Multiple SclerosisPhase 4NCT03364036
Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)
A Phase 4 study testing Mavenclad® in people with Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 54 sites in 14 countries.
Trial summary
The main purpose of the study was to determine the onset of Mavenclad® action by frequent magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in participants with highly active relapsing multiple sclerosis (MS). 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?
- Mavenclad®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 54 sitesin 14 countries
- Study dates
- 28 May 2018to 21 Feb 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Highly active RMS as defined by:
- One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs)
- Two or more relapses in the previous year, whether on DMD treatment or not.
- Expanded Disability Status Scale (EDSS) score less than equals to (<=) 5.0.
- Other protocol defined inclusion criteria could apply.
Who cannot join
- Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab.
- Positive hepatitis C or hepatitis B surface antigen test and/or hepatits B core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM).
- Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result.
- Currently receiving immunosuppressive or myelosuppressive therapy with, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids.
- History of tuberculosis , presence of active tuberculosis, or latent tuberculosis
- Evidence or suspect of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI).
- Active malignancy or history of malignancy.
- Other protocol defined exclusion criteria could apply.
Trial locations and contacts
54 sites in 14 countries.
54 sites in 14 countries
Germany8 sites
Universitätsklinikum Bonn
Bonn, 53105
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
Neuro Centrum Science GmbH
Erbach im Odenwald
Universitätsklinikum Essen
Essen
Neurologische Praxis Eppendorf
Hamburg
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum Leipzig
Leipzig, 04103
Universitätsklinikum Münster
Münster, 48149
France7 sites
CHRU de Lille
Lille, 59037
CHU Nice - Hôpital Pasteur
Nice, 06002
CHU Montpellier-Nîmes - Hôpital Caremeau
Nîmes, 30004
CHU Nîmes
Nîmes, 30029
CHU de Poissy
Poissy, 78303
CHU de Pontchaillou
Rennes, Ille Et Vilaine, 35033
Hôpital Civil
Strasbourg, 67091
Czechia5 sites
Fakultni nemocnice u sv. Anny v Brne
Brno, 65691
Fakultni nemocnice Brno
Brno-Bohunice, Brno-Bohunice, 630 00
FN Hradec Kralove
Choceň, 56501
Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
Pardubice, Pardubice Region, 532 03
Fakultni nemocnice v Motole
Prague, 15006
Spain5 sites
Hospital de Cruces
Baracaldo Vizcaya, Vizcaya, 48903
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, 28035
Hospital Clinico San Carlos
Madrid, 28046
Hospital Vithas NISA Sevilla
Seville, 41009
Hospital La Fe
Valencia, 46009
Australia4 sites
John Hunter Hospital
Hunter Region Mail Centre, 2310-2305
Perron Institute - Neurology
Nedlands, 6009
The Alfred Hospital
Prahran, 3181
Liverpool Hospital
Sydney, New South Wales, 2170
Canada4 sites
University of Alberta
Edmonton, T6G 2G3
UB - State University of New York
London, Ontario, N6A 5A5
Montreal Neurological Hospital
Montreal, H3A 2B4
MS Clinical Trials Group
Vancouver, British Columbia, V6T 1Z3
Italy4 sites
Policlinico Universitario SS Annunziata
Chieti
Seconda Univesità degli Studi di Napoli, AOU
Naples, 80131
IRCSS Neuromed Istituto Neurologico Mediterraneo
Roma, 133
Universita di SIENA
Siena, 53100
Finland3 sites
Helsinki University Central Hospital
Helsinki
FinnMedi Oy vastaanotto - Finn-Medi 3
Tampere, 33520
Turku University Hospital
Turku, 20521
Israel3 sites
Barzilai Medical Center
Ashkelon, 78306
Rambam MC
Haifa, 31096
The Chaim Sheba Medical Center
Tel HaShomer, 52621
Poland3 sites
Samodzielny Publiczny Szpital Kliniczny nr 7 SUM
Katowice, 40-662
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
Lublin, Lublin Voivodeship, 20-954
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach
Zabrze, 41-800
United Kingdom3 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
University Hospital of Wales
Cardiff, Wales, CF14 4XN
Sheffield Teaching Hospitals Sheffield
Sheffield, SI0 2JF
Austria2 sites
Klagenfurt1
Klagenfurt, 9020
Paracelsus Medical University Salzburg
Salzburg, 5020
Sweden2 sites
Sahlgrenska Universitetssjukhus
Gothenburg, 416 85
Akademiskt Specialist Centrum - Centrum för Neurologi, plan 5
Stockholm, 171 76
Hungary1 site
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
Szeged, 6701
About this study
Official title: A 2-year Prospective Study to Evaluate the Onset of Action of Mavenclad® in Subjects With Highly Active Relapsing Multiple Sclerosis (MAGNIFY)
The main purpose of the study was to determine the onset of Mavenclad® action by frequent magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in participants with highly active relapsing multiple sclerosis (MS).
