Rheumatoid ArthritisPhase 3SARIL-RA-ONENCT02121210
To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)
A Phase 3 study testing sarilumab SAR153191 (REGN88) in people with Rheumatoid Arthritis, run by Sanofi at 28 sites in 7 countries.
Trial summary
Primary Objective: To evaluate the immunogenicity of sarilumab administered as monotherapy. Secondary Objectives: To evaluate the other safety aspects of sarilumab administered as monotherapy. To assess the exposure of sarilumab administered as monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- sarilumab SAR153191 (REGN88)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 28 sitesin 7 countries
- Study dates
- Jun 2014to 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
- Diagnosis of rheumatoid arthritis (RA) ≥ 3 months.
- Moderately to severely active rheumatoid arthritis.
- Participants who per investigator judgment were incomplete responders to at least 12 weeks of an adequate dose of continuous treatment with or who were intolerant of one or a combination of non-biologic disease modifying anti-rheumatic drugs (DMARDs).
Who cannot join
- Participants < 18 years of age.
- Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA.
- History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
- Severe active systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome.
- Prior treatment with any biologic anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies.
- Treatment with prednisone > 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.
Show all 15Show fewer
- New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors within 4 weeks prior to randomization, except for the use of low-dose acetylsalicylic acid for cardiovascular diseases.
- Use of parenteral glucocorticoids or intra-articular glucocorticoids injection within 4 weeks prior to randomization.
- Prior treatment with a Janus kinase (JAK) inhibitor (tofacitinib).
- New treatment or dose-adjustment to on-going medication for dyslipidemia, such as statin, within 6 weeks prior to randomization.
- Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first dose of study drug administration, whichever is longer.
- Participants with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization visit. Non-malignant lymphoproliferative disorders are also excluded.
- Participants with active tuberculosis or untreated latent tuberculosis infection.
- Pregnant or breast feeding women.
- 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
28 sites in 7 countries.
28 sites in 7 countries
United States13 sites
Investigational Site Number 840032
Amarillo, Texas, 79124
Investigational Site Number 840124
Clarksburg, West Virginia, 26301
Investigational Site Number 840009
Duncansville, Pennsylvania, 16635
Investigational Site Number 840230
Elizabethtown, Kentucky, 42701
Investigational Site Number 840231
Franklin, Wisconsin, 53132
Investigational Site Number 840072
Gilbert, Arizona, 85234
Investigational Site Number 840025
Jackson, Tennessee, 38305
Investigational Site Number 840074
Mesquite, Texas, 75150
Investigational Site Number 840233
Minot, North Dakota, 58701
Investigational Site Number 840127
Oklahoma City, Oklahoma, 73103
Investigational Site Number 840220
South Miami, Florida, 33143
Investigational Site Number 840011
Tulsa, Oklahoma, 74104
Investigational Site Number 840049
Upland, California, 91786
Czechia3 sites
Investigational Site Number 203034
Pardubice, 53002
Investigational Site Number 203001
Prague, 12850
Investigational Site Number 203002
Uherské Hradiště, 686 01
Hungary3 sites
Investigational Site Number 348014
Budapest, 1027
Investigational Site Number 348025
Budapest, 1027
Investigational Site Number 348021
Esztergom, 2500
Poland3 sites
Investigational Site Number 616018
Poznan, 61-397
Investigational Site Number 616031
Warsaw, 01-518
Investigational Site Number 616012
Wroclaw, 50-044
Russia3 sites
Investigational Site Number 643006
Kemerovo, 650000
Investigational Site Number 643001
Moscow, 115522
Investigational Site Number 643016
Ryazan, 390026
Estonia2 sites
Investigational Site Number 233010
Tallinn, 10138
Investigational Site Number 233002
Tallinn, 13419
About this study
Official title: An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis
Primary Objective:
To evaluate the immunogenicity of sarilumab administered as monotherapy.
Secondary Objectives:
- To evaluate the other safety aspects of sarilumab administered as monotherapy.
