No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
140 (estimated)
Sponsor
Sanofi · Industry
Who this trial is looking for
This trial is looking for adults with rheumatoid arthritis who have not responded well to previous treatments. Participants will receive treatments and be followed for up to 64 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with rheumatoid arthritis for at least 3 months.
I have moderate to severe active rheumatoid arthritis.
I cannot continue my current rheumatoid arthritis treatment due to intolerance or inadequate response.
I have a functional status of ACR Class I to III.
I agree to use contraception as required.
You may not be able to join if
I have used certain immunosuppressive drugs in the past few weeks.
I have been pregnant or breastfeeding.
I have active tuberculosis or an incomplete history of tuberculosis treatment.
I have had serious infections in the past.
I have uncontrolled diabetes.
I have a history of cancer in the past 5 years.
I have a severe systemic form of rheumatoid arthritis.
I have a history of certain bowel diseases.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is a Phase 1/Phase 2 study with:
* 5-arms design for Part A;
* and a single arm for Part B.
The purpose of this study is to measure PK parameters and safety with sarilumab intravenous (IV) with or without concomitant oral conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) in male and female participants with moderately to severely active rheumatoid arthritis aged 18 yea…
This is a Phase 1/Phase 2 study with:
* 5-arms design for Part A;
* and a single arm for Part B.
The purpose of this study is to measure PK parameters and safety with sarilumab intravenous (IV) with or without concomitant oral conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) in male and female participants with moderately to severely active rheumatoid arthritis aged 18 years of age or older.
Study details include:
* The study duration will be up to 64 weeks.
* The treatment duration will be up to 6 months for each study phase.
* Part A has 10 visits, including a post-treatment end of study (EOS) follow-up visit.
* For participants entering the open label extension to receive the approved 200 mg sarilumab every two weeks (Q2W) dose, there will be 3 additional study visits.
* For the intra-study sarilumab 200 mg Q2W subcutaneous (SC) arm, participants will be evaluated over the course of 24 weeks plus post-treatment EOS follow-up visit following the schedule of activities (SoA) of Part A from Day -1 to Day 29 (total of 8 visits) and the SoA of Part B from Week 4 to Week 24 (total of 8 visits) and a post-treatment end of study (EOS) follow-up visit at Week 30 (Part B) for a total of 17 visits, including a post-treatment EOS follow-up visit.
* Part B has 13 visits, including a post-treatment EOS follow-up visit.
Trial Locations
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Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Participant must be 18 years old or the legal age of consent in the jurisdiction in which the study is taking place or older, at the time of signing the informed consent.
* Diagnosis of RA, according to the American College of Rheumatology (ACR)/European Alliance of Associatio…
Inclusion Criteria:
* Participant must be 18 years old or the legal age of consent in the jurisdiction in which the study is taking place or older, at the time of signing the informed consent.
* Diagnosis of RA, according to the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) 2010 RA Classification Criteria with ≥3 months disease duration.
* ACR Class I to III functional status, based on the 1991 revised criteria
* Moderate-to-severely active RA, defined as: DAS28-ESR\>3.2.
* Inability to continue treatment with a RA DMARD approved for first line use because of intolerance or inadequate response.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
* Any prior (within the defined periods below) or concurrent use of immunosuppressive:
* Janus kinase (JAK) inhibitor (eg, tofacitinib) within 4 weeks of baseline.
* Cell-depletion agents (eg, anti CD20) without evidence of recovery of B cells to baseline level.
* Anakinra within 1 week of baseline.
* Abatacept within 8 weeks of baseline.
* Tumor necrosis factor (TNF) inhibitors within 2 to 8 weeks.
* Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline.
* Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide within 4 weeks of baseline.
* Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological IL-6 antagonist (prior IL-6 antagonist treatment that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline is not exclusionary).
* Unstable methotrexate (MTX) dose (if participant is on concomitant MTX).
* Concurrent use of systemic corticosteroids (CS) of more than 10 mg/day.
* Pregnant or breastfeeding woman.
* Exclusion related to tuberculosis (TB): active TB or a history of incompletely treated TB regardless of screening Quantiferon® result.
* History of invasive opportunistic infections, including but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, aspergillosis despite resolution or John Cunningham virus (progressive multifocal leukoencephalopathy).
* Uncontrolled diabetes mellitus.
* History of prior articular or prosthetic joint infection.
* Prior or current history of malignancy, including lymphoproliferative diseases, 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 baseline visit.
* History of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.
* History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
* Severe systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Contacts
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