Multiple SclerosisPhase 4MTX01NCT00037102
Combination Therapy With Avonex and BiMonthly High Dose Intravenous Methotrexate in Multiple Sclerosis
A Phase 4 study testing interferon beta 1a and methotrexate in people with Multiple Sclerosis, run by MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute.
Trial summary
The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and bi-monthly high dose intravenous methotrexate with Leucovorin rescue. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- interferon beta 1a and methotrexate
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to Dec 2003
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
To be eligible for entry into this study, candidates must meet the following eligibility criteria at the time of enrollment:
- Between the ages of 18 and 60 years, inclusive.
- Diagnosis of clinically definite relapsing MS.
- Must have been on AVONEX® therapy for at least six months.
- Brain MRI scans demonstrating lesions consistent with MS.
- Subject must have had at least one clinical exacerbation in the last year, and this must have occurred after having been on AVONEX® therapy for at least six to twelve (6-12) months. A clinical exacerbation is defined as a decrease of 0.1 in the MSFC composite or any of the subset domains scores administered 3 months apart.
- Give written informed consent prior to any testing under this protocol, including screening tests and evaluation that are not considered part of the subject's routine care.
To be eligible for treatment with methotrexate, subjects must have evidence for MS disease activity on their baseline screening MRI.
About this study
Official title: An Open Label Study of the Safety and Efficacy of Combination Therapy With AVONEX and Bi-Monthly High Dose Intravenous Methotrexate With Leucovorin Rescue in the Treatment of Multiple Sclerosis
The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and bi-monthly high dose intravenous methotrexate with Leucovorin rescue.
Read the detailed description
The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and bi-monthly high dose intravenous methotrexate with Leucovorin rescue. Entrance into the study will be based on Multiple Sclerosis Functional Composite Score (MSFC) evaluations at -4 months, and - 1 month prior to study, where a decrease in score is noted. The composite score consists of the Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT), and Paced Auditory Serial Addition Test 3 (PASAT 3). The patient must have been on AVONEX® for at least 6 months.
At study entrance, baseline lab work (complete blood count, platelet count, routine electrolytes, blood urea nitrogen, creatinine, liver function tests, 24 hour urine collection for creatinine clearance, and urine pH), an electrocardiogram (measurement of heart activity) and serum pregnancy test will be done. A complete physical examination will be performed, including measurements of vital signs (heart rate and blood pressure), as well as magnetic resonance imaging (MRI) to document status of disease. A self-administered questionnaire, the MSQLI (Multiple Sclerosis Quality of Life Instrument), will be completed at baseline and at the end of the study. MSFC and safety evaluations (previously mentioned blood and urine tests and electrocardiograms (EKG), will be conducted throughout the study at months 2, 4, 6, 8, 10, and 12. Blood tests of immune cells will also be drawn at these visits. The patient can continue this regimen of treatment at their own discretion and cost, and outside the parameters of this study, if there is apparent efficacy without serious adverse events. This treatment would be under the supervision of Dr. Rowe.
The patients will continue their AVONEX® intramuscular injections of 30 micrograms (administered by patient or caregiver) on a weekly basis with scheduled intravenous high dose methotrexate at 2 Gm/m2 followed by intravenous and oral leucovorin rescue once every 2 months. The methotrexate infusions will be performed in our outpatient infusion center. The patient will be required to complete a patient diary during the course of the trial, participate in and keep all scheduled appointments, and to inform the research staff and physician of any change in concomitant medications or adverse events that they may experience.
- Conditions
- Multiple Sclerosis
- Being tested
- interferon beta 1a, methotrexate
- Keywords
- Multiple Sclerosis, Relapsing, Methotrexate, AVONEX, interferon beta 1a, demyelinating, autoimmune
- Medical subject headings
- Multiple Sclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon beta 1aDrug
methotrexateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2002 (estimated)
- Study startJul 2001
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Consultants in Neurology, Biogen
- Responsible party
- Principal investigator, Vernon D. Rowe III, MD, MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
- Investigators
- Vernon D ROWE, MD, Principal investigator, MidAmerica Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037102
- Sponsor's protocol ID
- MANI-MTX01-001
- Acronym
- MTX01
- Status last verified
- Apr 2018
- First submitted
- 15 May 2002
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of the Safety and Efficacy of Combination Therapy With AVONEX and Bi-Monthly High Dose Intravenous Methotrexate With Leucovorin Rescue in the Treatment of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00037102
- Acronym / sponsor ID
- MTX01 / MANI-MTX01-001
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Relapsing, Methotrexate, AVONEX, interferon beta 1a, demyelinating, autoimmune
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- MidAmerica Neuroscience Research Foundation at Rowe Neurology InstituteUniversity, hospital or other
- Collaborators
- Consultants in Neurology, Biogen
- Study start
- Jul 2001
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 17 May 2002 (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 participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and bi-monthly high dose intravenous methotrexate with Leucovorin rescue.
Detailed description
The participant will receive weekly intramuscular treatment with AVONEX® (interferon beta 1-a) and bi-monthly high dose intravenous methotrexate with Leucovorin rescue. Entrance into the study will be based on Multiple Sclerosis Functional Composite Score (MSFC) evaluations at -4 months, and - 1 month prior to study, where a decrease in score is noted. The composite score consists of the Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT), and Paced Auditory Serial Addition Test 3 (PASAT 3). The patient must have been on AVONEX® for at least 6 months.
At study entrance, baseline lab work (complete blood count, platelet count, routine electrolytes, blood urea nitrogen, creatinine, liver function tests, 24 hour urine collection for creatinine clearance, and urine pH), an electrocardiogram (measurement of heart activity) and serum pregnancy test will be done. A complete physical examination will be performed, including measurements of vital signs (heart rate and blood pressure), as well as magnetic resonance imaging (MRI) to document status of disease. A self-administered questionnaire, the MSQLI (Multiple Sclerosis Quality of Life Instrument), will be completed at baseline and at the end of the study. MSFC and safety evaluations (previously mentioned blood and urine tests and electrocardiograms (EKG), will be conducted throughout the study at months 2, 4, 6, 8, 10, and 12. Blood tests of immune cells will also be drawn at these visits. The patient can continue this regimen of treatment at their own discretion and cost, and outside the parameters of this study, if there is apparent efficacy without serious adverse events. This treatment would be under the supervision of Dr. Rowe.
The patients will continue their AVONEX® intramuscular injections of 30 micrograms (administered by patient or caregiver) on a weekly basis with scheduled intravenous high dose methotrexate at 2 Gm/m2 followed by intravenous and oral leucovorin rescue once every 2 months. The methotrexate infusions will be performed in our outpatient infusion center. The patient will be required to complete a patient diary during the course of the trial, participate in and keep all scheduled appointments, and to inform the research staff and physician of any change in concomitant medications or adverse events that they may experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| interferon beta 1a | Drug | – |
| methotrexate | Drug | – |
Primary outcome
Not reported in the source record.
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 12 Apr 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.
Vernon D ROWE, MD principal investigator
MidAmerica Research Foundation
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing interferon beta 1a and methotrexate in people with Multiple Sclerosis, run by MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Apr 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 12 Apr 2018.