Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers
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ClinicalTrials.gov Identifier: NCT01217814 |
Recruitment Status
:
Terminated
(Due to delay in the study and the impact on the development timelines, not due to any identified safety concerns)
First Posted
: October 8, 2010
Results First Posted
: September 1, 2017
Last Update Posted
: September 1, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: Sarilumab Drug: Placebo Drug: Golimumab Drug: methotrexate (MTX) Drug: Folic/folinic acid | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2011 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
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.
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Drug: Placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous Pharmaceutical form: tablet or solution for injection Route of administration: Oral (tablet) or subcutaneous, intramuscular (solution) Pharmaceutical form: tablet Route of administration: oral Folic/folinic acid continued according to local standard. |
Active Comparator: Golimumab 50 mg
Golimumab 50 mg q4w and placebo (matched to sarilumab) qw on top of MTX (15-25 mg) qw for 12 weeks.
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Drug: Placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous Pharmaceutical form: solution for injection Route of administration: subcutaneous Other Name: Simponi®
Drug: methotrexate (MTX)
Pharmaceutical form: tablet or solution for injection Route of administration: Oral (tablet) or subcutaneous, intramuscular (solution) Pharmaceutical form: tablet Route of administration: oral Folic/folinic acid continued according to local standard. |
Experimental: Sarilumab 150 mg
Sarilumab 150 mg qw and placebo (matched to golimumab) q4w on top of MTX (15-25 mg) qw for 12 weeks.
|
Drug: Sarilumab
Pharmaceutical form: solution for injection Route of administration: subcutaneous Other Names:
Drug: Placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous Pharmaceutical form: tablet or solution for injection Route of administration: Oral (tablet) or subcutaneous, intramuscular (solution) Pharmaceutical form: tablet Route of administration: oral Folic/folinic acid continued according to local standard. |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Diagnosis of rheumatoid arthritis ≥6 months duration and American College of Rheumatology (ACR) Class I-III functional status at screening and baseline visits;
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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;
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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.
Exclusion criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217814
United States, New Jersey | |
Investigational Site Number 840026 | |
Freehold, New Jersey, United States, 07728 | |
United States, New York | |
Investigational Site Number 840043 | |
New York, New York, United States, 11201 | |
United States, Tennessee | |
Investigational Site Number 840025 | |
Jackson, Tennessee, United States, 38305 | |
United States, Texas | |
Investigational Site Number 840038 | |
Austin, Texas, United States, 78705 | |
Colombia | |
Investigational Site Number 170004 | |
Barranquilla, Colombia | |
Investigational Site Number 170005 | |
Barranquilla, Colombia | |
Investigational Site Number 170007 | |
Bucaramanga, Colombia | |
Czechia | |
Investigational Site Number 203002 | |
Uherske Hradiste, Czechia, 68601 | |
Italy | |
Investigational Site Number 380002 | |
Firenze, Italy, 50141 | |
Investigational Site Number 380005 | |
Genova, Italy, 16132 | |
Mexico | |
Investigational Site Number 484008 | |
Durango, Mexico, 34270 | |
Investigational Site Number 484002 | |
Guadalajara, Mexico, 44690 | |
Spain | |
Investigational Site Number 724004 | |
Oviedo, Spain, 33006 | |
Investigational Site Number 724002 | |
Valencia, Spain, 46009 |
Study Director: | Clinical Sciences & Operations | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01217814 History of Changes |
Other Study ID Numbers: |
ACT11575 2010-021020-94 ( EudraCT Number ) U1111-1115-3763 ( Other Identifier: UTN ) |
First Posted: | October 8, 2010 Key Record Dates |
Results First Posted: | September 1, 2017 |
Last Update Posted: | September 1, 2017 |
Last Verified: | July 2017 |
Additional relevant MeSH terms:
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Antibodies, Monoclonal Leucovorin Levoleucovorin Folic Acid Abortifacient Agents, Nonsteroidal Abortifacient Agents |
Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Antidotes Protective Agents |