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Multiple Sclerosis RelapsePhase 3TERACLESNCT01252355

Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta

A Phase 3 study testing Teriflunomide and Interferon-beta (IFN-beta) in people with Multiple Sclerosis Relapse, run by Sanofi at 185 sites in 28 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis Relapse
What is being tested?
Teriflunomide and Interferon-beta (IFN-beta)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
534 participants
Where
185 sitesin 28 countries
Study dates
Jan 2011to Apr 2013
Phase
Phase 3
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 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patient with relapsing forms of MS treated with IFN-beta
  • Stable dose of IFN-beta (approved brand) for at least 6 months prior to randomization
  • Disease activity in the 12 months prior to randomization and after first 3 months of IFN-beta treatment (defined by at least 1 relapse supported by EDSS or equivalent neurological examination, or, at least 1 brain or spinal cord MRI with at least one T1 gadolinium enhancing lesion)

Who cannot join

  • McDonald criteria for MS diagnosis not met at time of screening visit
  • EDSS score greater than (>) 5.5 at randomization visit
  • A relapse within 30 days prior randomization
  • Persistent significant or severe infection
  • Patients must not have used adrenocorticotrophic hormone or systemic corticosteroids for 2 weeks prior to randomization
  • Prior or concomitant use of cytokine therapy (except baseline interferons), glatiramer acetate or intravenous immunoglobulins in the 3 months preceding randomization
Show all 15Show fewer
  • Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2 times the upper limit of normal range (ULN)
  • Active hepatitis or hepatobiliary disease or known history of severe hepatitis
  • Pregnant or breast-feeding women or those who were planning to become pregnant during the study
  • Significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia
  • Human Immunodeficiency Virus (HIV) positive
  • Known history of active tuberculosis not adequately treated
  • Prior use within 2 years preceding randomization or concomitant use of cladribine and mitoxantrone
  • Prior use within 6 months preceding randomization or concomitant use of natalizumab, or any other immunosuppressive agents such as azathioprine, cyclophosphamide, cyclosporine, methotrexate, mycophenolate, or fingolimod
  • 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

185 sites in 28 countries.

