Relapsing-Remitting Multiple SclerosisTRUSTNCT00818038
A Proof of Concept Study to Evaluate the Effectiveness of Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) Patient Bladder Function
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Biogen.
Trial summary
The primary objective of the study was to measure the change in bladder function as measured by Urogenital Distress Inventory (UDI)-6 compared to baseline over 6 months of Tysabri treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- BG0002 (natalizumab)
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Mar 2011
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women 18 years or older with relapsing remitting multiple sclerosis who have never received an infusion of TYSABRI.
Who may be able to join
- Participants are eligible to be screened for this study if all of the following criteria are met:
- Patient must meet all prescribing criteria for TYSABRI® and eligible for the TOUCH™ program.
- If utilizing medications for symptoms of bladder dysfunction (such as incontinence, urgency etc), subjects will need to remain on a stable dose of medication(s) for at least one month prior to and for duration of study.
- If utilizing medications that affect urinary output (e.g. anticholinergics, diuretics, etc.), subjects will need to remain on a stable dose of medication(s) for at least one month prior to study entry and for the duration of the study.
- Able to provide written informed consent.
- Patient must be willing to maintain current hydration habits and caffeine intake for the duration of the study.
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- Participants will be selected for enrollment if all of the following criteria are met:
- Screening Visit urinary incontinence defined as:
- Greater than or equal to 3 incontinence episodes per week or greater than or equal to 8 micturitions per day (both mean numbers).
- Screening Visit score on the UDI-6 of more than or equal to 6.
- Screening Visit EDSS 0 - 6.5
Who cannot join
- Candidates will be excluded from study screening if any of the following exclusion criteria exist:
- Primary progressive, secondary progressive, or progressive relapsing MS. Primary progressive, secondary progressive or progressive relapsing multiple sclerosis are defined by Lublin and Reingold (Lublin and Reingold, 1996) or EDSS >6.5.
- Current or previous history of Progressive Multifocal Leukencephalopathy (PML).
- A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days.
- History of recurrent or chronic urinary tract infection or a urinary tract infection within the preceding 30 days prior to Week 0 (diagnosis based on clinical history and Screening Visit urinalysis and urine culture).
- Patients who have in-dwelling foley catheter or a suprapubic catheter.
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- Patients with a history of symptomatic benign prostatic hyperplasia (BPH) or a history of prostate cancer.
- History of, or abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, and/or other major disease, that, in the opinion of the investigator, would preclude the administration of natalizumab for the duration of the study.
- Subject with history of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been treated.
- History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
- Any prior treatment with the following medications: Natalizumab (TYSABRI®)
- Nursing mothers, pregnant women, and women planning to become pregnant while in study.
- Any other reasons that, in the opinion of the Investigator and/or Sponsor, the subject is determined to be unsuitable for enrollment into this study.
- Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol.
- History of alcohol or drug abuse within 2 years prior to randomization.
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to use a medically acceptable method of birth control during the study. The rhythm method is not to be used as the sole method of contraception.
- Participants will be determined as screen failures if any of the following criteria apply:
- Abnormal blood tests, performed at the screening visit, which exceed any of the limits defined below:
- ALT/ SGPT, or AST/ SGOT more than three times the upper limit of normal (i.e., 3xULN).
- Total white blood cell (WBC) count less than 2,300/mm3.
- Platelet count less than 100,000/mm3.
- Creatinine more than 2xULN.
- Screening Visit urinary incontinence defined as less than 3 incontinence episodes per week or less than 8 micturitions per day (both mean numbers).
- Screening Visit score on the UDI-6 of less than 6.
- Screening Visit EDSS more than 6.5.
- NOTE: Other protocol defined inclusion/exclusion criteria may apply.
About this study
Official title: Phase IV, Proof of Concept Study to Evaluate Tysabri Effectiveness in RRMS Patient Bladder Function
The primary objective of the study was to measure the change in bladder function as measured by Urogenital Distress Inventory (UDI)-6 compared to baseline over 6 months of Tysabri treatment. Secondary objectives were to (i) measure change from baseline over 6 months of Tysabri treatment in the number of urinary incontinence episodes per participant per week, (ii) measure change from baseline over 6 months of Tysabri treatment in the number of micturitions per participant per day, (iii) measure change in The North American Research Committee on Multiple Sclerosis (NARCOMS) bladder/bowel subscale (PSB) scores from baseline over 6 months of Tysabri treatment and (iv) measure change in Incontinence Impact Questionnaire (IIQ)-7 scores from baseline over 6 months of Tysabri treatment.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- BG0002 (natalizumab)
- Keywords
- RRMS, Relapsing Remitting, MS
- 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.
