Multiple SclerosisPhase 3TENERENCT00883337
A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis
A Phase 3 study testing Interferon β-1a and Teriflunomide in people with Multiple Sclerosis, run by Sanofi at 54 sites in 13 countries.
Trial summary
Primary objective was to assess the effectiveness evaluated by the time to failure of two doses of teriflunomide in comparison to interferon beta-1a in participants with 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?
- Interferon β-1a and Teriflunomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 54 sitesin 13 countries
- Study dates
- Apr 2009to May 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsing form of MS meeting McDonald's criteria for MS diagnosis and Expanded Disability Status Scale [EDSS] score ≤5.5 at screening visit.
Who cannot join
- Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia;
- Persistent significant or severe infection.
- Liver function impairment or known history of hepatitis.
- Use of adrenocorticotrophic hormone [ACTH] or systemic corticosteroids for 2 weeks prior to randomization.
- Human immunodeficiency virus [HIV] positive.
- Prior use of Rebif®, or prior or concomitant use of other interferons in the 3 months prior to randomization.
Show all 15Show fewer
- Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, or natalizumab.
- Pregnant or breast-feeding woman.
- Extension criteria:
- The participants who met all the following criteria at the end of the core study period were eligible for enrolment into the open-label extension phase:
- Participants who had not discontinued treatment in the core period and who had a minimum treatment of 48 weeks and completed the EOT visit (Visit 18).
- Participants who had not met criteria for treatment withdrawal.
- An informed consent must be obtained in writing from the participant for this open-label extension phase prior to entering and prior to completion of any extension phase procedure.
- Participants who demonstrated a willingness and ability to roll over to the extension phase with the opportunity to continue treatment on 14 mg/day of teriflunomide under open-label.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
54 sites in 13 countries.
54 sites in 13 countries
Germany11 sites
Investigational Site Number 276003
Bad Mergentheim, 97980
Investigational Site Number 276011
Berlin, 10117
Investigational Site Number 276012
Berlin, 12099
Investigational Site Number 276001
Bochum, 44791
Investigational Site Number 276005
Dresden, 01307
Investigational Site Number 276007
Erbach im Odenwald, 64711
Investigational Site Number 276006
Essen, 45138
Investigational Site Number 276004
Halle, 06120
Investigational Site Number 276010
Hanover, 30559
Investigational Site Number 276009
Mainz, 55131
Investigational Site Number 276002
Münster, 48149
Italy9 sites
Investigational Site Number 380010
Ancona, 60020
Investigational Site Number 380005
Bari, 70124
Investigational Site Number 380008
Cagliari, 09126
Investigational Site Number 380003
Cefalù, 90015
Investigational Site Number 380007
Genova, 16132
Investigational Site Number 380001
Milan, 20132
Investigational Site Number 380004
Pavia, 27100
Investigational Site Number 380002
Roma, 00185
Investigational Site Number 380006
Torino, 10126
Hungary6 sites
Investigational Site Number 348001
Budapest, 1083
Investigational Site Number 348005
Budapest, 1096
Investigational Site Number 348003
Budapest, 1106
Investigational Site Number 348002
Esztergom, 2500
Investigational Site Number 348007
Kecskemét, 6000
Investigational Site Number 348004
Veszprém, 8200
France5 sites
Investigational Site Number 250003
Bordeaux, 33076
Investigational Site Number 250005
Clermont-Ferrand, 63003
Investigational Site Number 250004
Lille, 59037
Investigational Site Number 250001
Montpellier, 34000
Investigational Site Number 250002
Strasbourg, 67091
Poland4 sites
Investigational Site Number 616002
Bialystok, 15-276
Investigational Site Number 616004
Gdansk, 80-803
Investigational Site Number 616003
Lublin, 20-718
Investigational Site Number 616001
Warsaw, 02-957
Spain4 sites
Investigational Site Number 724007
Barcelona, 08036
Investigational Site Number 724001
Bilbao, 48013
Investigational Site Number 724002
Majadahonda, 28222
Investigational Site Number 724003
Murcia, 30120
Belgium3 sites
Investigational Site Number 056003
Brussels, 1070
Investigational Site Number 056001
Ghent, 9000
Investigational Site Number 056002
Hasselt, B-3590
Canada3 sites
Investigational Site Number 124003
Lévis, G6V 3Z1
Investigational Site Number 124002
London, N6A 5A5
Investigational Site Number 124004
St. John's, A1B 3V6
Czechia3 sites
Investigational Site Number 203004
Jihlava, 58633
Investigational Site Number 203003
Prague, 10034
Investigational Site Number 203002
Prague, 12808
Greece2 sites
Investigational Site Number 300001
Athens, 11527
Investigational Site Number 300002
Thessaloniki
United Kingdom2 sites
Investigational Site Number 826002
London, SW17 0QT
Investigational Site Number 826003
Plymouth, PL6 5BX
About this study
Official title: A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension Period
Primary objective was to assess the effectiveness evaluated by the time to failure of two doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing Multiple Sclerosis [MS].