185 sites in 28 countries

United States32 sites

  • Investigational Site Number 840023

    Albuquerque, New Mexico, 87131

  • Investigational Site Number 840041

    Baltimore, Maryland, 21201

  • Investigational Site Number 840028

    Baltimore, Maryland, 21287

  • Investigational Site Number 840006

    Bismarck, North Dakota, 58501

  • Investigational Site Number 840027

    Charlotte, North Carolina, 28204

  • Investigational Site Number 840034

    Chicago, Illinois, 60637

  • Investigational Site Number 840016

    Clinton Township, Michigan, 48035

  • Investigational Site Number 840005

    Cordova, Alaska, 38018

  • Investigational Site Number 840049

    Cullman, Alabama, 35058

  • Investigational Site Number 840046

    Dayton, Ohio, 45409

  • Investigational Site Number 840037

    Elk Grove Village, Illinois, 60007

  • Investigational Site Number 840007

    Fargo, North Dakota, 58103

  • Investigational Site Number 840036

    Fort Collins, Colorado, 80528

  • Investigational Site Number 840033

    Louisville, Kentucky, 40217

  • Investigational Site Number 840012

    Maitland, Florida, 32761

  • Investigational Site Number 840009

    Missoula, Montana, 59802

  • Investigational Site Number 840002

    Nashville, Tennessee, 37232

  • Investigational Site Number 840015

    New York, New York, 10029

  • Investigational Site Number 840011

    Oceanside, California, 92056

  • Investigational Site Number 840013

    Ormond Beach, Florida, 32174

  • Investigational Site Number 840003

    Phoenix, Arizona, 85060

  • Investigational Site Number 840055

    Pompano Beach, Florida, 33060

  • Investigational Site Number 840040

    Round Rock, Texas, 78681

  • Investigational Site Number 840020

    San Antonio, Texas, 78231

  • Investigational Site Number 840031

    St Louis, Missouri, 63104

  • Investigational Site Number 840030

    St Louis, Missouri, 63110

  • Investigational Site Number 840021

    St. Petersburg, Florida, 33713

  • Investigational Site Number 840004

    Tampa, Florida, 33609-4052

  • Investigational Site Number 840047

    Tampa, Florida, 33612

  • Investigational Site Number 840017

    Toledo, Ohio, 43699

  • Investigational Site Number 840043

    Tulsa, Oklahoma, 74137

  • Investigational Site Number 840032

    Vienna, Virginia, 22182

Other trials in United States

Germany23 sites

  • Investigational Site Number 276009

    Bad Mergentheim, 97980

  • Investigational Site Number 276020

    Bamberg, 96047

  • Investigational Site Number 276003

    Bayreuth, 95445

  • Investigational Site Number 276015

    Berlin, 10117

  • Investigational Site Number 276016

    Berlin, 10713

  • Investigational Site Number 276021

    Berlin, 12099

  • Investigational Site Number 276012

    Bonn, 53105

  • Investigational Site Number 276005

    Dresden, 01307

  • Investigational Site Number 276032

    Düsseldorf, 40211

  • Investigational Site Number 276018

    Erbach im Odenwald, 64711

  • Investigational Site Number 276004

    Erlangen, 91054

  • Investigational Site Number 276028

    Freiburg im Breisgau, 79098

  • Investigational Site Number 276006

    Giessen, 35385

  • Investigational Site Number 276010

    Hamburg, 20249

  • Investigational Site Number 276022

    Hennigsdorf, 16761

  • Investigational Site Number 276024

    Kassel, 34121

  • Investigational Site Number 276001

    Leipzig, 04103

  • Investigational Site Number 276013

    Mainz, 55131

  • Investigational Site Number 276023

    Minden, 32429

  • Investigational Site Number 276002

    Münster, 48149

  • Investigational Site Number 276031

    Rostock, 18055

  • Investigational Site Number 276008

    Wiesbaden, 65191

  • Investigational Site Number 276026

    Wuppertal, 42283

Other trials in Germany

Russia17 sites

  • Investigational Site Number 643012

    Kaluga, 248007

  • Investigational Site Number 643007

    Kazan', 420021

  • Investigational Site Number 643001

    Kemerovo, 650066

  • Investigational Site Number 643013

    Moscow, 129110

  • Investigational Site Number 643006

    Nizhny Novgorod, 603076

  • Investigational Site Number 643004

    Nizhny Novgorod, 603126

  • Investigational Site Number 643015

    Novosibirsk, 630007

  • Investigational Site Number 643010

    Rostov-on-Don, 344015

  • Investigational Site Number 643009

    Rostov-on-Don, 344022

  • Investigational Site Number 643011

    Saint Petersburg, 194044

  • Investigational Site Number 643018

    Saint Petersburg, 194291

  • Investigational Site Number 643003

    Saint Petersburg, 194354

  • Investigational Site Number 643017

    Saint Petersburg, 197089

  • Investigational Site Number 643002

    Saint Petersburg, 197376

