Multiple Sclerosis, Relapsing-RemittingPhase 4GRACENCT01420055
Fingolimod -Response According to Coping - Evaluation
A Phase 4 study testing fingolimod in people with Multiple Sclerosis, Relapsing-Remitting, run by Novartis Pharmaceuticals at 47 sites in France.
Trial summary
This is a prospective, open-label, multi-center phase IV study to assess response to fingolimod initiation according to coping profile in adult patients with highly active relapsing remitting multiple sclerosis in France. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- fingolimod
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 47 sitesFrance
- Study dates
- Aug 2011to Jun 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 year-old male \& female with RRMS (2005 revised McDonald criteria) corresponding to fingolimod indication (in Europe) and EDSS score 0 - 5.5 inclusive
Who cannot join
- History of immune system chronic disease other than MS or known immunodeficiency syndrome; increased risk for opportunistic infections, including immunocompromised patients; severe active infections, active chronic infections; negative for varicella-zoster virus IgG antibodies; live or live attenuated vaccines;
- Active malignancies; Macular edema; Cardiac disease or medicines decreasing heart rate; severe liver impairment; lymphocyte count <800/mm3;
- Pregnant or nursing (lactating) women /child-bearing potential UNLESS they are using an effective contraceptive method;
- Hypersensitivity; participation in any clinical research study within 6 months prior to baseline; prior participation in a trial with fingolimod
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
France47 sites
Novartis Investigative Site
Agen, 47923
Novartis Investigative Site
Amiens, 80054
Novartis Investigative Site
Angers, France, 49033
Novartis Investigative Site
Auxerre, 89000
Novartis Investigative Site
Avignon, 84000
Novartis Investigative Site
Bayonne, 64109
Novartis Investigative Site
Béziers, 34525
Novartis Investigative Site
Bobigny, 93009
Novartis Investigative Site
Brest, 29240
Novartis Investigative Site
Calais, 62107
Novartis Investigative Site
Castelnau-le-Lez, 34170
Novartis Investigative Site
Chambray-lès-Tours, 37175
Novartis Investigative Site
Cherbourg, 50100
Novartis Investigative Site
Clermont-Ferrand, 63003
Novartis Investigative Site
Créteil, 94010
Novartis Investigative Site
Dijon, 21034
Novartis Investigative Site
Épinal, 88021
Novartis Investigative Site
Grenoble, 38042
Novartis Investigative Site
Hagueneau, 67500
Novartis Investigative Site
La Rochelle, 17019
Novartis Investigative Site
La Seyne-sur-Mer, 83500
Novartis Investigative Site
Le Kremlin-Bicêtre, 94275
Novartis Investigative Site
Le Mans, 72037
Novartis Investigative Site
Limoges
Novartis Investigative Site
Lyon, 69275
Novartis Investigative Site
Marseille, 13008
Novartis Investigative Site
Marseille, 13012
Novartis Investigative Site
Metz, 57085
Novartis Investigative Site
Montpellier, 34000
Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Nîmes, 32900
Novartis Investigative Site
Orsay, 91401
Novartis Investigative Site
Paris, 75005
Novartis Investigative Site
Poitiers, 86021
Novartis Investigative Site
Pontoise, F-95300
Novartis Investigative Site
Reims, 51092
Novartis Investigative Site
Rennes, 35033
Novartis Investigative Site
Roanne, 42328
Novartis Investigative Site
Saint-Aubin-sur-Scie, 76550
Novartis Investigative Site
Saint-Jean, 31243
Novartis Investigative Site
Sainte-Foy-lès-Lyon, 69110
Novartis Investigative Site
Saumur, 49400
Novartis Investigative Site
Strasbourg, 67091
Novartis Investigative Site
Talant, 21240
Novartis Investigative Site
Toulouse, 31059
Novartis Investigative Site
Tourcoing, 59200
Novartis Investigative Site
Tours, 37044
About this study
Official title: A 4-month, Prospective, Open-label, Multi-center Phase IV Study to Assess Response to Fingolimod Initiation According to Coping Profile in Adult Patients With Highly Active Relapsing Remitting Multiple Sclerosis in France
This is a prospective, open-label, multi-center phase IV study to assess response to fingolimod initiation according to coping profile in adult patients with highly active relapsing remitting multiple sclerosis in France.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- fingolimod
- Keywords
- Multiple sclerosis, Fingolimod, Coping, Anxiety, France, Treatment Satisfaction Questionnaire for Medication-9 items (TSQM 9), Active
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fingolimodDrug
| Study group | Role | What they receive |
|---|---|---|
| fingolimod | Experimental | Not described Receives: Drug: fingolimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the mean change in Hospital Anxiety Depression Scale (HADS) anxiety sub-score between baseline and Month 4 in RRMS fingolimod treated patient total population, and according to coping profile (task, emotion or avoidance oriented).
