Discontinuation of adalimumab without functional and structural damage progression after attaining sustained remission in patients with rheumatoid arthritis: An observational study

Discontinuation of adalimumab without functional and structural damage progression after attaining sustained remission in patients with rheumatoid arthritis: An observational study - HUMIRA discontinuation withOut functional and radiographic damage progressioN follOwing sustained Remission in rheumatoid arthritis (HONOR study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000006669

Enrollment

Registered

2011-11-05

Start date

2009-02-01

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosed as rheumatoid arthritis, 2) sustained remission >24 weeks

Exclusion criteria

Exclusion criteria: 1) Use of glucocorticoids for 24 weeks prior to discontinuation of adalimumab, 2) use of NSAIDs for 24 weeks prior to discontinuation of adalimumab, 3) severe infection, 4) active tuberculosis, 5) demyelinating disease (multiple sclerosis), 6) congestive heart failure, 7) Patient who is lactating, pregnant, possibly pregnant or do not agree with anti-conception during the trial and 6 months after the last administration of adalimumab, 8) patients who are inadequate to enter this trial due to the other reasons as judged by investigators

Design outcomes

Primary

Measure	Time frame
The percentage of patients who maintained remission status at 24 weeks after discontinuation of adalimumab	—

Secondary

Measure	Time frame
Percentages of patients who maintained low disease activity (DAS28-ESR <3.2), remission (DAS28-ESR <2.6), normal function (HAQ <0.5) and no structural damage (1-year change of mTSS <0.5) at 24/52 weeks after discontinuation of adalimumab	—

Countries

Japan

Contacts

Public ContactAyako Yamaguchi

University of Occupational and Environmental Health, Japan The First Department of Internal Medicine, School of Medicine

ayasuzu@med.uoeh-u.ac.jp093-603-1611

Outcome results