Secondary objectives were:
Read more
- To assess the effect of the two doses in comparison to interferon beta-1a on:
- Frequency of relapses,
- Fatigue,
- Participant's satisfaction with treatment.
- To evaluate the safety and tolerability of the two doses in comparison to interferon beta-1a.
The study consisted of a core treatment period with a common end date defined as 48 weeks after randomization of the last participant, followed by an optional long-term extension treatment period until teriflunomide is commercially available in accordance with local regulations.
Read the detailed description
The core treatment period per participant was variable depending on the enrollment in the study (maximum of approximatively 118 weeks). The two doses of teriflunomide were administered in double-blind fashion, whereas interferon beta-1a (Rebif®) was open-label.
The opportunity to continue with the highest dose of teriflunomide in open-label fashion was offered to the participants who successfully completed treatment in the core study.
The overall treatment period was followed by a 4-week elimination follow-up period.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon β-1a, Teriflunomide
- Keywords
- Relapsing-remitting multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon β-1aDrug
Also called Rebif®
Sterile preservative-free solution packaged in graduated pre-filled syringes
Subcutaneous injection
Ascending doses from 8.8 to 44 mcg according to local standard for Rebif®
TeriflunomideDrug
Also called HMR1726
Film-coated tablet
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Teriflunomide 7 mg / 14 mg | Experimental | Teriflunomide 7 mg once daily (core treatment period) and teriflunomide 14 mg once daily (extended treatment period). Receives: Drug: Teriflunomide |
| Teriflunomide 14 mg / 14 mg | Experimental | Teriflunomide 14 mg once daily (core treatment period) and teriflunomide 14 mg once daily (extension treatment period). Receives: Drug: Teriflunomide |
| IFN-β-1a / 14 mg | Active comparator | Interferon β-1a 3 times a week (core treatment period) and teriflunomide 14 mg once daily (extended treatment period). Receives: Drug: Interferon β-1a; Drug: Teriflunomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Treatment Period: Overview of Failures
Failure was defined as the first occurence of confirmed relapse or permanent treatment discontinuation (for any cause) which ever came first. If no events occurred, the participant was considered free of failure.
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.
Measured: Core treatment period between 48 and 118 weeks depending on when the participant was enrolled
Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints
Probability of disability progression at 24, 48 and 96 weeks was estimated using Kaplan-Meier method on the time to failure defined as the time from randomization to failure. Participants free of failure were censored at the date of last treatment.
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. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t.
Measured: Core treatment period between 48 and 118 weeks depending on when the participant was enrolled
Secondary outcomes (6)
Core Treatment Period: Annualized Relapse Rate [ARR] - Poisson Regression Estimates
ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.
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 baseline EDSS stratum as covariates).
Measured: Core treatment period between 48 and 118 weeks depending on when the participant was enrolled
Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score
FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in patients with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social.
FIS total score ranges from 0 (no problem) to 160 (extreme problem).
Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors).
Measured: Baseline (before randomization) and 48 weeks
Core Treatment Period: Treatment Satisfaction Questionnaire for Medication [TSQM] Scores
TSQM version 1.4 is an instrument to assess patients' satisfaction with medication. It consists of 13 questions that cover three dimensions (effectiveness, side effects and convenience) plus a global satisfaction question. Four scores ranging from 0 to 100 (extremely satisfied) are obtained. Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on TSQM score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction as factors).
Measured: 48 weeks
Core Treatment Period: Overview of Adverse Events [AE]
AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
Measured: from first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first
Extension Treatment Period: Overview of AEs
AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
Measured: From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period
Extension Treatment Period: ARR Poisson Regression Estimates
ARR was obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of the standardized treatment durations.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 enrolment and baseline EDSS stratum as covariates).
Measured: Extension treatment period (Maximum: 197 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2011
- Study completionMay 2015
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 (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883337
- Sponsor's protocol ID
- EFC10891
- Other IDs
- 2008-006226-34, 2008
- Acronym
- TENERE
- Status last verified
- May 2016
- First submitted
- 16 Apr 2009
- Last updated
- 13 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vermersch P, Czlonkowska A, Grimaldi LM, Confavreux C, Comi G, Kappos L, Olsson TP, Benamor M, Bauer D, Truffinet P, Church M, Miller AE, Wolinsky JS, Freedman MS, O'Connor P; TENERE Trial Group. Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial. Mult Scler. 2014 May;20(6):705-16. doi: 10.1177/1352458513507821. Epub 2013 Oct 14.
PubMed 24126064Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.
PubMed 33023488
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension Period
- ClinicalTrials.gov ID
- NCT00883337
- Acronym / sponsor ID
- TENERE / EFC10891
- Conditions
- Multiple Sclerosis
- Keywords
- Relapsing-remitting multiple sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Posted 6 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective was to assess the effectiveness evaluated by the time to failure of two doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing Multiple Sclerosis [MS].
