Rheumatoid Arthritis study: Sarilumab
Official title Phase 1b/2 Study of IV Sarilumab in Adult With RA
ClinicalTrials.gov ID: NCT07704580
What this study is testing
What is Sarilumab (Kevzara®)?
an investigational subcutaneous injectable medicine being studied for rheumatoid arthritis is designed to block the interleukin‑6 (IL‑6) receptor, reducing inflammation
Also referred to as Kevzara.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to check the safety of the drug and see how the body handles it when given as an IV infusion.
- Who it's for
- Adults aged 18 or older with moderately to severely active rheumatoid arthritis.
- What's involved
- Participants will receive IV sarilumab, possibly with other oral arthritis medications, and undergo regular medical tests and visits.
- Time commitment
- The study lasts up to 64 weeks and requires up to 17 clinic visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Diagnosis of RA, according to the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) 2010 RA...
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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...
- 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...
- 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...
- 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 study team makes the final eligibility decision.
Where it is enrolling
- Centennial, Colorado, United States
- Clearwater, Florida, United States
- Hialeah, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Weston, Florida, United States
- Duncansville, Pennsylvania, United States
- El Paso, Texas, United States
- Houston, Texas, United States
- Mesquite, Texas, United States
- Plano, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Centennial, Colorado, United States; Clearwater, Florida, United States; Hialeah, Florida, United States; Hollywood, Florida, United States; Miami, Florida, United States; Plantation, Florida, United States and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.