Phase 4 Rheumatoid Arthritis Trial, Recruiting NCT04981145 Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Condition: Rheumatoid Arthritis
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Phase 4 Rheumatoid Arthritis Trial, Recruiting

NCT04981145
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 who have been diagnosed with primary Sjögren's syndrome (pSS) based on the 2016 international classification criteria for this condition.
  • People who experience symptoms of dry mouth and dry eyes.
  • People whose blood test at the screening stage shows a positive result for a specific antibody called anti-SSA/Ro-60.
  • People whose blood test shows a protein called IgG at a level of 16 g/L or higher.
  • People who have not taken hormones, immunosuppressants, biological medicines, or similar treatments in the 4 weeks before screening.
  • Women whose pregnancy test result is negative at screening, and who agree to use effective contraception throughout the trial.
  • People who have not taken part in any other drug trial in the 12 weeks before joining.

Who may not be able to join:

  • Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
  • People who have another connective tissue disease alongside their Sjögren's syndrome.
  • People who have or have had a cancer diagnosis.
  • People with a mental illness, a history of alcohol or drug/substance misuse, a weakened immune system, or an infection that is not under control.
  • People whose condition requires additional strong medications to manage, or who have serious involvement of major organs — such as the heart, liver, kidneys, lungs, or blood — with specific abnormal test results in those areas (confirm with trial site for exact thresholds).
  • People who have lesions affecting the back of the eye or visual field.
  • People who have a known allergy to any ingredient in the study medicines (IGU and/or HCQ).
  • People whom the trial investigator considers unsuitable for the study for any reason.

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 28 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

Principal Investigator: Yongmei Han, Sir Run Run Shaw Hospital

Phone: 13858121751

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 4
Registry
ClinicalTrials.gov
Start date
14 January 2022
Est. completion
1 December 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The change of SSRI-30 between the two groups at 24 weeks

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: 28 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