Relapsing-Remitting Multiple SclerosisPhase 2NCT00219908
Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis
A Phase 2 study testing Mitoxantrone in people with Relapsing-Remitting Multiple Sclerosis, run by Rennes University Hospital at 23 sites in 2 countries.
Trial summary
The aim of the study is to determine whether a therapeutic strategy combining mitoxantrone and interferon beta1b can delay disease progression of at least one point on EDSS scale in patients with clinically very active relapsing-remitting multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- Mitoxantrone
- How many people
- 124 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Jul 1999to Jun 2006
- Phase
- Phase 2
- 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 45 years
- No healthy volunteers
- Adult
Who may be able to join
- age : 18-45 years,
- Clinical disease satisfying the Poser criteria (Amdmt n°4)
- relapsing-remitting disease (Amdmt N°4)
- at least 2 exacerbations within the preceding 12 months, having left sequelae,
- MRI activity at inclusion expressed by at least one gadolinium-enhanced lesion (cranial MRI with 0.1mmol/kg gadolinium),
- a significant disability at inclusion: EDSS score between 2.5 and 5.5 (Amdt N° 4)
- written informed consent
Who cannot join
- pregnancy and breast-feeding
- use of an insufficiency effective contraceptive method,
- general immunosuppressive therapy using cyclophosphamide, mitoxantrone,or total lymphoid irradiation
- treatment with azathioprine during the 3 months preceding the study
- clinical relapse or intensive corticosteroid treatment within the 30 days preceding inclusion,
- associated disease (psychiatric disorder, depressive statenot controlled by appropriate drug therapy, history of heart disease at inclusion examination
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
France17 sites
Hôpital Cote de Nacre
Caen, 14033
Hôpital Gabriel Montpied
Clermont-Ferrand, 63003
CHU Henri Mondor
Créteil, 94000
Hôpital Général
Dijon, 21033
CHU Limoges
Limoges, 87042
Institut Catholique de Lille
Lomme, 59462
Pierre Weitheimer Hospital
Lyon, 69394
Chu Timone
Marseille, 13385
Centre Guy de Chauliac
Montpellier, 34295
CHU Hôpital Central
Nancy, 54035
CHU
Nice, 06000
CHU Pitié-Salpétrière
Paris, 75013
Hôpital Saint-Anne
Paris, 75014
Centre Fondation Rotschild
Paris, 75019
Tenon Hospital
Paris, 759170
CHU Strasbourg
Strasbourg, 67000
CHU Purpan
Toulouse, 31059
Italy6 sites
Psichiatriche dell'Università di Bari, Policlinico
Bari, 70122
Dipartimento di Scienze Neurologiche e Psichiatriche
Florence, 50134
Hospedal Civile
Gallarate, 21013
Neuroriabilitazione dell'Università
Genova, 16132
Fondazionz SAN Raffaele del monte tabor
Milan, 20132
Clinica Neurologica Università di Torino
Torino, 10126
About this study
Official title: Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis: Induction Treatment With Mitoxantrone Followed by Long-Term Treatment With Interferon-beta1b
The aim of the study is to determine whether a therapeutic strategy combining mitoxantrone and interferon beta1b can delay disease progression of at least one point on EDSS scale in patients with clinically very active relapsing-remitting multiple sclerosis.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- Mitoxantrone
- Keywords
- Multiple sclerosis, Mitoxantrone, Methylprednisolone, Interferon beta1b, Relapse, MRI, EDSS
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoxantroneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to confirmed progression of at least one EDSS point during the 3 years of the study.
Secondary outcomes (5)
- percentage of patients with confirmed progression of at least one point EDSS (confirmed at 3 and 6 months) during the 3 years of the study,
- annual rate of relapse;
- percentage of relapse-free patients during the study period,
- quality of life,
- percentage of patients without evidence of disease activity on serial MRIs at months 9, 24 and 36 (number of contrast-enhanced lesions on the annual MRIs, change in lesion burden).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 1999
- Study completionJun 2006
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 Rennes University HospitalThe 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
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Wyeth is now a wholly owned subsidiary of Pfizer, Farmades, Italy
- Investigators
- Gilles EDAN, Professor, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219908
- Sponsor's protocol ID
- 981166
- Status last verified
- Sep 2005
- First submitted
- 16 Sep 2005
- Last updated
- 22 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis: Induction Treatment With Mitoxantrone Followed by Long-Term Treatment With Interferon-beta1b
- ClinicalTrials.gov ID
- NCT00219908
- Acronym / sponsor ID
- 981166
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Multiple sclerosis, Mitoxantrone, Methylprednisolone, Interferon beta1b, Relapse, MRI, EDSS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 124 participants
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Bayer, Wyeth is now a wholly owned subsidiary of Pfizer, Farmades, Italy
- Study start
- Jul 1999
- Study completion
- Jun 2006
- First posted
- 22 Sep 2005 (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 aim of the study is to determine whether a therapeutic strategy combining mitoxantrone and interferon beta1b can delay disease progression of at least one point on EDSS scale in patients with clinically very active relapsing-remitting multiple sclerosis.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age : 18-45 years,
- Clinical disease satisfying the Poser criteria (Amdmt n°4)
- relapsing-remitting disease (Amdmt N°4)
- at least 2 exacerbations within the preceding 12 months, having left sequelae,
- MRI activity at inclusion expressed by at least one gadolinium-enhanced lesion (cranial MRI with 0.1mmol/kg gadolinium),
Key exclusion criteria (6 listed)
- pregnancy and breast-feeding
- use of an insufficiency effective contraceptive method,
- general immunosuppressive therapy using cyclophosphamide, mitoxantrone,or total lymphoid irradiation
- treatment with azathioprine during the 3 months preceding the study
- clinical relapse or intensive corticosteroid treatment within the 30 days preceding inclusion,
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 |
|---|---|---|
| Mitoxantrone | Drug | – |
Primary outcome
Time to confirmed progression of at least one EDSS point during the 3 years of the study.
5 secondary outcomes
- percentage of patients with confirmed progression of at least one point EDSS (confirmed at 3 and 6 months) during the 3 years of the study,
- annual rate of relapse;
- percentage of relapse-free patients during the study period,
- quality of life,
- percentage of patients without evidence of disease activity on serial MRIs at months 9, 24 and 36 (number of contrast-enhanced lesions on the annual MRIs, change in lesion burden).
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2005.
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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.
Gilles EDAN, Professor study director
Rennes University Hospital
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitoxantrone in people with Relapsing-Remitting Multiple Sclerosis, run by Rennes University Hospital at 23 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 22 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France, Italy. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
Time to confirmed progression of at least one EDSS point during the 3 years of the study.. 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 22 Dec 2005.