Rheumatoid ArthritisPhase 2NCT01217814
Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers
A Phase 2 study testing Sarilumab, Golimumab and methotrexate (MTX) in people with Rheumatoid Arthritis, run by Sanofi at 14 sites in 6 countries.
Trial summary
Primary Objective: To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α) antagonists. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Sarilumab, Golimumab and methotrexate (MTX)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 14 sitesin 6 countries
- Study dates
- Nov 2010to Sep 2011
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of rheumatoid arthritis ≥6 months duration and American College of Rheumatology (ACR) Class I-III functional status at screening and baseline visits;
- Active disease defined as:
- At least 6 of 68 tender joints and 6 of 66 swollen joints at screening and baseline visits, and
- hs-C-Reactive Protein (hs-CRP) >10 g/L or Erythrocyte Sedimentation Rate (ESR) >28 mm/hr at screening visit;
- Continuous treatment with Methotrexate for at least 12 weeks and on stable dose (minimum 10 mg/week) for at least 6 weeks prior to the screening visit;
- Participant considered as Primary TNF-α blocker nonresponder. i.e.:
- Appropriate for previous TNF-α blocker therapy
- Lack of adequate clinical response after at least 3 months TNF-α blocker therapy with MTX or other synthetic disease modifying anti-rheumatic drug (DMARD) co-therapy.
Who cannot join
- Age <18 years or >75 years;
- Pregnant or breastfeeding woman or woman of childbearing potential, unwilling to utilize adequate contraception or not to become pregnant during the entire study;
- Fever (>38°C), or chronic, persistent, or recurring infection(s);
- History of demyelinating disease;
- Current underlying hepatobiliary disease.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
United States4 sites
Investigational Site Number 840038
Austin, Texas, 78705
Investigational Site Number 840026
Freehold, New Jersey, 07728
Investigational Site Number 840025
Jackson, Tennessee, 38305
Investigational Site Number 840043
New York, New York, 11201
Colombia3 sites
Investigational Site Number 170004
Barranquilla
Investigational Site Number 170005
Barranquilla
Investigational Site Number 170007
Bucaramanga
Italy2 sites
Investigational Site Number 380002
Florence, 50141
Investigational Site Number 380005
Genova, 16132
Mexico2 sites
Investigational Site Number 484008
Durango, 34270
Investigational Site Number 484002
Guadalajara, 44690
Spain2 sites
Investigational Site Number 724004
Oviedo, 33006
Investigational Site Number 724002
Valencia, 46009
About this study
Official title: A Randomized, Double-blind, Parallel-group, Placebo- and Active Calibrator-controlled Study Assessing the Clinical Benefit of SAR153191 Subcutaneous (SC) on Top of MTX in Patients With Active RA Who Have Failed Previous TNF-α Antagonists
Primary Objective:
- To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α) antagonists.
Secondary Objectives:
- To assess the safety of sarilumab;
- To document the pharmacokinetic profile of sarilumab.
Read the detailed description
The duration of the study period for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-week double-blind treatment period and 6-week safety follow-up period.
Participants who completed the 12-week treatment period were offered enrollment in a separate long-term extension study (LTS11210/NCT01146652).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Sarilumab, Placebo, Golimumab, methotrexate (MTX), Folic/folinic acid
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SarilumabDrug
Also called SAR153191, REGN88
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
PlaceboDrug
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
GolimumabDrug
Also called Simponi®
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
methotrexate (MTX)Drug
Pharmaceutical form: tablet or solution for injection
Route of administration: Oral (tablet) or subcutaneous, intramuscular (solution)
Folic/folinic acidDrug
Pharmaceutical form: tablet
Route of administration: oral Folic/folinic acid continued according to local standard.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo 2 mL to match sarilumab once a week (qw) and 0.5 mL to match golimumab every 4 weeks (q4w) on top of MTX (15-25 mg) qw for 12 weeks. Receives: Drug: Placebo; Drug: methotrexate (MTX); Drug: Folic/folinic acid |
| Golimumab 50 mg | Active comparator | Golimumab 50 mg q4w and placebo (matched to sarilumab) qw on top of MTX (15-25 mg) qw for 12 weeks. Receives: Drug: Placebo; Drug: Golimumab; Drug: methotrexate (MTX); Drug: Folic/folinic acid |
| Sarilumab 150 mg | Experimental | Sarilumab 150 mg qw and placebo (matched to golimumab) q4w on top of MTX (15-25 mg) qw for 12 weeks. Receives: Drug: Sarilumab; Drug: Placebo; Drug: methotrexate (MTX); Drug: Folic/folinic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved at Least 20% Improvement in American College of Rheumatology (ACR20) Core Set Disease Activity Index at Week 12
Measured: Week 12
Secondary outcomes (6)
Percentage of Participants Who Achieved at Least 50% Improvement in American College of Rheumatology (ACR50) Core Set Disease Activity Index at Week 12
Measured: Week 12
Percentage of Participants Who Achieved at Least 70% Improvement in American College of Rheumatology Core (ACR70) Set Disease Activity Index at Week 12
Measured: Week 12
Disease Activity Score for 28 Joints (DAS28) at Week 12
Measured: Week 12
European League Against Rheumatism (EULAR) Response at Week 12
Measured: Week 12
Percentage of Participants Achieving DAS28 Remission Score < 2.6 at Week 12
Measured: Week 12
Pharmacokinetic (PK) Parameter: Serum Concentration of Functional and Bound Sarilumab
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Due to delay in the study and the impact on the development timelines, not due to any identified safety concerns
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.
