Phase 1 Rheumatoid Arthritis Trial, Recruiting NCT05197530 Sponsor: University of Rochester Condition: Rheumatoid Arthritis
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Phase 1 Rheumatoid Arthritis Trial, Recruiting

NCT05197530
Recruiting Phase 1

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:

For people with early rheumatoid arthritis (RA):

  • People who are able to give written consent to participate
  • People aged 18 or older
  • People who have been diagnosed with rheumatoid arthritis according to 2010 ACR criteria, with a disease activity score (DAS28-CRP) above 3.5, indicating moderate-to-high disease activity
  • People who have had rheumatoid arthritis for 1 year or less
  • People whose RA has not responded well enough to methotrexate treatment (still showing disease activity after 4 months), OR people who have had a flare-up while on methotrexate AND who are starting an anti-TNF therapy (a type of biologic medication)
  • People who have confirmed active joint inflammation in one or both hands, shown by ultrasound

For people with established rheumatoid arthritis (RA):

  • People who are able to give written consent to participate
  • People aged 18 or older
  • People who have been diagnosed with rheumatoid arthritis according to 2010 ACR criteria, with a disease activity score (DAS28-CRP) above 3.5
  • People who have had rheumatoid arthritis for at least 10 years
  • People who have confirmed active joint inflammation in one or both hands, shown by ultrasound
  • People who have been on a stable dose of a DMARD medication (such as methotrexate, leflunomide, azulfidine, or hydroxychloroquine), a JAK inhibitor, or a biologic medication for at least 8 weeks

Who may not be able to join:

  • People who have other active systemic or inflammatory conditions besides rheumatoid arthritis, including chronic infections such as hepatitis B, hepatitis C, or HIV
  • People who have a known allergy or sensitivity to iodine, due to a small amount of iodine present in a substance used in the study (Indocyanine Green)
  • People who are pregnant
  • People who are unable to have blood drawn due to poor vein access

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 8 July 2026
Phase 1: approximately ~10% 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

Principal Investigator: Christopher Ritchlin, MD, MPH, University of Rochester

Phone: 585-275-1634

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 1
Registry
ClinicalTrials.gov
Start date
30 December 2021
Est. completion
1 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Clearance

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: 8 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