Keep persistent efficacy by Abstaining from biological treatment after Numerical SDAI remission with AdalImumab (KANSAI study)

Keep persistent efficacy by Abstaining from biological treatment after Numerical SDAI remission with AdalImumab (KANSAI study) - Keep persistent efficacy by Abstaining from biological treatment after Numerical SDAI remission with AdalImumab (KANSAI study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011520

Enrollment

Registered

2013-08-19

Start date

2013-06-07

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 achieve remission and maintain, ADA is step down and step out over the 104 weeks (arm A) After achieve remission and maintain, Maintenance of previous does with ADA treatment over the 52 wee

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient of RA with Adalimumab treatment that maintain remission (SDAI<=3.3) of twice over the 24 weeks

Exclusion criteria

Exclusion criteria: Patient who using other biologic DMARDs and investigational product. Patient who treating with LCAP.

Design outcomes

Primary

Measure	Time frame
Proportion of patients with biologic free remission at week 52	—

Secondary

Measure	Time frame
1. Period until bio-free of tapering and stopping arm 2. Proportion of patients with bio-free and the maintain rate 3. Disease activity(DAS,SDAI), mTSS, HAQ at week 26, 52 and 104(after ADA free at week 0, 26, 52 and 104)	—

Countries

Japan

Contacts

Public ContactAihiro Yamamoto

Kyoto Prefectural University of Medicine Inflammation and Immunology

075-251-5505

Outcome results

None listed

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