Restart for sustaining remission of rheumatoid arthritis in use of etanercept

Restart for sustaining remission of rheumatoid arthritis in use of etanercept - RESUME

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008164

Enrollment

Registered

2012-06-13

Start date

2011-02-01

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

After the administration of etanercept (50mg/week), the dosage of etanercept will be discontinued when the low disease activity (DAS28-ESR&lt

3.2) is achieved. If patients recur from low disease activity, same dose of etanercept will be administered again by the observation of every two months. This strategy will be maintained for two years

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The patients who meet 2010 ACR/EULAR classification criteria 2. The patients receiving MTX more than three months 3. The patients with moderate or severe disease activity (DAS28-ESR>3.2)

Exclusion criteria

Exclusion criteria: 1. The patients with severe joint destruction of hands and feet because the evaluation of Sharp score will be impossible 2.The patients who take tacrolimus 3.The patients receiving glucocorticoid over 5mg/day

Design outcomes

Primary

Measure	Time frame
The rate of change of modified Sharp score at 24 months	—

Secondary

Measure	Time frame
1. The rate of change of DAS28 at 24 months 2. The rate of change of modified HAQ at 24 months 3. Safety profile	—

Countries

Japan

Contacts

Public ContactTatsuya Tatsuya Koike

Osaka City University Medical School Rheumatosurgery

tatsuya@med.osaka-cu.ac.jp+81-6-6645-3984

Outcome results

None listed

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