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Discontinuation of biological agents without functional and structural damage progression after attaining sustained remission in patients with rheumatoid arthritis

Discontinuation of biological agents without functional and structural damage progression after attaining sustained remission in patients with rheumatoid arthritis - KINKI STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022596
Enrollment
110
Registered
2016-10-01
Start date
2016-10-15
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Rheumatoid Arthritis

Interventions

Use of Biological agents

Sponsors

Department of Hematology and Rheumatology, Kinki University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Diagnosed by the criteria of 2010 ACR/EULAR with RA 2) The patients who sustained the remission (DAS28 < 2.6) at least 6 months

Exclusion criteria

Exclusion criteria: 1) The patients who refused to join this study.2) The patients who prescribed up-dose in DMARDS, steroids, and NSAIDs and done the joint injection 3) severe infection 4) demyelinating disease (multiple sclerosis), 5) congestive heart failure, 6) Patient who is lactating, pregnant, possibly pregnant or do not agree with the study.

Design outcomes

Primary

MeasureTime frame
At 6 monhs after discontinuation of biological agents, the estimation in DAS28, CDAI, and SDAI with the RA patients who achieved the remission.

Secondary

MeasureTime frame
1) Radiograghic X ray (modified Sharp score) 2) Ultrasonography (synovitis; Gray Scale and Power Doppler) 3) Health assessment questionare score (HAQ) 4) Patients character (Age, Sex, Disease duration, Stage, Class) 5) Biomarker (CRP, ESR, RF, anti-CCP Ab)

Countries

Japan

Contacts

Public ContactYuji Nozaki

Department of Hematology and Rheumatology, Kinki University School of Medicine Department of Hematology and Rheumatology

yuji0516@med.kindai.ac.jp0723660221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026