Phase 4 Rheumatoid Arthritis Trial, Recruiting NCT05540938 Sponsor: China-Japan Friendship Hospital Condition: Rheumatoid Arthritis
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Phase 4 Rheumatoid Arthritis Trial, Recruiting

NCT05540938
Recruiting Phase 4

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 aged between 18 and 75 years old
  • People who have been diagnosed with rheumatoid arthritis according to recognised international diagnostic standards (1987 ACR or 2010 ACR/EULAR criteria)
  • People whose rheumatoid arthritis also meets a specific Traditional Chinese Medicine diagnosis involving kidney deficiency and blocked channels (confirm with trial site)
  • People whose rheumatoid arthritis disease activity falls within a specific low-to-moderate range, measured by a scoring system called DAS28 (a score between 2.6 and 3.2)
  • People who have been regularly taking methotrexate (7.5–15 mg once weekly) and tofacitinib (5 mg twice daily) on a stable, unchanged schedule for more than 4 weeks before joining
  • People who are willing to take part and have signed a written consent form

Who may not be able to join:

  • People who have taken immune-suppressing medications other than certain standard rheumatoid arthritis drugs (such as hydroxychloroquine, methotrexate, sulfasalazine, or leflunomide) in the 3 months before joining
  • People who have had an organ transplant, have cancer, or have significant problems with the heart, brain, liver, kidneys, blood, or other major organs
  • People who have certain mental health conditions (such as cognitive disorders, depression, or anxiety), or certain neurological conditions affecting the brain, spinal cord, or nerves (such as epilepsy, stroke, multiple sclerosis-related conditions, or restless legs syndrome)
  • People who are pregnant, breastfeeding, or planning a pregnancy within the next 6 months, as well as people of childbearing age who are unable or unwilling to use adequate contraception during the trial and for one month after the last dose (this applies to both the participant and their partner)
  • People with a Body Mass Index (BMI) over 35, people who are allergic to the study medication, or people already participating in another clinical trial
  • People the trial investigators consider unsuitable for other reasons, such as those who live too far away to attend follow-up visits

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 21 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: +8618810902100

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
China-Japan Friendship Hospital
Registry
ClinicalTrials.gov
Start date
23 May 2023
Est. completion
31 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

DAS28

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: 21 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