- To assess the exposure of sarilumab administered as monotherapy.
Read the detailed description
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]).
- Conditions
- Rheumatoid Arthritis
- Being tested
- sarilumab SAR153191 (REGN88)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sarilumab SAR153191 (REGN88)Drug
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Sarilumab 150 mg q2w | Experimental | Sarilumab 150 mg subcutaneous (SC) injection every two weeks (q2w) for 24 weeks. Receives: Drug: sarilumab SAR153191 (REGN88) |
| Sarilumab 200 mg q2w | Experimental | Sarilumab 200 mg SC injection q2w for 24 weeks. Receives: Drug: sarilumab SAR153191 (REGN88) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to Week 30 [End of study (EOS)]
Secondary outcomes (1)
Serum Sarilumab Concentration
Trough Concentration (Ctrough).
Measured: Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- 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 (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 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
- NCT02121210
- Sponsor's protocol ID
- EFC13752
- Other IDs
- 2013-002790-22, U1111-1143-4344
- Acronym
- SARIL-RA-ONE
- Status last verified
- May 2017
- First submitted
- 21 Apr 2014
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wells AF, Parrino J, Mangan EK, Paccaly A, Lin Y, Xu C, Fan C, Graham NMH, van Hoogstraten H, Torri A. Immunogenicity of Sarilumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Inadequate Responders or Intolerant to Disease-Modifying Antirheumatic Drugs. Rheumatol Ther. 2019 Sep;6(3):339-352. doi: 10.1007/s40744-019-0157-3. Epub 2019 May 14.
PubMed 31090044
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02121210
- Acronym / sponsor ID
- SARIL-RA-ONE / EFC13752
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Posted 20 Jun 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 evaluate the immunogenicity of sarilumab administered as monotherapy.
Secondary Objectives:
- To evaluate the other safety aspects of sarilumab administered as monotherapy.
- To assess the exposure of sarilumab administered as monotherapy.
Detailed description
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]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarilumab 150 mg q2w | Experimental | Drug: sarilumab SAR153191 (REGN88)Sarilumab 150 mg subcutaneous (SC) injection every two weeks (q2w) for 24 weeks. |
| Sarilumab 200 mg q2w | Experimental | Drug: sarilumab SAR153191 (REGN88)Sarilumab 200 mg SC injection q2w for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of rheumatoid arthritis (RA) ≥ 3 months.
- Moderately to severely active rheumatoid arthritis.
- Participants who per investigator judgment were incomplete responders to at least 12 weeks of an adequate dose of continuous treatment with or who were intolerant of one or a combination of non-biologic disease modifying anti-rheumatic drugs (DMARDs).
Key exclusion criteria (15 listed)
- Participants < 18 years of age.
- Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA.
- History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
- Severe active systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome.
- Prior treatment with any biologic anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies.
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 |
|---|---|---|
| sarilumab SAR153191 (REGN88)Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous | Drug | Sarilumab 150 mg q2w, Sarilumab 200 mg q2w |
Primary outcome
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Time frame: From Baseline to Week 30 [End of study (EOS)]
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.
1 secondary outcome
Serum Sarilumab Concentration
Time frame: Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31090044Wells AF, Parrino J, Mangan EK, Paccaly A, Lin Y, Xu C, Fan C, Graham NMH, van Hoogstraten H, Torri A. Immunogenicity of Sarilumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Inadequate Responders or Intolerant to Disease-Modifying Antirheumatic Drugs. Rheumatol Ther. 2019 Sep;6(3):339-352. doi: 10.1007/s40744-019-0157-3. Epub 2019 May 14.
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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
28 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sarilumab SAR153191 (REGN88) in people with Rheumatoid Arthritis, run by Sanofi at 28 sites in 7 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 3 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Czechia, Hungary, Poland, Russia and 2 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 20 Jun 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 With Incidence of Antidrug Antibodies (ADA) (time frame: From Baseline to Week 30 [End of study (EOS)]). 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 NCT02121210, which also lists 1 linked publication.
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 20 Jun 2017.