- Conditions
- Multiple Sclerosis
- Being tested
- Mavenclad®
- Keywords
- Multiple sclerosis, Mavenclad ®, Cladribine
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mavenclad®Drug
Also called Cladribine
Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
| Study group | Role | What they receive |
|---|---|---|
| Mavenclad® | Experimental | Not described Receives: Drug: Mavenclad® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 1 (Month 1-6)
CUA lesions were measured by using MRI scans.
Measured: Baseline period (the period screening to Baseline), Period 1 (Month 1-6)
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 2 (Month 2-6)
CUA lesions were measured by using MRI scans.
Measured: Baseline period (the period screening to Baseline), Period 2 (Month 2-6)
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 3 (Month 3-6)
CUA lesions were measured by using MRI scans.
Measured: Baseline period (the period screening to Baseline), Period 3 (Month 3-6)
Secondary outcomes (3)
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
B cell population counts are: CD19 B cells (TBNK panel), CD20 B cells (B cell panel), Memory B cells (B cell panel), Activated B cells (B cell panel), Total plasma cells (B cell panel), Short-lived plasma cells (B cell panel), Naïve B cells (B cell panel), Transitional B cells (B cell panel), and Regulatory B cells (B cell panel).
Measured: Baseline, Month 3, 6, 12, 15, 18 and 24
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
T cell population counts are: Total CD4 T cells (TBNK panel), CD4 Th1 cells (T cell panel), CD4 Th17 T cells (T cell panel), CD4 Regulatory T cells (T cell panel), and Total CD8 T cells (TBNK panel).
Measured: Baseline, Month 3, 6, 12, 15, 18 and 24
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
NK cell population counts are: CD16+ CD56+ NK Cells, CD16+ NK Cells, NK p46 cells, CD16lowCD56bright, and CD16brightCD56dim.
Measured: Baseline, Month 3, 6, 12, 15, 18 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start28 May 2018
- Primary completion5 May 2020
- Study completion21 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364036
- Sponsor's protocol ID
- MS700568_0022
- Other IDs
- 2017-002631-42, 2017
- Status last verified
- Feb 2023
- First submitted
- 1 Dec 2017
- Last updated
- 16 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Stefano N, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Schmierer K, Sellebjerg F, Vermersch P, Wiendl H, Keller B, Roy S; MAGNIFY-MS Study Group. Early Reduction of MRI Activity During 6 Months of Treatment With Cladribine Tablets for Highly Active Relapsing Multiple Sclerosis: MAGNIFY-MS. Neurol Neuroimmunol Neuroinflamm. 2022 Jun 14;9(4):e1187. doi: 10.1212/NXI.0000000000001187. Print 2022 Jul.
PubMed 35701185Schmierer K, Wiendl H, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Sellebjerg F, Vermersch P, Jin H, Sponton L, Chudecka A, Bucello M, Gardner L, De Stefano N. A plain language summary on clinical and mechanistic effects of cladribine in relapsing multiple sclerosis: 2-year results from the MAGNIFY-MS study. Neurodegener Dis Manag. 2026 Apr 6:1-11. doi: 10.1080/17582024.2026.2646302. Online ahead of print.