  • Investigational Site Number 643016

    Samara, 443095

  • Investigational Site Number 643005

    Smolensk, 214019

  • Investigational Site Number 643014

    Yaroslavl, 150030

Other trials in Russia

Italy11 sites

  • Investigational Site Number 380009

    Catania, 95123

  • Investigational Site Number 380002

    Cefalù, 90015

  • Investigational Site Number 380003

    Fidenza, 43036

  • Investigational Site Number 380004

    Gallarate, 21013

  • Investigational Site Number 380012

    Montichiari, 25012

  • Investigational Site Number 380010

    Naples, 80131

  • Investigational Site Number 380011

    Naples, 80131

  • Investigational Site Number 380006

    Padova, 35128

  • Investigational Site Number 380005

    Roma, 00133

  • Investigational Site Number 380008

    Roma, 00161

  • Investigational Site Number 380014

    Verona, 37134

Other trials in Italy

Canada9 sites

  • Investigational Site Number 124005

    Calgary, T2N 2T9

  • Investigational Site Number 124004

    Edmonton, T6G 2G3

  • Investigational Site Number 124003

    Gatineau, J9J 0A5

  • Investigational Site Number 124006

    Kingston, K7L 2V7

  • Investigational Site Number 124007

    Montreal, H3A 2B4

  • Investigational Site Number 124008

    Ottawa, K1H 8L6

  • Investigational Site Number 124002

    Regina, S4T 1A5

  • Investigational Site Number 124001

    Sherbrooke, J1H 5N4

  • Investigational Site Number 124009

    Winnipeg, R3A 1R9

Other trials in Canada

Hungary8 sites

  • Investigational Site Number 348002

    Budapest, 1106

  • Investigational Site Number 348006

    Budapest, 1145

  • Investigational Site Number 348010

    Budapest, 1204

  • Investigational Site Number 348009

    Eger, 3300

  • Investigational Site Number 348003

    Esztergom, 2500

  • Investigational Site Number 348001

    Szeged, 6720

  • Investigational Site Number 348005

    Székesfehérvár, 8000

  • Investigational Site Number 348007

    Zalaegerszeg, 8900

Other trials in Hungary

Spain8 sites

  • Investigational Site Number 724001

    Barcelona, 08035

  • Investigational Site Number 724002

    Barcelona, 08036

  • Investigational Site Number 724009

    Córdoba, 14004

  • Investigational Site Number 724003

    Girona, 17007

  • Investigational Site Number 724004

    Madrid, 28005

  • Investigational Site Number 724005

    Madrid, 28040

  • Investigational Site Number 724007

    Murcia, 30120

  • Investigational Site Number 724008

    Seville, 41008

Other trials in Spain

Belgium7 sites

  • Investigational Site Number 056005

    Charleroi, 6000

  • Investigational Site Number 056004

    Ghent, 9000

  • Investigational Site Number 056003

    Hasselt, B-3590

  • Investigational Site Number 056006

    La Louvière, 7100

  • Investigational Site Number 056002

    Leuven, 3000

  • Investigational Site Number 056001

    Sijsele-Damme, 8340

  • Investigational Site Number 056007

    Wilrijk, 2610

Other trials in Belgium

France6 sites

  • Investigational Site Number 250003

    Besançon, 25030

  • Investigational Site Number 250010

    Clermont-Ferrand, 63003

  • Investigational Site Number 250002

    Lyon, 69394

  • Investigational Site Number 250004

    Montpellier, 34000

  • Investigational Site Number 250001

    Nancy, 54036

  • Investigational Site Number 250006

    Nantes, 44093

Other trials in France

United Kingdom6 sites

  • Investigational Site Number 826008

    Birmingham, B15 2TH

  • Investigational Site Number 826005

    Leeds, LS1 3EX

  • Investigational Site Number 826006

    Liverpool, L9 7LJ

  • Investigational Site Number 826003

    London, SW17 0QT

  • Investigational Site Number 826004

    Plymouth, PL6 8BX

  • Investigational Site Number 826001

    Salford, M6 8HD

Other trials in United Kingdom

Australia5 sites

  • Investigational Site Number 036008

    Bedford Park, 5042

  • Investigational Site Number 036005

    Chatswood, 2067

  • Investigational Site Number 036001

    Heidelberg West, 3081

  • Investigational Site Number 036004

    Kogarah, 2217

  • Investigational Site Number 036010

    New Lambton, 2305

Other trials in Australia

Brazil5 sites

  • Investigational Site Number 076009

    Joinville, 89202-165

  • Investigational Site Number 076012

    Passo Fundo, 99010-180

  • Investigational Site Number 076003

    Porto Alegre, 90020-090

  • Investigational Site Number 076007

    São Paulo, 04024-002

  • Investigational Site Number 076013

    São Paulo, 08270-070

Other trials in Brazil

Finland5 sites

  • Investigational Site Number 246003

    Helsinki, 00100

  • Investigational Site Number 246006

    Hyvinkää, 05800

  • Investigational Site Number 246004

    Oulu, 90220

  • Investigational Site Number 246002