Measured: 4 months
Secondary outcomes (3)
To assess patient Clinical Global Impression (CGI) and clinician CGI at M4 in total population, and according to coping profile.
Measured: 4 months
To evaluate the safety and tolerability of fingolimod 0.5 mg/day (especially initial cardiac effects, liver function and macular edema onset)
Measured: 4 months
To explore treatment satisfaction with fingolimod in patients with RRMS either naive (rapidly evolving severe RRMS) or who transitioned from previous treatment with Disease Modifying Therapy using the TSQM 9 and according to coping profile
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420055
- Sponsor's protocol ID
- CFTY720DFR03
- Other IDs
- 2011-001280-49
- Acronym
- GRACE
- Status last verified
- Nov 2016
- First submitted
- 17 Aug 2011
- Last updated
- 18 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-month, Prospective, Open-label, Multi-center Phase IV Study to Assess Response to Fingolimod Initiation According to Coping Profile in Adult Patients With Highly Active Relapsing Remitting Multiple Sclerosis in France
- ClinicalTrials.gov ID
- NCT01420055
- Acronym / sponsor ID
- GRACE / CFTY720DFR03
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple sclerosis, Fingolimod, Coping, Anxiety, France, Treatment Satisfaction Questionnaire for Medication-9 items (TSQM 9), Active
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Aug 2011 (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.
This is a prospective, open-label, multi-center phase IV study to assess response to fingolimod initiation according to coping profile in adult patients with highly active relapsing remitting multiple sclerosis in France.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fingolimod | Experimental | Drug: fingolimod |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-65 year-old male \& female with RRMS (2005 revised McDonald criteria) corresponding to fingolimod indication (in Europe) and EDSS score 0 - 5.5 inclusive
Key exclusion criteria (5 listed)
- History of immune system chronic disease other than MS or known immunodeficiency syndrome; increased risk for opportunistic infections, including immunocompromised patients; severe active infections, active chronic infections; negative for varicella-zoster virus IgG antibodies; live or live attenuated vaccines;
- Active malignancies; Macular edema; Cardiac disease or medicines decreasing heart rate; severe liver impairment; lymphocyte count <800/mm3;
- Pregnant or nursing (lactating) women /child-bearing potential UNLESS they are using an effective contraceptive method;
- Hypersensitivity; participation in any clinical research study within 6 months prior to baseline; prior participation in a trial with fingolimod
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| fingolimod | Drug | fingolimod |
Primary outcome
To assess the mean change in Hospital Anxiety Depression Scale (HADS) anxiety sub-score between baseline and Month 4 in RRMS fingolimod treated patient total population, and according to coping profile (task, emotion or avoidance oriented).
Time frame: 4 months
3 secondary outcomes
To assess patient Clinical Global Impression (CGI) and clinician CGI at M4 in total population, and according to coping profile.
Time frame: 4 months
To evaluate the safety and tolerability of fingolimod 0.5 mg/day (especially initial cardiac effects, liver function and macular edema onset)
Time frame: 4 months
To explore treatment satisfaction with fingolimod in patients with RRMS either naive (rapidly evolving severe RRMS) or who transitioned from previous treatment with Disease Modifying Therapy using the TSQM 9 and according to coping profile
Time frame: 4 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 18 Nov 2016.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fingolimod in people with Multiple Sclerosis, Relapsing-Remitting, run by Novartis Pharmaceuticals at 47 sites in France.
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 1 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 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in France. 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?
To assess the mean change in Hospital Anxiety Depression Scale (HADS) anxiety sub-score between baseline and Month 4 in RRMS fingolimod treated patient total population, and according to coping profile (task, emotion or avoidance oriented). (time frame: 4 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 18 Nov 2016.