Rheumatoid Arthritis Trial, Recruiting NCT07045896 Sponsor: Peking University People's Hospital Condition: Rheumatoid Arthritis
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Rheumatoid Arthritis Trial, Recruiting

NCT07045896
Recruiting Not Applicable

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:

  • Adults between 18 and 65 years old (inclusive) at the screening stage, of any gender, who weigh at least 35 kg.
  • People who have been diagnosed with rheumatoid arthritis according to recognised 2010 classification standards.
  • People whose rheumatoid arthritis is currently active and showing moderate-to-high levels of disease activity, despite receiving treatment.
  • People taking standard anti-inflammatory or pain medications, provided the dose has been stable for at least 2 weeks before the first study dose and stays unchanged throughout the trial.
  • People taking oral steroid medications, provided they have been on them for at least 4 weeks, at a stable and relatively low dose, for at least 4 weeks before the first study dose, and the dose stays unchanged throughout the trial.
  • People taking certain disease-modifying medications (specifically methotrexate or leflunomide, within defined dose limits), provided they have been on them for at least 8 weeks, with the dose stable for at least 4 weeks before the first study dose, and unchanged throughout the trial.
  • Women who could potentially become pregnant must have a negative pregnancy test at the screening stage.
  • Women who could potentially become pregnant, and men who have not had a vasectomy, must use effective contraception from signing consent until 3 months after the last dose.
  • People who are willing and able to follow the trial's requirements and schedule.
  • People who are willing to give written informed consent and understand what the trial involves.

Who may not be able to join:

  • People currently receiving biologic therapy (a specific type of medication used for immune conditions).
  • People who have other inflammatory joint diseases or connective tissue diseases beyond rheumatoid arthritis.
  • People with significant bone marrow problems, or seriously low levels of red blood cells, white blood cells, or platelets, where this is not caused by active rheumatoid arthritis.
  • People who have had a persistent or serious infection within the 3 months before enrolling.
  • People with uncontrolled high blood pressure, uncontrolled diabetes, unstable heart disease, active inflammatory bowel disease, active stomach ulcers, a terminal illness, or any other condition the trial doctor considers too risky for participation.
  • People with serious heart, liver, neurological, hormonal, or other major health conditions that could interfere with the trial or its results.
  • People with severely low protein levels in the blood (for example, due to serious liver disease or a kidney condition called nephrotic syndrome).
  • People with moderate or severe kidney impairment, based on a specific blood test result (confirm with trial site).
  • People with a recent or significant history of drug or alcohol misuse.
  • People with impaired liver function, or persistently elevated liver enzyme levels above a certain threshold.
  • People who are pregnant.
  • People who are breastfeeding.
  • People with a serious immune deficiency (either from birth or acquired), a history of cancer or lymphoma-related disorders, or those who have previously undergone total lymphoid irradiation (a type of radiation treatment).
  • People who are known to be HIV-positive.
  • People with known positive test results for hepatitis B or hepatitis C.
  • People already enrolled in another clinical trial involving an investigational drug or device, or any other medical research study.
  • People who have needed antibiotic or antimicrobial treatment for any active infection in the 28 days before the first study dose.
  • People whose body mass index (BMI) is below 18.5 or above 30 (confirm with trial site).

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 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Fanlei Hu, Peking University People's Hospital

Phone: 0086-18811797572

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
Not Applicable
Sponsor
Peking University People's Hospital
Registry
ClinicalTrials.gov
Start date
10 January 2026
Est. completion
1 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The proportion of patients achieving the American College of Rheumatology 20% improvement criteria (ACR20) at Week 12.

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: 27 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