Secondary objectives were:
- To assess the effect of the two doses in comparison to interferon beta-1a on:
- Frequency of relapses,
- Fatigue,
- Participant's satisfaction with treatment.
- To evaluate the safety and tolerability of the two doses in comparison to interferon beta-1a.
The study consisted of a core treatment period with a common end date defined as 48 weeks after randomization of the last participant, followed by an optional long-term extension treatment period until teriflunomide is commercially available in accordance with local regulations.
Detailed description
The core treatment period per participant was variable depending on the enrollment in the study (maximum of approximatively 118 weeks). The two doses of teriflunomide were administered in double-blind fashion, whereas interferon beta-1a (Rebif®) was open-label.
The opportunity to continue with the highest dose of teriflunomide in open-label fashion was offered to the participants who successfully completed treatment in the core study.
The overall treatment period was followed by a 4-week elimination follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Teriflunomide 7 mg / 14 mg | Experimental | Drug: TeriflunomideTeriflunomide 7 mg once daily (core treatment period) and teriflunomide 14 mg once daily (extended treatment period). |
| Teriflunomide 14 mg / 14 mg | Experimental | Drug: TeriflunomideTeriflunomide 14 mg once daily (core treatment period) and teriflunomide 14 mg once daily (extension treatment period). |
| IFN-β-1a / 14 mg | Active comparator | Drug: Interferon β-1a, Drug: TeriflunomideInterferon β-1a 3 times a week (core treatment period) and teriflunomide 14 mg once daily (extended treatment period). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Relapsing form of MS meeting McDonald's criteria for MS diagnosis and Expanded Disability Status Scale [EDSS] score ≤5.5 at screening visit.
Key exclusion criteria (15 listed)
- Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia;
- Persistent significant or severe infection.
- Liver function impairment or known history of hepatitis.
- Use of adrenocorticotrophic hormone [ACTH] or systemic corticosteroids for 2 weeks prior to randomization.
- Human immunodeficiency virus [HIV] positive.
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 |
|---|---|---|
| Interferon β-1aAlso: Rebif®Sterile preservative-free solution packaged in graduated pre-filled syringes Subcutaneous injection Ascending doses from 8.8 to 44 mcg according to local standard for Rebif® | Drug | IFN-β-1a / 14 mg |
| TeriflunomideAlso: HMR1726Film-coated tablet Oral administration | Drug | IFN-β-1a / 14 mg, Teriflunomide 14 mg / 14 mg, Teriflunomide 7 mg / 14 mg |
Primary outcome
Core Treatment Period: Overview of Failures
Time frame: Core treatment period between 48 and 118 weeks depending on when the participant was enrolled
Failure was defined as the first occurence of confirmed relapse or permanent treatment discontinuation (for any cause) which ever came first. If no events occurred, the participant was considered free of failure. 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.
Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints
Time frame: Core treatment period between 48 and 118 weeks depending on when the participant was enrolled
Probability of disability progression at 24, 48 and 96 weeks was estimated using Kaplan-Meier method on the time to failure defined as the time from randomization to failure. Participants free of failure were censored at the date of last treatment. 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. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t.
6 secondary outcomes
Core Treatment Period: Annualized Relapse Rate [ARR] - Poisson Regression Estimates
Time frame: Core treatment period between 48 and 118 weeks depending on when the participant was enrolled
Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score
Time frame: Baseline (before randomization) and 48 weeks
Core Treatment Period: Treatment Satisfaction Questionnaire for Medication [TSQM] Scores
Time frame: 48 weeks
Core Treatment Period: Overview of Adverse Events [AE]
Time frame: from first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first
Extension Treatment Period: Overview of AEs
Time frame: From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period
Extension Treatment Period: ARR Poisson Regression Estimates
Time frame: Extension treatment period (Maximum: 197 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24126064Vermersch P, Czlonkowska A, Grimaldi LM, Confavreux C, Comi G, Kappos L, Olsson TP, Benamor M, Bauer D, Truffinet P, Church M, Miller AE, Wolinsky JS, Freedman MS, O'Connor P; TENERE Trial Group. Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial. Mult Scler. 2014 May;20(6):705-16. doi: 10.1177/1352458513507821. Epub 2013 Oct 14.
- Derived from this study: PubMed 33023488Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
Clinical Sciences & Operations study director
Sanofi
54 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interferon β-1a and Teriflunomide in people with Multiple Sclerosis, run by Sanofi at 54 sites in 13 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 1 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: finished, as of the sponsor's last update on 13 Jun 2016. 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, Italy, Hungary, France, Poland and 8 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 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 6 Nov 2012). 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?
Core Treatment Period: Overview of Failures (time frame: Core treatment period between 48 and 118 weeks depending on when the participant was enrolled). The study lists 2 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 NCT00883337, which also lists 2 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 13 Jun 2016.