    Pori, 28100

  • Investigational Site Number 246001

    Turku, 20100

Other trials in Finland

Colombia4 sites

  • Investigational Site Number 170001

    Barranquilla

  • Investigational Site Number 170005

    Bogotá

  • Investigational Site Number 170007

    Bogotá

  • Investigational Site Number 170009

    Medellín

Other trials in Colombia

Greece4 sites

  • Investigational Site Number 300002

    Athens, 11527

  • Investigational Site Number 300001

    Athens, 11535

  • Investigational Site Number 300003

    Heraklion, 71110

  • Investigational Site Number 300006

    Thessaloniki, 57010

Other trials in Greece

Netherlands4 sites

  • Investigational Site Number 528001

    Breda, 4818 CK

  • Investigational Site Number 528005

    Nieuwegein, 3435 CM

  • Investigational Site Number 528002

    Sittard-Geleen, 6162 BG

  • Investigational Site Number 528006

    Venray, 5801 CE

Other trials in Netherlands

Portugal4 sites

  • Investigational Site Number 620001

    Amadora, 2720-276

  • Investigational Site Number 620002

    Coimbra, 3000-075

  • Investigational Site Number 620004

    Coimbra, 3041-801

  • Investigational Site Number 620003

    Setúbal, 2910-446

Other trials in Portugal

Tunisia4 sites

  • Investigational Site Number 788002

    Manouba, 2010

  • Investigational Site Number 788005

    Monastir, 5000

  • Investigational Site Number 788004

    Sfax, 3029

  • Investigational Site Number 788006

    Tunis, 1008

Other trials in Tunisia

Argentina3 sites

  • Investigational Site Number 032002

    Argentina, 1426

  • Investigational Site Number 032003

    Buenos Aires

  • Investigational Site Number 032004

    Caba

Other trials in Argentina

Chile3 sites

  • Investigational Site Number 152003

    Santiago, 7500710

  • Investigational Site Number 152004

    Santiago, 838-0456

  • Investigational Site Number 152005

    Viña del Mar, 2570017

Other trials in Chile

Lithuania3 sites

  • Investigational Site Number 440002

    Kaunas, LT-50009

  • Investigational Site Number 440004

    Klaipėda, LT-92288

  • Investigational Site Number 440003

    Šiauliai, LT-76231

Other trials in Lithuania

South Korea3 sites

  • Investigational Site Number 410002

    Goyang-si, 410-760

  • Investigational Site Number 410004

    Seoul, 110-744

  • Investigational Site Number 410001

    Seoul, 136-705

Other trials in South Korea

Sweden3 sites

  • Investigational Site Number 752004

    Gothenburg, 413 45

  • Investigational Site Number 752003

    Stockholm, 14186

  • Investigational Site Number 752001

    Stockholm, 171 76

Other trials in Sweden

Austria2 sites

  • Investigational Site Number 040001

    Graz, 8036

  • Investigational Site Number 040004

    Linz, 4020

Other trials in Austria

Estonia2 sites

  • Investigational Site Number 233002

    Tallinn, 10617

  • Investigational Site Number 233001

    Tartu, 50406

Other trials in Estonia

Slovakia2 sites

  • Investigational Site Number 703002

    Martin, 03659

  • Investigational Site Number 703001

    Trnava, 91775

Other trials in Slovakia

Denmark1 site

  • Investigational Site Number 208002

    Aarhus C, 8000

Other trials in Denmark

Norway1 site

  • Investigational Site Number 578002

    Tønsberg, 3116

Other trials in Norway

About this study

Official title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis Who Are Treated With Interferon-beta

The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta).

The secondary objectives were:

  • Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on:
  • Disease activity as measured by brain Magnetic Resonance Imaging (MRI)
  • Disability progression
  • Burden of disease and disease progression as measured by brain MRI
  • Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy
  • Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy
  • Assess associations between variations in genes and clinical outcomes (safety and efficacy)
  • Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life
  • Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit)
Read the detailed description

The study period per patient was expected to be between 56 and 160 weeks depending on when the patient was randomized and this included the following:

  • a screening period up to 4 weeks,
  • a treatment period expected to be between 48 and 152 weeks,
  • 4-week post rapid elimination follow-up period.

Patients were to continue on treatment until a fixed common end date which was approximately 48 weeks after randomization of the last patient.

For those patients who completed the treatment period, a long term extension study of approximately 1 year (including teriflunomide alone) was initially planned to be proposed.

