Relapsing-remitting Multiple SclerosisPhase 4BiobankNCT01310166
Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
A Phase 4 study testing Fingolimod in people with Relapsing-remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 61 sites in Germany.
Trial summary
The purpose of this study is to investigate which changes in immunological biomarkers under treatment with fingolimod in patients with relapsing-remitting multiple sclerosis can be detected. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- Fingolimod
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- 61 sitesGermany
- Study dates
- Feb 2011to Jul 2012
- 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
- Subjects with relapsing forms of MS defined by 2005 revised McDonald criteria
- Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5
Who cannot join
- Patients with a manifestation of MS other than relapsing remitting MS
- Patients with a history of chronic disease of the immune system other than MS such as known immunodeficiency syndrome
- History or presence of malignancy in the last 5 years
- Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients
- Diagnosis of macular edema during Screening Phase
- Patients with active systemic bacterial, viral or fungal infections
Show all 11Show fewer
- Negative for varicella-zoster virus IgG antibodies at Screening
- Patients who have been treated with cladribine, cyclophosphamide or mitoxantrone at any time
- History of cardiovascular disorder
- Women of child-baring potential and inadequate contraception
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
Germany61 sites
Novartis Investigative Site
Aalen, 73430
Novartis Investigative Site
Abensberg, 93326
Novartis Investigative Site
Altenholz-Stift, Germany, 24161
Novartis Investigative Site
Alzenau in Unterfranken, 63755
Novartis Investigative Site
Andernach, Germany, 56626
Novartis Investigative Site
Aschaffenburg, 63739
Novartis Investigative Site
Bad Mergentheim, 97980
Novartis Investigative Site
Bamberg, 96052
Novartis Investigative Site
Berg, 82335
Novartis Investigative Site
Berlin, 10437
Novartis Investigative Site
Berlin, 10713
Novartis Investigative Site
Berlin, 12165
Novartis Investigative Site
Berlin, 13347
Novartis Investigative Site
Bielefeld, 33611
Novartis Investigative Site
Böblingen, 71032
Novartis Investigative Site
Bochum, 44787
Novartis Investigative Site
Bochum, 44789
Novartis Investigative Site
Bochum, 44791
Novartis Investigative Site
Bremen, 28755
Novartis Investigative Site
Celle, Germany, 29223
Novartis Investigative Site
Dortmund, Germany, 44135
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Düsseldorf, 40225
Novartis Investigative Site
Erbach im Odenwald, 64711
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Frankfurt, 60313
Novartis Investigative Site
Fulda, 36043
Novartis Investigative Site
Göttingen, Germany, 37073
Novartis Investigative Site
Grevenbroich, 41515
Novartis Investigative Site
Hamburg, 20249
Novartis Investigative Site
Hamburg, 22083
Novartis Investigative Site
Hennigsdorf, 16761
Novartis Investigative Site
Jena, 07740
Novartis Investigative Site
Kastellaun, Germany, 56288
Novartis Investigative Site
Kiel, Germany, 24105
Novartis Investigative Site
Klingenmünster, 76889
Novartis Investigative Site
Krefeld, Germany, 47800
Novartis Investigative Site
Lappersdorf, 93138
Novartis Investigative Site
Leipzig, Germany, 04299
Novartis Investigative Site
Leipzig, 04157
Novartis Investigative Site
Leverkusen, Germany, 51375
Novartis Investigative Site
Leverkusen, 51375
Novartis Investigative Site
Merzig, 66663
Novartis Investigative Site
Mönchengladbach, Germany, 41239
Novartis Investigative Site
München, 81829
Novartis Investigative Site
Neuburg am Inn, 86633
Novartis Investigative Site
Osnabrück, 49076
Novartis Investigative Site
Ostfildern, Baden-Wurttemberg, 73760
Novartis Investigative Site
Regensburg, 93053
Novartis Investigative Site
Schwendi, 88477
Novartis Investigative Site
Siegen, 57076
Novartis Investigative Site
Singen, 78224
Novartis Investigative Site
Stade, 21682
Novartis Investigative Site
Stadtroda, 07646
Novartis Investigative Site
Stuttgart, 70178
Novartis Investigative Site
Troisdorf, 53844
Novartis Investigative Site
Tübingen, 72076
Novartis Investigative Site
Ulm, 89073
Novartis Investigative Site
Unterhaching, 82008
Novartis Investigative Site
Wermsdorf, 04779
Novartis Investigative Site
Wolfenbüttel, 38300
About this study
Official title: A 6-month Multicenter, Single-arm, Open-label Study to Investigate Changes in Biomarkers After Initiation of Treatment With 0.5 mg Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
The purpose of this study is to investigate which changes in immunological biomarkers under treatment with fingolimod in patients with relapsing-remitting multiple sclerosis can be detected.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- Fingolimod
- Keywords
- Multiple sclerosis, RRMS, relapsing-remitting, fingolimod, biomarkers
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
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.
Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+)
Measured: 6 Months
Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+)
Measured: 6 months
Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-)
Measured: 6 months
Change from baseline of CD8+ central memory T cells (CCR7+CD45RA-)
Measured: 6 months
Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-)
Measured: 6 months
Secondary outcomes (3)
Change from baseline of B-lymphocytes
Measured: 6 months
Change from baseline of monocytes
Measured: 6 months
Change from baseline of Natural Killer cells
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2012
- Study completionJul 2012
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 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 447 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
- NCT01310166
- Sponsor's protocol ID
- CFTY720DDE01
- Other IDs
- 2010-022066-28
- Acronym
- Biobank
- Status last verified
- Nov 2016
- First submitted
- 24 Feb 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 6-month Multicenter, Single-arm, Open-label Study to Investigate Changes in Biomarkers After Initiation of Treatment With 0.5 mg Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01310166
- Acronym / sponsor ID
- Biobank / CFTY720DDE01
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Keywords
- Multiple sclerosis, RRMS, relapsing-remitting, fingolimod, biomarkers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Mar 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.
The purpose of this study is to investigate which changes in immunological biomarkers under treatment with fingolimod in patients with relapsing-remitting multiple sclerosis can be detected.
Study design
- Primary purpose
- Basic science
- 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 (2 listed)
- Subjects with relapsing forms of MS defined by 2005 revised McDonald criteria
- Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5
Key exclusion criteria (11 listed)
- Patients with a manifestation of MS other than relapsing remitting MS
- Patients with a history of chronic disease of the immune system other than MS such as known immunodeficiency syndrome
- History or presence of malignancy in the last 5 years
- Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients
- Diagnosis of macular edema during Screening Phase
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
Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+)
Time frame: 6 Months
Change from baseline of CD8+ naïve T cells (CCR7+CD45RA+)
Time frame: 6 months
Change from baseline of CD4+ central memory T cells (CCR7+CD45RA-)
Time frame: 6 months
Change from baseline of CD8+ central memory T cells (CCR7+CD45RA-)
Time frame: 6 months
Change from baseline of CD8+ effector memory T-cells (CCR7-CD45RA-)
Time frame: 6 months
3 secondary outcomes
Change from baseline of B-lymphocytes
Time frame: 6 months
Change from baseline of monocytes
Time frame: 6 months
Change from baseline of Natural Killer cells
Time frame: 6 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
61 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 Relapsing-remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 61 sites in Germany.
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 2 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: 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 61 sites in Germany. 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?
Change from baseline of Cluster of Differentiation (CD)4+ naive T cells (C-C Chemokine Receptor Type 7+(CCR7+CD45RA+) (time frame: 6 Months). The study lists 5 primary outcomes in all. 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.