Phase 2 Rheumatoid Arthritis Trial, Recruiting NCT07704580 Sponsor: Sanofi Condition: Rheumatoid Arthritis
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Phase 2 Rheumatoid Arthritis Trial, Recruiting

NCT07704580
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are 18 years old or older (or the legal age of consent in the country where the study is taking place) at the time of signing the consent form.
  • People who have been diagnosed with rheumatoid arthritis (RA) according to recognised international classification standards, with the condition present for at least 3 months.
  • People whose RA falls within a certain range of physical function, classified as ACR Class I to III based on 1991 criteria (confirm with trial site).
  • People with moderate-to-severely active RA, measured using a specific disease activity score called DAS28-ESR above 3.2 (confirm with trial site).
  • People who have had to stop a standard first-line RA medication because it did not work well enough or caused intolerable side effects.
  • People who are using contraception in line with local regulations for clinical study participants.

Who may not be able to join:

  • People who have recently used certain immune-suppressing medications, including JAK inhibitors (such as tofacitinib) within 4 weeks, B-cell depleting agents (such as anti-CD20 therapies) without evidence of B-cell recovery, anakinra within 1 week, abatacept within 8 weeks, TNF inhibitors within 2 to 8 weeks, cyclophosphamide within 6 months, or cyclosporine, azathioprine, mycophenolate mofetil, or leflunomide within 4 weeks of the study start date.
  • People whose previous treatment with a biological IL-6 blocking medication failed due to it not working, causing intolerable side effects, or being medically unsuitable for them (though stopping an IL-6 treatment for unrelated reasons at least 3 months before the study start may not be disqualifying — confirm with trial site).
  • People who are on methotrexate at a dose that has not been stable.
  • People currently taking systemic corticosteroids (steroid tablets or injections) at a dose of more than 10 mg per day.
  • People who are pregnant or breastfeeding.
  • People who have active tuberculosis (TB) or a history of TB that was not fully treated.
  • People who have had a serious infection caused by certain fungi, bacteria, or viruses, including conditions such as histoplasmosis, candidiasis, aspergillosis, or a brain condition called progressive multifocal leukoencephalopathy, even if it has resolved.
  • People with diabetes that is not well controlled.
  • People who have had an infection in a joint or an artificial joint in the past.
  • People with a current or past history of cancer (within the past 5 years), including blood cancers, except for certain treated skin cancers or treated cervical pre-cancer.
  • People with a history of inflammatory bowel disease, severe diverticulitis, or a previous tear or rupture in the digestive tract.
  • People who have a history of juvenile idiopathic arthritis or whose arthritis began before the age of 16.
  • People with severe, body-wide forms of RA, including conditions such as vasculitis, pulmonary fibrosis, or Felty's syndrome.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 800-633-1610

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
2 July 2026
Est. completion
26 October 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Part A: Assessment of Pharmacokinetic (PK) parameters of sarilumab in serum: area under the concentration-time curve [AUClast] for IV doses; Part A: Assessment of PK parameters of sarilumab in serum: maximum concentration [Cmax] for IV doses; Part B: Assessment of PK parameters of sarilumab in serum: plasma concentration at steady state (Ctrough ss)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov