A Phase 3 interventional study of sarilumab SAR153191 (REGN88) in Rheumatoid Arthritis, sponsored by Sanofi. Completed at 28 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-20.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Primary Objective:
To evaluate the immunogenicity of sarilumab administered as monotherapy.
Secondary Objectives:
Total study duration was up to 34 weeks: Up to 4-week screening period, 24-week open-label treatment phase, 6-week post-treatment observation. After completion of the treatment phase of this study, participants were eligible to enter a long term safety study (LTS11210 - SARIL-RA-EXTEND) for continuous treatment with sarilumab (SAR153191 [REGN88]).
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 132 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a Participant's potential participation in a clinical trial.
Sarilumab 150 mg subcutaneous (SC) injection every two weeks (q2w) for 24 weeks.
Drug: sarilumab SAR153191 (REGN88)
Sarilumab 200 mg SC injection q2w for 24 weeks.
Drug: sarilumab SAR153191 (REGN88)
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product \[IMP\] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30.
Time frame: From Baseline to Week 30 [End of study (EOS)]
Serum Sarilumab Concentration
Trough Concentration (Ctrough).
Time frame: Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30
The study was conducted at 27 centers in 7 countries. A total of 201 participants were screened between 03 June 2014 and 20 October 2014.
| Milestone | Sarilumab 150 mg q2w | Sarilumab 200 mg q2w |
|---|---|---|
| Started | 65 | 67 |
| Completed | 58 | 58 |
| Not completed | 7 | 9 |
| Withdrew: Adverse event | 5 | 7 |
| Withdrew: Lack of efficacy | 2 | 0 |
| Withdrew: Other than specified above | 0 | 2 |
ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product \[IMP\] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30.
| Percentage of participants | Sarilumab 150 mg q2w | Sarilumab 200 mg q2w |
|---|---|---|
| Overall positive | 24.6 | 18.2 |
| Persistent positive | 12.3 | 6.1 |
| Persistent neutralizing positive | 10.8 | 3.0 |
Trough Concentration (Ctrough).
| ng/mL | Sarilumab 150 mg q2w | Sarilumab 200 mg q2w |
|---|---|---|
| Serum Sarilumab Concentration | 7350 ± 8030 | 17200 ± 15900 |
Collected over All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sarilumab 150mg q2w | — | 1/65 (1.5%) | 16/65 (24.6%) |
| Sarilumab 200mg q2w | — | 2/67 (3%) | 23/67 (34.3%) |
| Event | Sarilumab 150mg q2w | Sarilumab 200mg q2w |
|---|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 1/65 | 0/67 |
| NeutropeniaBlood and lymphatic system disorders | 0/65 | 1/67 |
| LacerationInjury, poisoning and procedural complications | 0/65 | 1/67 |
| Event | Sarilumab 150mg q2w | Sarilumab 200mg q2w |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 8/65 | 11/67 |
| Injection site erythemaGeneral disorders | 5/65 | 2/67 |
| Upper respiratory tract infectionInfections and infestations | 3/65 | 4/67 |
| Urinary tract infectionInfections and infestations | 2/65 | 4/67 |
| HypertensionVascular disorders | 0/65 | 4/67 |
Randomized population that included any participant who signed an informed consent and was allocated to a randomized treatment regardless of whether the treatment kit was used or not.
| Age, Continuous(years) | Sarilumab 150 mg q2w | Sarilumab 200 mg q2w | Total |
|---|---|---|---|
| Mean | 51.1 ± 12.7 | 53.6 ± 14.1 | 52.4 ± 13.4 |
| Sex: Female, Male(Participants) | Sarilumab 150 mg q2w | Sarilumab 200 mg q2w | Total |
|---|---|---|---|
| Female | 49 | 57 | 106 |
| Male | 16 | 10 | 26 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi