ID
- BEL-TYS-14-10727
- Status last verified
- Dec 2018
- First submitted
- 3 Dec 2015
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab
- ClinicalTrials.gov ID
- NCT02677077
- Acronym / sponsor ID
- BEL-TYS-14-10727
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- RRMS, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2015 (actual)
- Primary completion
- 18 Aug 2016 (actual)
- Study completion
- 18 Aug 2016 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to retrospectively investigate the proportion of participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants with regular MRI follow-up, who have received natalizumab ≥24 month from two different observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2) approximately 70 participants from Belgium. The secondary objectives of this study are as follows: Brain volume change by various measures; Changes in the number and volume of magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and without brain volume change.
Detailed description
Natalizumab will not be provided to participants by Biogen as a part of this study. Participants will remain on natalizumab therapy as prescribed by their physician.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Czech Republic | – | Drug: natalizumabApproximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic |
| Belgium | – | Drug: natalizumabApproximately 70 participants with RRMS receiving commercial natalizumab in Belgium |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have been receiving treatment with natalizumab for ≥24 months.
Key inclusion criteria (6 listed)
- Diagnosis of RRMS.
- Continuous treatment with natalizumab of ≥24 months. In case of a treatment interruption from natalizumab ≥60 days after a total treatment period of ≥24 months, only the treatment prior to the interruption will be analyzed. Any data after this treatment interruption (even if the patient restarts natalizumab) will not be analyzed/collected.
- ≥1 MRI scan of sufficient quality for reliable measurement.
- Baseline MRI scan ≤6 month prior to natalizumab treatment acquired.
- ≥1 MRI scan of sufficient quality for reliable measurement taken while on natalizumab treatment for ≥6 months.
Key exclusion criteria (4 listed)
- Anti-natalizumab antibody detection.
- Prior treatment with alemtuzumab.
- Prior treatment with mitoxantrone within 12 months of the first infusion of natalizumab.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| natalizumabAlso: BG00002, TysabriParticipants with RRMS receiving commercial natalizumab in Belgium and Czech Republic | Drug | Belgium, Czech Republic |
Primary outcome
Change over time in the number of participants free of new or enlarging FLAIR lesions
Time frame: Treatment years 3 and 4
Lesions that are ≥5 mm per scan (slice thickness 3 mm) as assessed by semiautomatic lesion count (by the Icometrix algorithm).
10 secondary outcomes
Annualized brain volume change rate as assessed by % change in brain parenchymal fraction [BPF]
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Annualized brain volume change rate as assessed by percent brain volume change [PBVC]
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Annualized brain volume change rate as assessed by white matter [WM] and gray matter [GM] atrophy)
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Cumulative number of new ≥6-month confirmed T1-hypointense lesions
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Annualized T1-hypointense and FLAIR lesion volume change
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Cumulative percent change in T1-hypointense and FLAIR lesion volume
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Cumulative number of ≥6-month-confirmed T1-hypointense lesions arising from new on- treatment Gadolinium (Gd+)-enhancing lesions
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Number of total participants and 4-year completers with NEDA as measured by clinical measures
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Number of total participants and 4-year completers with NEDA as measured by radiological measures
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Number of participants with brain volume loss ≤0.2% and ≤0.4%
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Biogen at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change over time in the number of participants free of new or enlarging FLAIR lesions (time frame: Treatment years 3 and 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.