PubMed 41943490Schmierer K, Wiendl H, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Sellebjerg F, Vermersch P, Jin H, Sponton L, Chudecka A, Gardner L, De Stefano N. Clinical and mechanistic effects of cladribine in relapsing multiple sclerosis: 2-year results from the MAGNIFY-MS Study. Ther Adv Neurol Disord. 2025 Jul 31;18:17562864251351760. doi: 10.1177/17562864251351760. eCollection 2025.
PubMed 40756532Wiendl H, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Schmierer K, Sellebjerg F, Vermersch P, Jin H, Chudecka A, Kloetgen A, Lin D, Gardner L, De Stefano N. Blood biomarker dynamics in people with relapsing multiple sclerosis treated with cladribine tablets: results of the 2-year MAGNIFY-MS study. Front Immunol. 2025 Feb 3;16:1512189. doi: 10.3389/fimmu.2025.1512189. eCollection 2025.
PubMed 39963134Wiendl H, Schmierer K, Hodgkinson S, Derfuss T, Chan A, Sellebjerg F, Achiron A, Montalban X, Prat A, De Stefano N, Barkhof F, Leocani L, Vermersch P, Chudecka A, Mwape C, Holmberg KH, Boschert U, Roy S; MAGNIFY-MS Study Group. Specific Patterns of Immune Cell Dynamics May Explain the Early Onset and Prolonged Efficacy of Cladribine Tablets: A MAGNIFY-MS Substudy. Neurol Neuroimmunol Neuroinflamm. 2022 Nov 21;10(1):e200048. doi: 10.1212/NXI.0000000000200048. Print 2023 Jan.
PubMed 36411081Schmierer K, Wiendl H, Oreja-Guevara C, Centonze D, Chudecka A, Roy S, Boschert U. Varicella zoster virus and influenza vaccine antibody titres in patients from MAGNIFY-MS who were treated with cladribine tablets for highly active relapsing multiple sclerosis. Mult Scler. 2022 Nov;28(13):2151-2153. doi: 10.1177/13524585221099413. Epub 2022 Jun 7. No abstract available.
PubMed 35672923
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-year Prospective Study to Evaluate the Onset of Action of Mavenclad® in Subjects With Highly Active Relapsing Multiple Sclerosis (MAGNIFY)
- ClinicalTrials.gov ID
- NCT03364036
- Acronym / sponsor ID
- MS700568_0022
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Mavenclad ®, Cladribine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 28 May 2018 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Posted 27 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study was to determine the onset of Mavenclad® action by frequent magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in participants with highly active relapsing multiple sclerosis (MS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mavenclad® | Experimental | Drug: Mavenclad® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Highly active RMS as defined by:
- One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs)
- Two or more relapses in the previous year, whether on DMD treatment or not.
- Expanded Disability Status Scale (EDSS) score less than equals to (<=) 5.0.
- Other protocol defined inclusion criteria could apply.
Key exclusion criteria (8 listed)
- Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab.
- Positive hepatitis C or hepatitis B surface antigen test and/or hepatits B core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM).
- Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result.
- Currently receiving immunosuppressive or myelosuppressive therapy with, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids.
- History of tuberculosis , presence of active tuberculosis, or latent tuberculosis
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 |
|---|---|---|
| Mavenclad®Also: CladribineParticipants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year. | Drug | Mavenclad® |
Primary outcome
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 1 (Month 1-6)
Time frame: Baseline period (the period screening to Baseline), Period 1 (Month 1-6)
CUA lesions were measured by using MRI scans.
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 2 (Month 2-6)
Time frame: Baseline period (the period screening to Baseline), Period 2 (Month 2-6)
CUA lesions were measured by using MRI scans.
