Rheumatoid Arthritis
Conditions
Interventions
Low dose group:FNS007 60mg, Administered intravenously twice weekly for 12 weeks
High dose group:FNS007 100mg, Administered intravenously twice weekly for 12 weeks
Placebo control :Administered intravenously twice weekly for 12 weeks
Active control:Tofacitinib 5 mg orally twice daily for 12 weeks.
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 70 years (inclusive) at the time of signing the informed consent form, of either sex. 2. Diagnosis of rheumatoid arthritis according to either the 1987 ACR criteria or the 2010 ACR/EULAR classification criteria. 3. Moderate to severe disease activity: DAS28 > 3.2 (DAS28 calculated based on ESR or CRP/hsCRP). 4. Tender joint count (TJC, based on 68 joints) >= 6 and swollen joint count (SJC, based on 66 joints) >= 6. 5. Inadequate response to methotrexate, having received treatment for >= 3 months prior to screening, and on a stable dose (7.5-25 mg/week) for >= 28 days; if using low-dose oral corticosteroids (prednisone = 28 days. 6. BMI >= 18.5 and <= 30 kg/m². 7. Able to understand and comply with the visit schedule, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. RA patients with functional class IV disease. 2. Presence of high fever, acute or chronic infection, or sepsis unrelated to RA disease progression. 3. Use of biologic DMARDs (bDMARDs) within specified periods prior to randomization: Anakinra: within 28 days before baseline; Etanercept: within 28 days before baseline; Adalimumab, Infliximab: within 56 days before baseline; Golimumab, Certolizumab: within 70 days before baseline; Abatacept, Tocilizumab: within 84 days before baseline; Denosumab: within 150 days before baseline; Rituximab: within 180 days before baseline. 4. Use of targeted synthetic DMARDs (tsDMARDs) such as Tofacitinib, Baricitinib, Upadacitinib, Filgotinib, Peficitinib, etc., within 84 days prior to randomization. 5. Use of conventional synthetic DMARDs (csDMARDs) other than methotrexate within 28 days prior to randomization; use of leflunomide within 56 days prior to randomization, except for patients who have undergone washout with cholestyramine (8g TID) or activated charcoal (50g QID) for =11 days; patients who have undergone washout with cholestyramine (8g TID) or activated charcoal (50g QID) for >=1 and 10 mg/day at randomization; or dose =10 mg/day but with dose adjustment within 4 weeks prior to randomization. 9. Receipt of systemic interferon therapy within 28 days prior to randomization. Current use of strong opioids. 10. Presence of autoimmune diseases other than RA, including but not limited to psoriatic arthritis (PsA), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), or Lyme disease. Secondary Sjögren's syndrome in RA is excluded. Presence of other inflammatory joint diseases other than RA, including but not limited to gout, palindromic rheumatism, etc. 11. History of primary immunodeficiency disease. 12. History of hematological disorders (including hemolytic anemia) and any lymphoproliferative disorders, such as EBV-associated lymphoproliferative disease, lymphoma, leukemia, myeloproliferative disease, multiple myeloma, etc. 13. Presence of or history of malignancy within 5 years. Except for resected carcinoma in situ or non-melanoma skin cell cancer. 14. Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV-Ab), Human immunodeficiency virus antibody (Anti-HIV), or Treponema pallidum antibody (TP-Ab); positive Hepatitis B core antibody (anti-HBc) with a positive HBV-DNA test. 15. Evidence of active tuberculosis (TB); latent tuberculosis infection, defined as tuberculin skin test (PPD) induration >=5mm or positive interferon-gamma release assay (e.g., T-SPOT), without having completed standard prophylactic anti-tuberculosis treatment for at least 4 weeks prior to randomization. 16. Vaccination with any vaccine within 3 months prior to randomization. 17.Blood donation exceeding 400 mL within 28 days prior to randomization. 18. Presence of uncontrolled cardiovascular, respiratory, digestive, endocrine, hematological, neurological
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20 response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR20 response rate;ACR50 response rate;ACR70 response rate;Proportion of patients achieving DAS28 low disease activity (DAS28 = 3.2);Proportion of patients achieving DAS28 remission (DAS28 = 2.6);Change in DAS28 score;Duration of morning stiffness;Tender joint count;Swollen joint count;Patient Global Assessment of Disease Activity;Physician Global Assessment of Disease Activity;Pain VAS Score;HAQ-DI Score;Change in SDAI score;Change in CDAI score;SF-36 Score;FACIT-F Score;Proportion of patients receiving rescue medication;Time to relapse; | — |
Countries
China
Contacts
Public ContactRu Li
Peking University People's Hospital
Outcome results
None listed