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The efficacy and safety of early biological therapy for patients with poor prognosis rheumatoid arthritis

The efficacy and safety of early biological therapy for patients with poor prognosis rheumatoid arthritis: A multi-center, prospective observational study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111868
Enrollment
Unknown
Registered
2025-11-06
Start date
2025-11-30
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

The delayed combination group of Glucocorticoids and Abatacept:None
Glucocorticoids combined with Abatacept group:None

Sponsors

Beijing Friendship Hospital ,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patient meets the 2010 ACR/EULAR classification criteria for RA; 2. Male or female aged 18 years or older, younger than 75 years; disease duration not exceeding 2 years. 3. If using non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics, the patient must have been on a stable dose for at least 2 weeks before enrollment; if not using corticosteroids, the patient must not have taken oral corticosteroids for at least 2 weeks prior to enrollment. 4. The patient has active disease and at least one poor prognostic factor, as follows: swollen joint count (SJC) >=6, tender joint count (TJC) >=6; ESR >=28 mm/h; CRP >=20 mg/L; serum anti-CCP antibody >10^2 IU/ml; imaging shows >=1 bone erosion, diffuse joint space narrowing, or bone marrow edema. 5. Understand the observational procedures and content, and voluntarily sign the informed consent form to agree to cooperate and participate in the trial.

Exclusion criteria

Exclusion criteria: 1. Known active infections that are currently uncontrolled, such as tuberculosis infection, viral hepatitis, etc.; 2. Patients with severe, progressive, uncontrolled major organ and system diseases (such as class III heart failure, severe liver or kidney dysfunction), or other conditions deemed by the attending physician as unsuitable for participation in this study; 3. Patients who have previously received RA-related targeted therapy after diagnosis; 4. Patients who received intra-articular, intramuscular, or intravenous glucocorticoid treatment within 4 weeks prior to the first study drug administration; those whose oral glucocorticoid dose was not stabilized for at least 4 weeks, and whose dose was not stabilized to <=10 mg prednisone/day before the first study drug administration; 5. Female patients who are pregnant or breastfeeding, become pregnant, are breastfeeding, plan to become pregnant, or have fertility requirements during the study or within 3 months after the study; 6. Patients assessed by a physician to have latent tuberculosis infection or risk of hepatitis B virus reactivation and who cannot receive prophylactic antiviral therapy; 7. Patients with psychiatric disorders or intellectual disabilities.

Design outcomes

Primary

MeasureTime frame
The proportion of patients in both groups achieving ACR50 remission at 24 weeks;

Countries

China

Contacts

Public ContactYanying Liu

Beijing Friendship Hospital ,Capital Medical University

57495011@qq.com+86 10 63139771

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026