Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01146652 | Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND) | PHASE3 | COMPLETED | 2,023 | — | — | Jun 21, 2010 | Dec 31, 2020 | Mar 28, 2022 | 335 | United States, Argentina +38 |
| NCT01328522 | Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients | PHASE1 | COMPLETED | 32 | — | — | May 1, 2011 | Sep 1, 2011 | Oct 24, 2011 | 4 | United States |
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product and which did not necessarily have to have a causal relationship with the treatment. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product (IMP) in study LTS11210 to the last dose of the IMP +60 days).
A PTF was defined as any product technical complaint (PTC) related to the use of the PFS-S that had a validated technical cause. FDD was defined as participant's failure to administer the full dose at a given attempt. A PTC was defined as any participant- or healthcare provider-reported complaint regarding the use of the PFS-S syringe and collected via the completion of the injection diary. The injection diary comprised specific questions: 1. Were you able to remove the cap? 2. Was the needle safety system activated?, 3. Did the safety system entirely cover the needle, and 4. Was the person who performed the injection the person who was trained by the site staff?, where each question was given the option yes/no. Participants who answered "no" for any of the questions of PTC, had PTF and/or FDD were reported in this outcome measure.
A PTF was defined as any PTC (defined as any participant- or healthcare provider-reported complaint regarding the use of the PFS-S syringe and collected via the completion of the injection diary) related to the use of the PFS-S that had a validated technical cause. Number of PTF in the participants enrolled in sub-study were reported in this outcome measure.
FDD was defined as participant's failure to administer the full dose at a given attempt. Number of FDD in the participants enrolled in sub-study were reported in this outcome measure.
A PTC was defined as any participant- or healthcare provider-reported complaint regarding the use of the PFS-S syringe and collected via the completion of the injection diary. The injection diary comprised specific questions: 1. Were you able to remove the cap? 2. Was the needle safety system activated?, 3. Did the safety system entirely cover the needle, and 4. Was the person who performed the injection the person who was trained by the site staff?, where each question was given the option yes/no. Number of PTC (based on participant's answer to "no" for any of the questions of PTC) in the participants enrolled in sub-study were reported in this outcome measure.
| Arm | Type | Description |
|---|---|---|
| Sarilumab + Disease Modifying Anti-Rheumatic Drugs (DMARD) | EXPERIMENTAL | Participants who completed any of initial studies:Part A or B of EFC11072, ACT11575, EFC10832 or SFY13370 were enrolled in LTS11210 and received sarilumab 150 milligrams (mg) subcutaneously (SC) once weekly (qw). Dose could be reduced to 150 mg every 2 weeks (q2w) due to neutropenia, thrombocytopenia or increase in liver enzymes (alanine aminotransferase \[ALT\]). After dose regimens selection for Phase 3 studies (150 mg q2w and 200 mg q2w), participants already receiving 150 mg qw were switched to sarilumab 200 mg q2w. Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks). Participants who were already taking concomitant non-biologic DMARDs in initial study continued stable dose of one or combination of conventional synthetic DMARDs they were taking. |
| Sarilumab monotherapy | EXPERIMENTAL | Participants who completed study EFC13752 were enrolled in LTS11210 and received sarilumab 200 mg q2w. Dose could be reduced to 150 mg q2w due to neutropenia, thrombocytopenia or increase in liver enzymes (ALT). Treatment duration per participant was at least 264 weeks from first study drug administration in LTS11210. Participants continued to be treated beyond 264 weeks until sarilumab was commercially available in their respective countries or until 2020, at the latest (maximum duration: 523 weeks). |
| SAR153191 drug product 1 | EXPERIMENTAL | SAR153191 drug product 1 in a single injection. Methotrexate (stable dose) and folic/folinic acid are continued as background therapy. |
| SAR153191 drug product 2 | EXPERIMENTAL | SAR153191 drug product 2 in a single injection. Methotrexate (stable dose) and folic/folinic acid are continued as background therapy. |
| Name | Type | Description |
|---|---|---|
| SAR153191 (REGN88) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
Inclusion criteria : Main study: Participants with RA who were previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, SFY13370, and EFC13752 study. Sub-study: Participants enrolled in the LTS11210 study who were receiving either sari...