Could a once-every-few-weeks IV infusion tame rheumatoid arthritis?
NCT ID NCT07704580
First seen Jul 15, 2026 · Last updated Aug 12, 2026 · Updated 3 times
Summary
This study tests whether giving sarilumab (Kevzara) through an IV with longer intervals between doses is safe and works well for adults with moderate-to-severe rheumatoid arthritis. Participants receive the drug intravenously, with or without other standard arthritis medications. Researchers measure drug levels in the blood and monitor for side effects over about six months of treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental intravenous form of the drug sarilumab (also known as Kevzara)
- What this could lead to
- If successful, this could offer people with rheumatoid arthritis a more convenient dosing option with fewer injections.
- What could go wrong
- This is an early-phase study with a small number of participants, so results may not apply broadly. The longer dosing intervals might not control symptoms as effectively as the standard regimen.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2026
- Expected to finish
-
Oct 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Rheumatoid arthritis are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
4 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Altoona Center for Clinical Research - Duncansville- Site Number : 8400007
RECRUITINGDuncansville, Pennsylvania, 16635, United States
-
ClinRx Research - Plano- Site Number : 8400015
RECRUITINGPlano, Texas, 75023, United States
-
Encore Medical Research - Hollywood- Site Number : 8400010
RECRUITINGHollywood, Florida, 33024, United States
-
Encore Medical Research - Weston- Site Number : 8400011
RECRUITINGWeston, Florida, 33331, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Ocular surface changes and meibomian gland dysfunction in rheumatologic patients: a Cross-Sectional analytical study
- Hidden kidney damage may lurk in rheumatoid arthritis patients
- Can a new injection calm rheumatoid arthritis? an early trial puts ZB002 to the test
- Can a new knee implant design offer better Long-Term relief?
- Can a new biologic ease rheumatoid arthritis when standard drugs fail?
- A blood marker may reveal hidden heart risk in rheumatoid arthritis