- Other trials for Rheumatoid ArthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217814
- Sponsor's protocol ID
- ACT11575
- Other IDs
- 2010-021020-94, U1111-1115-3763
- Status last verified
- Jul 2017
- First submitted
- 7 Oct 2010
- Last updated
- 1 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Placebo- and Active Calibrator-controlled Study Assessing the Clinical Benefit of SAR153191 Subcutaneous (SC) on Top of MTX in Patients With Active RA Who Have Failed Previous TNF-α Antagonists
- ClinicalTrials.gov ID
- NCT01217814
- Acronym / sponsor ID
- ACT11575
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to delay in the study and the impact on the development timelines, not due to any identified safety concerns
- Enrolment
- 16 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Posted 1 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α) antagonists.
Secondary Objectives:
- To assess the safety of sarilumab;
- To document the pharmacokinetic profile of sarilumab.
Detailed description
The duration of the study period for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-week double-blind treatment period and 6-week safety follow-up period.
Participants who completed the 12-week treatment period were offered enrollment in a separate long-term extension study (LTS11210/NCT01146652).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Drug: methotrexate (MTX), Drug: Folic/folinic acidPlacebo 2 mL to match sarilumab once a week (qw) and 0.5 mL to match golimumab every 4 weeks (q4w) on top of MTX (15-25 mg) qw for 12 weeks. |
| Golimumab 50 mg | Active comparator | Drug: Placebo, Drug: Golimumab, Drug: methotrexate (MTX), Drug: Folic/folinic acidGolimumab 50 mg q4w and placebo (matched to sarilumab) qw on top of MTX (15-25 mg) qw for 12 weeks. |
| Sarilumab 150 mg | Experimental | Drug: Sarilumab, Drug: Placebo, Drug: methotrexate (MTX), Drug: Folic/folinic acidSarilumab 150 mg qw and placebo (matched to golimumab) q4w on top of MTX (15-25 mg) qw for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of rheumatoid arthritis ≥6 months duration and American College of Rheumatology (ACR) Class I-III functional status at screening and baseline visits;
- Active disease defined as:
- Continuous treatment with Methotrexate for at least 12 weeks and on stable dose (minimum 10 mg/week) for at least 6 weeks prior to the screening visit;
- Participant considered as Primary TNF-α blocker nonresponder. i.e.:
Key exclusion criteria (6 listed)
- Age <18 years or >75 years;
- Pregnant or breastfeeding woman or woman of childbearing potential, unwilling to utilize adequate contraception or not to become pregnant during the entire study;
- Fever (>38°C), or chronic, persistent, or recurring infection(s);
- History of demyelinating disease;
- Current underlying hepatobiliary disease.
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 |
|---|---|---|
| SarilumabAlso: SAR153191, REGN88Pharmaceutical form: solution for injection Route of administration: subcutaneous | Drug | Sarilumab 150 mg |
| PlaceboPharmaceutical form: solution for injection Route of administration: subcutaneous | Drug | Golimumab 50 mg, Placebo, Sarilumab 150 mg |
| GolimumabAlso: Simponi®Pharmaceutical form: solution for injection Route of administration: subcutaneous | Drug | Golimumab 50 mg |
| methotrexate (MTX)Pharmaceutical form: tablet or solution for injection Route of administration: Oral (tablet) or subcutaneous, intramuscular (solution) | Drug | Golimumab 50 mg, Placebo, Sarilumab 150 mg |
| Folic/folinic acidPharmaceutical form: tablet Route of administration: oral Folic/folinic acid continued according to local standard. | Drug | Golimumab 50 mg, Placebo, Sarilumab 150 mg |
Primary outcome
Percentage of Participants Who Achieved at Least 20% Improvement in American College of Rheumatology (ACR20) Core Set Disease Activity Index at Week 12
Time frame: Week 12
6 secondary outcomes
Percentage of Participants Who Achieved at Least 50% Improvement in American College of Rheumatology (ACR50) Core Set Disease Activity Index at Week 12
Time frame: Week 12
Percentage of Participants Who Achieved at Least 70% Improvement in American College of Rheumatology Core (ACR70) Set Disease Activity Index at Week 12
Time frame: Week 12
Disease Activity Score for 28 Joints (DAS28) at Week 12
Time frame: Week 12
European League Against Rheumatism (EULAR) Response at Week 12
Time frame: Week 12
Percentage of Participants Achieving DAS28 Remission Score < 2.6 at Week 12
Time frame: Week 12
Pharmacokinetic (PK) Parameter: Serum Concentration of Functional and Bound Sarilumab
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sarilumab, Golimumab and methotrexate (MTX) in people with Rheumatoid Arthritis, run by Sanofi at 14 sites in 6 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 8 inclusion and 6 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 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Colombia, Italy, Mexico, Spain and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 Sep 2017). 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?
Percentage of Participants Who Achieved at Least 20% Improvement in American College of Rheumatology (ACR20) Core Set Disease Activity Index at Week 12 (time frame: Week 12). 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 1 Sep 2017.