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Efficacy and safety of progressively reducing biologic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis in persistent remission: a non-inferiority randomized, controlled, single-blind trial

Efficacy and safety of progressively reducing biologic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis in persistent remission: a non-inferiority randomized, controlled, single-blind trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044751
Enrollment
Unknown
Registered
2021-03-26
Start date
2021-09-01
Completion date
Unknown
Last updated
2021-10-26

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

Conditions

Rheumatoid arthritis

Interventions

Control group:Standard doses
Experimental group:Gradual dose reduction

Sponsors

Gansu Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, no gender limitation; 2. RA patients diagnosed according to the RA classification standard issued by the American College of Rheumatology (ACR) in 1987 and the RA classification standard issued by ACR/EULAR in 2010; 3. Patients treated RA with maintained stable doses of adamu monoantigen, inasip, lytoxides, inflixi monoantigens, etc. during the past 6 months; 4. RA patients who have maintained clinical remission in the past 6 months; 5. Patients with no progress of structural damage to hand, foot and joint X-rays in the past 1 year; 6. Participants participated knowingly and voluntarily and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Current oral glucoticoid therapists; 2. RA patients who have been given corticosteroids or short-term oral glucoticoids in the joints or intestines in the past 6 months; 3. Patients who are addicted to alcohol or drug; 4. Patients with psychological/mental disorders that may invalidate informed consent; 5. Patients who are pregnant, nursing or have a pregnancy plan; 6. Patients with contraindications of bDMARDs maintenance treatment; 7. Patients with malignant tumors or a history of malignant tumors; 8. Patients with other autoimmune diseases; 9. Patients participated in other clinical studies during this trial or within 30 days; 10. Other situations in which the researchers did not consider it appropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
persistent flare;

Secondary

MeasureTime frame
cumulative flare;disease activity during follow-up;physical function;quality of life;imaging performance and imaging progress;the proportion of clinical remission and LDA maintained at the end of the follow-up;the proportion of patients in the observation group who successfully reduced the drug;the proportion of patients in observation group who successfully discontinued the drug;occurrence of adverse events;

Countries

China

Contacts

Public ContactLei Shangwen

Gansu Provincial People's Hospital

1192792959@qq.com+86 18919846059

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026