Relapsing-Remitting Multiple SclerosisiTOPNCT01943526
Ireland Natalizumab (TYSABRI) Observational Program
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Biogen at 5 sites in Ireland.
Trial summary
The objectives of this study are to assess the long-term safety and impact on disease activity and progression of natalizumab (Tysabri) in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- natalizumab
- How many people
- 191 participants
- Where
- 5 sitesIreland
- Study dates
- 30 Nov 2011to 31 Dec 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with RRMS who are being treated with natalizumab and patients who meet the criteria defined in the indication statement for prescription in Ireland. Existing patients will be enrolled retrospectively.
Who may be able to join
- Must give written informed consent and assent, as applicable.
- Decision to treat with natalizumab must precede enrollment.
- Patient characteristics and contraindications to treatment with natalizumab in accordance with prescribing information.
- Must be receiving natalizumab (Tysabri) for the treatment of RRMS in accordance with the natalizumab indication statement.
- Must have a documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Ireland5 sites
Research site
Cork, County Cork
Research site
Dublin, County Dublin
Research site
Galway, County Galway
Research site
Sligo, County Sligo
Research site
Tralee, County Kerry
About this study
Official title: Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)
The objectives of this study are to assess the long-term safety and impact on disease activity and progression of natalizumab (Tysabri) in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.
Read the detailed description
iTOP is a retrospective and prospective Irish observational study of participants receiving natalizumab, with each participant to be followed for 3 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of natalizumab with marketed use. Collection of efficacy and safety data at 6- monthly intervals to coincide with regular clinic visits and routine clinical practice will therefore be undertaken during the iTOP observational period.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- natalizumab
- Keywords
- Ireland, Natalizumab
- 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.
natalizumabBiological
Also called Tysabri, BG00002
Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing Serious Adverse Events (SAEs)
Measured: up to 3 years
Secondary outcomes (9)
Disability progression as determined by Expanded Disability Status Scale (EDSS)
Disability progression is defined as at least a 1.0 point increase on the EDSS from Baseline that is sustained over 6 months. The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Measured: Up to 3 years
MS disease activity as determined by annualized relapse rate (ARR)
A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. New or recurrent neurological symptoms that occur less than 30 days following the onset of a protocol-defined relapse should be considered part of the same relapse.
Measured: Up to 3 years
MS disease activity as determined by distribution of the total number of relapses during the study
Measured: Up to 3 years
MS disease activity as determined by time to first relapse
Measured: Up to 3 years
MS disease activity as determined by number of participants with relapse
Measured: Up to 3 years
MS disability progression and MS disease activity summarized for subpopulations according to baseline characteristics
Prognostic factors for disability progression and MS disease activity will be assessed in different participant cohorts stratified according to their baseline characteristics: Participant demographics including age, gender; Disease History, including diagnosis and duration at baseline; Baseline EDSS; Number of relapses within 1 and 2 years before baseline; MRI parameters at baseline; Prior use of disease modifying therapy, anti-neoplastic, immunosuppressant or immunomodulator therapy
Measured: Up to 3 years
MS disease activity as determined by MRI parameters
Measured: Up to 3 years
Evaluation of short-term disease outcomes as assessed by EDSS progression
Measured: Up to 1 year
Evaluation of short-term disease outcomes as assessed by occurrence of relapses
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study start30 Nov 2011
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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
- Case only
- Time perspective
- Other
- Enrolment
- 191 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
- NCT01943526
- Sponsor's protocol ID
- TYS-IRL-11-4
- Acronym
- iTOP
- Status last verified
- Apr 2018
- First submitted
- 12 Sep 2013
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)
- ClinicalTrials.gov ID
- NCT01943526
- Acronym / sponsor ID
- iTOP / TYS-IRL-11-4
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Ireland, Natalizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2011 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 17 Sep 2013 (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 objectives of this study are to assess the long-term safety and impact on disease activity and progression of natalizumab (Tysabri) in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.
Detailed description
iTOP is a retrospective and prospective Irish observational study of participants receiving natalizumab, with each participant to be followed for 3 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of natalizumab with marketed use. Collection of efficacy and safety data at 6- monthly intervals to coincide with regular clinic visits and routine clinical practice will therefore be undertaken during the iTOP observational period.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with RRMS who are being treated with natalizumab and patients who meet the criteria defined in the indication statement for prescription in Ireland. Existing patients will be enrolled retrospectively.
Key inclusion criteria (6 listed)
- Must give written informed consent and assent, as applicable.
- Decision to treat with natalizumab must precede enrollment.
- Patient characteristics and contraindications to treatment with natalizumab in accordance with prescribing information.
- Must be receiving natalizumab (Tysabri) for the treatment of RRMS in accordance with the natalizumab indication statement.
- Must have a documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).
Key exclusion criteria (0 listed)
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: Tysabri, BG00002Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician. | Biological | – |
Primary outcome
Number of participants experiencing Serious Adverse Events (SAEs)
Time frame: up to 3 years
9 secondary outcomes
Disability progression as determined by Expanded Disability Status Scale (EDSS)
Time frame: Up to 3 years
MS disease activity as determined by annualized relapse rate (ARR)
Time frame: Up to 3 years
MS disease activity as determined by distribution of the total number of relapses during the study
Time frame: Up to 3 years
MS disease activity as determined by time to first relapse
Time frame: Up to 3 years
MS disease activity as determined by number of participants with relapse
Time frame: Up to 3 years
MS disability progression and MS disease activity summarized for subpopulations according to baseline characteristics
Time frame: Up to 3 years
MS disease activity as determined by MRI parameters
Time frame: Up to 3 years
Evaluation of short-term disease outcomes as assessed by EDSS progression
Time frame: Up to 1 year
Evaluation of short-term disease outcomes as assessed by occurrence of relapses
Time frame: Up to 1 year
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 May 2018.
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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
5 sites in 1 country: 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 5 sites in Ireland.
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 0 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 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ireland. 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?
Number of participants experiencing Serious Adverse Events (SAEs) (time frame: up to 3 years). 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 May 2018.