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NCT07045896
Fucoidan Therapy in Adults With Active Rheumatoid Arthritis and Inadequate Response to Conventional DMARDs: a Multicenter, Single-arm, Open-label, Phase 2 Trial
NA trial testing Fucoidan in Arthritis, Rheumatoid in 40 participants. Currently enrolling.
1 December 2026
Quick facts
| Lead sponsor | Peking University People's Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 10 January 2026 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 July 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Fucoidan — full drug profile →
Conditions studied
- Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →
Sponsor
Peking University People's Hospital
Who can join
Adults 18 to 65, any sex, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The proportion of patients achieving the American College of Rheumatology 20% improvement criteria (ACR20) at Week 12.
Time frame: at Week 12
The ACR20 criteria for evaluating the condition are: a 20% or greater improvement in the number of tender joints compared to baseline, a 20% or greater improvement in the number of swollen joints, and a 20% or greater improvement in three of the following five core indicators: A) the patient's overall assessment of disease activity, B) the physician's overall assessment of disease activity, C) the
Sponsor's own description
Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by joint destruction and autoantibody production. Scavenger receptor-A (SR-A), a pattern recognition receptor primarily expressed on myeloid-derived cells, is significantly elevated in the serum of RA patients. Genetic knockout of SR-A completely protects mice from collagen-induced arthritis (CIA). As an SR-A inhibitor, fucoidan markedly suppresses the progression of CIA in mice. Given the potential role of SR-A in RA pathogenesis, the investigators hypothesize that fucoidan may exert therapeutic effects in RA by specifically targeting human SR-A. This study aims to investigate the efficacy of fucoidan in RA treatment through a multicenter, single-arm, open-label trial, providing original insights into its clinical application. The investigators plan to enroll 40 patients with a 12-week follow-up period. Clinical manifestations, laboratory parameters, and disease activity will be systematically evaluated to assess therapeutic outcomes. The findings will provide evidence-based medical data for RA treatment strategies.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07045896
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Other recruiting trials for Arthritis, Rheumatoid
Currently open trials in the same condition.
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Other Peking University People's Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07045896 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University People's Hospital
- Last refreshed: 14 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07045896.
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