Multiple SclerosisPhase 4NCT00267319
FOCUS Fatigue Outcome in Copaxone USers
A Phase 4 study testing Glatiramer acetate in people with Multiple Sclerosis, run by Sanofi at 1 site in Czechia.
Trial summary
The study primarily investigates the effect of copaxone on fatigue during treatment, compared to baseline in patients with relapsing-remitting multiple sclerosis. Secondary outcome measures are:disability, relapse rate, quality of life and depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Glatiramer acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteCzechia
- Study dates
- Jun 2003to Oct 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- relapsing-remitting Multiple Sclerosis (MS),
- at least 2 relapses in previous 2 years prior to copaxone or interferon beta treatment,
- ambulant patients i.e disability score EDSS MAX 5,5,
- clinically stable MS
- relapse free and steroid free at least 30 days prior to start copaxone treatment
Who cannot join
- hypersensitivity to glatiramer acetate or mannitol,
- pregnancy,
- fertile female not willing to use effective contraception,
- previous treatment with copaxone
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis
- The study primarily investigates the effect of copaxone on fatigue during treatment, compared to baseline in patients with relapsing-remitting multiple sclerosis.
- Secondary outcome measures are:disability, relapse rate, quality of life and depression.
- Conditions
- Multiple Sclerosis
- Being tested
- Glatiramer acetate
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glatiramer acetateDrug
| Study group | Role | What they receive |
|---|---|---|
| single group | Experimental | Not described Receives: Drug: Glatiramer acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue impact scale
Measured: at baseline, month 6 and month 12
Secondary outcomes (5)
relapse rate
Measured: at baseline, month 6 and month 12
quality of life
Measured: at baseline, month 6 and month 12
depression
Measured: at baseline, month 6 and month 12
disability
Measured: at baseline, month 6 and month 12
Adverse events
Measured: at baseline, month 6 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2005 (estimated)
- Study startJun 2003
- Primary completionOct 2006
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.
- More trials run by SanofiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Zuzana Priborska, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267319
- Sponsor's protocol ID
- HMR4002A_4002
- Status last verified
- Dec 2009
- First submitted
- 19 Dec 2005
- Last updated
- 7 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00267319
- Acronym / sponsor ID
- HMR4002A_4002
- Conditions
- Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Oct 2006 (actual)
- First posted
- 20 Dec 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 study primarily investigates the effect of copaxone on fatigue during treatment, compared to baseline in patients with relapsing-remitting multiple sclerosis.
- Secondary outcome measures are:disability, relapse rate, quality of life and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group | Experimental | Drug: Glatiramer acetate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- relapsing-remitting Multiple Sclerosis (MS),
- at least 2 relapses in previous 2 years prior to copaxone or interferon beta treatment,
- ambulant patients i.e disability score EDSS MAX 5,5,
- clinically stable MS
- relapse free and steroid free at least 30 days prior to start copaxone treatment
Key exclusion criteria (5 listed)
- hypersensitivity to glatiramer acetate or mannitol,
- pregnancy,
- fertile female not willing to use effective contraception,
- previous treatment with copaxone
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 acetate | Drug | single group |
Primary outcome
fatigue impact scale
Time frame: at baseline, month 6 and month 12
5 secondary outcomes
relapse rate
Time frame: at baseline, month 6 and month 12
quality of life
Time frame: at baseline, month 6 and month 12
depression
Time frame: at baseline, month 6 and month 12
disability
Time frame: at baseline, month 6 and month 12
Adverse events
Time frame: at baseline, month 6 and month 12
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 7 Dec 2009.
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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.
Zuzana Priborska study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glatiramer acetate in people with Multiple Sclerosis, run by Sanofi at 1 site in Czechia.
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 5 inclusion and 5 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 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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 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.
What does the primary outcome measure?
fatigue impact scale (time frame: at baseline, month 6 and month 12). 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 7 Dec 2009.