Being tested
Teriflunomide, Placebo (for teriflunomide), Interferon-beta (IFN-beta)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TeriflunomideDrug

    Also called HMR1726

    Film-coated tablet

    Oral administration

  • Placebo (for teriflunomide)Drug

    Film-coated tablet

    Oral administration

  • Interferon-beta (IFN-beta)Drug

    Any of the IFN-beta which are approved for marketed use in the country where the patient is enrolled.

    Administration according to the package insert.

Study groups in NCT01252355
Study groupRoleWhat they receive
Teriflunomide 7 mg + IFN-betaExperimentalTeriflunomide 7 milligram (mg) once a day concomitantly with IFN-beta therapy.
Receives: Drug: Teriflunomide; Drug: Interferon-beta (IFN-beta)
Teriflunomide 14 mg + IFN-betaExperimentalTeriflunomide 14 mg once a day concomitantly with IFN-beta therapy.
Receives: Drug: Teriflunomide; Drug: Interferon-beta (IFN-beta)
Placebo + IFN-betaPlacebo comparatorPlacebo (for teriflunomide) once a day concomitantly with IFN-beta therapy.
Receives: Drug: Placebo (for teriflunomide); Drug: Interferon-beta (IFN-beta)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized Relapse Rate (ARR) (Poisson Regression Estimates)

    ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as "offset" variable; treatment group, region of enrollment and IFN-beta dose stratum, and number of relapses in the year prior to randomization as covariates).

    Measured: Up to a maximum of 108 weeks depending on time of enrollment

Secondary outcomes (9)

  1. Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per Scan (Poisson Regression Estimates)

    Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment, IFN-beta dose stratum and baseline number of Gd-enhancing T1-lesions as covariates).

    Measured: Up to a maximum of 108 weeks depending on time of enrollment

  2. Time to 12-Week Sustained Disability Progression

    The 12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks. Probability of disability progression was to be estimated using Kaplan-Meier method.

    Measured: Up to a maximum of 108 weeks depending on time of enrollment

  3. Brain MRI Assessment: Volume of Gd-enhancing T1-lesions Per MRI Scan

    Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period.

    Measured: Up to a maximum of 108 weeks depending on time of enrollment

  4. Brain MRI Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) at Week 24

    The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, region, IFN-beta dose stratum, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.

    Measured: Baseline, Week 24

  5. Time to Relapse: Kaplan-Meier Estimates of the Probability of no Relapse at Week 24, 48, and 72

    Probability of no relapse at 24, 48 and 72 weeks was estimated using Kaplan-Meier method on the time to relapse defined as the time from randomization to first EDSS confirmed relapse. Participants free of confirmed relapse (no EDSS confirmed relapse observed on treatment) were censored at the date of the last study drug intake. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time <=t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.

    Measured: Up to a maximum of 108 weeks depending on time of enrollment

  6. Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 24

    FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS.

    Measured: Baseline, Week 24

  7. Change From Baseline in Short Form Generic Health Survey - 36 Items, Version 2 (SF-36v2) Summary Scores at Week 24

    SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument.

    Measured: Baseline, Week 24

  8. Resource Utilization When Relapse

    Resource utilization each time a participant experiences an MS relapse, specifically the number of hospitalizations, the number of over night spent in the hospital and number of intensive care admissions if hospitalized were to be reported.

    Measured: Up to a maximum of 108 weeks depending on time of enrollment

  9. Overview of Adverse Events (AEs)

    AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.

    Measured: First study drug intake up to 28 days after last study drug intake, for up to 112 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionApr 2013
  4. Study completionApr 2013

Why it stopped: Sponsor decision to prematurely stop the study, not linked to any safety concern.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
534 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01252355
Sponsor's protocol ID
EFC6058
Other IDs
2010-023172-12, U1111-1115-2414
Acronym
TERACLES
Status last verified
May 2014
First submitted
30 Nov 2010
Last updated
9 Jun 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Teriflunomide and Interferon-beta (IFN-beta) in people with Multiple Sclerosis Relapse, run by Sanofi at 185 sites in 28 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 3 inclusion and 15 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 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 185 sites in United States, Germany, Russia, Italy, Canada and 23 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 22 May 2014). 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?

Annualized Relapse Rate (ARR) (Poisson Regression Estimates) (time frame: Up to a maximum of 108 weeks depending on time of enrollment). 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 NCT01252355.

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 9 Jun 2014.

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