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 3 (Month 3-6)
Time frame: Baseline period (the period screening to Baseline), Period 3 (Month 3-6)
CUA lesions were measured by using MRI scans.
3 secondary outcomes
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Time frame: Baseline, Month 3, 6, 12, 15, 18 and 24
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Time frame: Baseline, Month 3, 6, 12, 15, 18 and 24
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
Time frame: Baseline, Month 3, 6, 12, 15, 18 and 24.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35701185de Stefano N, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Schmierer K, Sellebjerg F, Vermersch P, Wiendl H, Keller B, Roy S; MAGNIFY-MS Study Group. Early Reduction of MRI Activity During 6 Months of Treatment With Cladribine Tablets for Highly Active Relapsing Multiple Sclerosis: MAGNIFY-MS. Neurol Neuroimmunol Neuroinflamm. 2022 Jun 14;9(4):e1187. doi: 10.1212/NXI.0000000000001187. Print 2022 Jul.
- Derived from this study: PubMed 41943490Schmierer K, Wiendl H, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Sellebjerg F, Vermersch P, Jin H, Sponton L, Chudecka A, Bucello M, Gardner L, De Stefano N. A plain language summary on clinical and mechanistic effects of cladribine in relapsing multiple sclerosis: 2-year results from the MAGNIFY-MS study. Neurodegener Dis Manag. 2026 Apr 6:1-11. doi: 10.1080/17582024.2026.2646302. Online ahead of print.
- Derived from this study: PubMed 40756532Schmierer K, Wiendl H, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Sellebjerg F, Vermersch P, Jin H, Sponton L, Chudecka A, Gardner L, De Stefano N. Clinical and mechanistic effects of cladribine in relapsing multiple sclerosis: 2-year results from the MAGNIFY-MS Study. Ther Adv Neurol Disord. 2025 Jul 31;18:17562864251351760. doi: 10.1177/17562864251351760. eCollection 2025.
- Derived from this study: PubMed 39963134Wiendl H, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Schmierer K, Sellebjerg F, Vermersch P, Jin H, Chudecka A, Kloetgen A, Lin D, Gardner L, De Stefano N. Blood biomarker dynamics in people with relapsing multiple sclerosis treated with cladribine tablets: results of the 2-year MAGNIFY-MS study. Front Immunol. 2025 Feb 3;16:1512189. doi: 10.3389/fimmu.2025.1512189. eCollection 2025.
- Derived from this study: PubMed 36411081Wiendl H, Schmierer K, Hodgkinson S, Derfuss T, Chan A, Sellebjerg F, Achiron A, Montalban X, Prat A, De Stefano N, Barkhof F, Leocani L, Vermersch P, Chudecka A, Mwape C, Holmberg KH, Boschert U, Roy S; MAGNIFY-MS Study Group. Specific Patterns of Immune Cell Dynamics May Explain the Early Onset and Prolonged Efficacy of Cladribine Tablets: A MAGNIFY-MS Substudy. Neurol Neuroimmunol Neuroinflamm. 2022 Nov 21;10(1):e200048. doi: 10.1212/NXI.0000000000200048. Print 2023 Jan.
- Derived from this study: PubMed 35672923Schmierer K, Wiendl H, Oreja-Guevara C, Centonze D, Chudecka A, Roy S, Boschert U. Varicella zoster virus and influenza vaccine antibody titres in patients from MAGNIFY-MS who were treated with cladribine tablets for highly active relapsing multiple sclerosis. Mult Scler. 2022 Nov;28(13):2151-2153. doi: 10.1177/13524585221099413. Epub 2022 Jun 7. No abstract available.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
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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.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
54 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mavenclad® in people with Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 54 sites in 14 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 5 inclusion and 8 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 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Germany, France, Czechia, Spain, Australia and 9 more countries. 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?
Yes. Results are posted in the registry (first posted 27 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 1 (Month 1-6) (time frame: Baseline period (the period screening to Baseline), Period 1 (Month 1-6)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03364036, which also lists 6 linked publications.
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 16 Mar 2023.