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Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment

Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment - PROUD study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010315
Enrollment
50
Registered
2013-03-26
Start date
2012-10-01
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

In patients with clinical remission by adalimumab (DAS28-CRP &lt
2.6) maintained over 24 weeks, to stop the Adalimumab.

Sponsors

Osaka City University Medical School
Lead Sponsor
Metabolism, Endocrinology, and Molecular Medicine. Osaka City University Graduate School of Medicine. The center for rheumatic diseases. Nara Medical University. Rheumatology. Kitano Hospital.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: RA patients fulling the American Rheumatology Association criteria 1987 and ACR/EULAR classification cliteria 2010. The patients using adalimumab who have stable remission, as a 28-joint disease activity score CRP (DAS28-CRP) <2.6 for at least 24 weeks.

Exclusion criteria

Exclusion criteria: Patients with other diseases that can affect the infllamation state. Patients using corticosteroids exceeding 5mg/day. Patients who was deemed inappropriate by test doctor to participate in this study.

Design outcomes

Primary

MeasureTime frame
Consider the possible state by results of ultrasound in the presence or absence of recurrence (DAS28-CRP <3.2) at week 24 after discontinuation of Adalimumab.

Secondary

MeasureTime frame
Consider the possible state by results of ultrasound in the presence or absence of recurrence (DAS28-CRP <3.2) at week 52 after discontinuation of Adalimumab. the change of X-ray from baseline in the van der Heijde-Sharp score at week 24 and 52. the change of ultrasound results from baseline at week 24and 52

Countries

Japan

Contacts

Public ContactTadashi Okano

Osaka City University Medical School Orthopedic Surgery

ma1sa3ru@med.osaka-cu.ac.jp0666453851

Outcome results

None listed

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