Research for establishment and validation of therapeutic guideline aiming at "treatment holiday" in rheumatoid arthritis

Research for establishment and validation of therapeutic guideline aiming at "treatment holiday" in rheumatoid arthritis - FREE-J study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000014856

Enrollment

500

Registered

2014-09-01

Start date

2014-12-01

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) Patient diagnosed as having rheumatoid arthritis according to ACR 1987 revised classification criteria for rheumatoid arthritis or ACR/EULAR 2010 revised classification criteria for rheumatoid arthritis. (2) Patient maintained stable DAS28(ESR) remission at least 2 consecutive visits under treatment with biological DMARD and concomitant MTX (8mg/week). (3) Patient;18 year-old with written informed consent for participating in the study.

Exclusion criteria

Exclusion criteria: (1) Patient with contraindication to MTX. (2) Patient with contraindication to biological DMARD. (3) Patient with any other reasons for inadequate to participate in this study, judege by attending rheumatologist.

Design outcomes

Primary

Measure	Time frame
DAS28(ESR) remission rate at 1 year after discontinuing biological DMARD	—

Countries

Japan

Contacts

Public ContactAyako Yamaguchi

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

ayasuzu@med.uoeh-u.ac.jp+81-93-603-1611

Outcome results