BG0002 (natalizumab)Drug
Also called TYSABRI
Participants who are newly prescribed TYSABRI, but have not received their first infusion, will be invited to participate.
| Study group | Role | What they receive |
|---|---|---|
| TYSABRI | Participants who are newly prescribed TYSABRI, but have not received their first infusion, will be invited to participate. Receives: Drug: BG0002 (natalizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bladder function as measured by UDI-6 compared to baseline over 6 months of TYSABRI treatment.
Measured: Baseline and 6 months
Secondary outcomes (4)
Change from baseline over 6 months of TYSABRI treatment in the number of urinary incontinence episodes per participant per week.
Measured: Baseline and 6 months
Change from baseline over 6 months of TYSABRI treatment in the number of micturitions per participant per day.
Measured: Baseline and 6 months
Change in NARCOMS PSB scores from baseline over 6 months of TYSABRI treatment.
Measured: Baseline and 6 months
Change in IIQ-7 scores from baseline over 6 months of TYSABRI treatment.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2011
- Study completionMar 2011
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
- Prospective
- Enrolment
- 30 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
- NCT00818038
- Sponsor's protocol ID
- US 006-08-NAT
- Acronym
- TRUST
- Status last verified
- Jun 2014
- First submitted
- 5 Jan 2009
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Proof of Concept Study to Evaluate Tysabri Effectiveness in RRMS Patient Bladder Function
- ClinicalTrials.gov ID
- NCT00818038
- Acronym / sponsor ID
- TRUST / US 006-08-NAT
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- RRMS, Relapsing Remitting, MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Jan 2009 (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 was to measure the change in bladder function as measured by Urogenital Distress Inventory (UDI)-6 compared to baseline over 6 months of Tysabri treatment. Secondary objectives were to (i) measure change from baseline over 6 months of Tysabri treatment in the number of urinary incontinence episodes per participant per week, (ii) measure change from baseline over 6 months of Tysabri treatment in the number of micturitions per participant per day, (iii) measure change in The North American Research Committee on Multiple Sclerosis (NARCOMS) bladder/bowel subscale (PSB) scores from baseline over 6 months of Tysabri treatment and (iv) measure change in Incontinence Impact Questionnaire (IIQ)-7 scores from baseline over 6 months of Tysabri treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TYSABRI | – | Drug: BG0002 (natalizumab)Participants who are newly prescribed TYSABRI, but have not received their first infusion, will be invited to participate. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women 18 years or older with relapsing remitting multiple sclerosis who have never received an infusion of TYSABRI.
Key inclusion criteria (11 listed)
- Participants are eligible to be screened for this study if all of the following criteria are met:
- Patient must meet all prescribing criteria for TYSABRI® and eligible for the TOUCH™ program.
- If utilizing medications for symptoms of bladder dysfunction (such as incontinence, urgency etc), subjects will need to remain on a stable dose of medication(s) for at least one month prior to and for duration of study.
- If utilizing medications that affect urinary output (e.g. anticholinergics, diuretics, etc.), subjects will need to remain on a stable dose of medication(s) for at least one month prior to study entry and for the duration of the study.
- Able to provide written informed consent.
Key exclusion criteria (26 listed)
- Candidates will be excluded from study screening if any of the following exclusion criteria exist:
- Primary progressive, secondary progressive, or progressive relapsing MS. Primary progressive, secondary progressive or progressive relapsing multiple sclerosis are defined by Lublin and Reingold (Lublin and Reingold, 1996) or EDSS >6.5.
- Current or previous history of Progressive Multifocal Leukencephalopathy (PML).
- A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days.
- History of recurrent or chronic urinary tract infection or a urinary tract infection within the preceding 30 days prior to Week 0 (diagnosis based on clinical history and Screening Visit urinalysis and urine culture).
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 |
|---|---|---|
| BG0002 (natalizumab)Also: TYSABRIParticipants who are newly prescribed TYSABRI, but have not received their first infusion, will be invited to participate. | Drug | TYSABRI |
Primary outcome
Change in bladder function as measured by UDI-6 compared to baseline over 6 months of TYSABRI treatment.
Time frame: Baseline and 6 months
4 secondary outcomes
Change from baseline over 6 months of TYSABRI treatment in the number of urinary incontinence episodes per participant per week.
Time frame: Baseline and 6 months
Change from baseline over 6 months of TYSABRI treatment in the number of micturitions per participant per day.
Time frame: Baseline and 6 months
Change in NARCOMS PSB scores from baseline over 6 months of TYSABRI treatment.
Time frame: Baseline and 6 months
Change in IIQ-7 scores from baseline over 6 months of TYSABRI treatment.
Time frame: Baseline and 6 months
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 27 Jun 2014.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Biogen.
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 11 inclusion and 26 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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 in bladder function as measured by UDI-6 compared to baseline over 6 months of TYSABRI treatment. (time frame: Baseline and 6 months). 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 27 Jun 2014.