Relapsing Remitting Multiple SclerosisPhase 4NCT00202995
Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS
A Phase 4 study testing Glatiramer Acetate, Betaseron and Rebif in people with Relapsing Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
Randomized study designed to look at the difference in relapse rates between patients remaining on their current interferon medication and those switched to Copaxone® Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Glatiramer Acetate, Betaseron and Rebif
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Oct 2007
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have a diagnosis of clinically definite MS with a relapsing disease course as determined by the Poser criteria
- Patients must be on high dose interferon therapy (Betaseron® 250 µg or Rebif® 44 µg) for at least 1 year prior to study entry
- Patients must have experienced at least one documented relapse during the past year prior to screening. Pseudo-relapses must be ruled out. A gadolinium enhancing lesion is not required.
- Patients must be ambulatory, with a Kurtzke EDSS score between 0-5 inclusive
- Patients must be between the ages of 18 and 50 years inclusive
- Women of childbearing potential must practice an acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, double-barrier method (condom or IUD with spermicide), or partner's vasectomy
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- Patients must be relapse-free and off corticosteroids (IV or oral) for at least 30 days prior to the screening visit
- Patients must be relapse-free and off corticosteroids between the screening and baseline visits
- Patients must be willing and able to give written informed consent
Who cannot join
- Use of experimental or investigational drugs, and/or participation in an investigational drug study within 6 months prior to study entry
- Previous treatment with glatiramer acetate (injectable)
- Previous treatment with immunomodulators (except IFNβ), immunosuppressive agents, IVIG, or plasma exchange in the 6 months prior to screening; previous treatment with cladribine in the past 2 years
- Previous total body irradiation or total lymphoid irradiation
- Chronic corticosteroid (IV, IM, and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry
- Pregnancy or breastfeeding
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- Life-threatening or other clinically significant disease
- Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse
- A known sensitivity to gadolinium (gadolinium acid)
- A known history of sensitivity to mannitol
- Inability to successfully undergo MRI scanning
About this study
Official title: A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients
Randomized study designed to look at the difference in relapse rates between patients remaining on their current interferon medication and those switched to Copaxone®
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Glatiramer Acetate, Betaseron, Rebif
- 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.
Glatiramer AcetateDrug
20 mg s.c. daily
BetaseronDrug
250 mg every other day
RebifDrug
44 ug 3 times a week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Glatiramer Acetate 20 mg s.c. daily Receives: Drug: Glatiramer Acetate |
| 2 | Active comparator | Betaseron 250 ug every other day or Rebif 44 ug 3 times a week Receives: Drug: Betaseron; Drug: Rebif |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to compare the total number of confirmed relapses experienced by patients randomized to maintain treatment on high dose IFN therapy compared to those who were switched to Copaxone® treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: Slow enrollment decreased sample size No unexpected safety issues.
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Helene Brooks, Study director, Teva Neuroscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202995
- Sponsor's protocol ID
- 9013
- Status last verified
- Oct 2010
- First submitted
- 13 Sep 2005
- Last updated
- 18 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT00202995
- Acronym / sponsor ID
- 9013
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment decreased sample size No unexpected safety issues.
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 20 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.
Randomized study designed to look at the difference in relapse rates between patients remaining on their current interferon medication and those switched to Copaxone®
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Glatiramer AcetateGlatiramer Acetate 20 mg s.c. daily |
| 2 | Active comparator | Drug: Betaseron, Drug: RebifBetaseron 250 ug every other day or Rebif 44 ug 3 times a week |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients must have a diagnosis of clinically definite MS with a relapsing disease course as determined by the Poser criteria
- Patients must be on high dose interferon therapy (Betaseron® 250 µg or Rebif® 44 µg) for at least 1 year prior to study entry
- Patients must have experienced at least one documented relapse during the past year prior to screening. Pseudo-relapses must be ruled out. A gadolinium enhancing lesion is not required.
- Patients must be ambulatory, with a Kurtzke EDSS score between 0-5 inclusive
- Patients must be between the ages of 18 and 50 years inclusive
Key exclusion criteria (11 listed)
- Use of experimental or investigational drugs, and/or participation in an investigational drug study within 6 months prior to study entry
- Previous treatment with glatiramer acetate (injectable)
- Previous treatment with immunomodulators (except IFNβ), immunosuppressive agents, IVIG, or plasma exchange in the 6 months prior to screening; previous treatment with cladribine in the past 2 years
- Previous total body irradiation or total lymphoid irradiation
- Chronic corticosteroid (IV, IM, and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry
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 |
|---|---|---|
| Glatiramer Acetate20 mg s.c. daily | Drug | 1 |
| Betaseron250 mg every other day | Drug | 2 |
| Rebif44 ug 3 times a week | Drug | 2 |
Primary outcome
The primary objective of the study is to compare the total number of confirmed relapses experienced by patients randomized to maintain treatment on high dose IFN therapy compared to those who were switched to Copaxone® treatment.
Results and safety
The study was stopped early (reason given: Slow enrollment decreased sample size No unexpected safety issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2010.
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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.
Helene Brooks study director
Teva Neuroscience, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glatiramer Acetate, Betaseron and Rebif in people with Relapsing Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc..
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 9 inclusion and 11 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 18 Oct 2010. 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 was stopped early (reason given: Slow enrollment decreased sample size No unexpected safety issues.). 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?
The primary objective of the study is to compare the total number of confirmed relapses experienced by patients randomized to maintain treatment on high dose IFN therapy compared to those who were switched to Copaxone® treatment.. 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 18 Oct 2010.