Study for efficacy and safety of switching treatment from ENBREL to etanercept biosimilar

Study for efficacy and safety of switching treatment from ENBREL to etanercept biosimilar - Observational study for registration data of switching to etanercept biosimilar

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000032633

Enrollment

200

Registered

2018-05-30

Start date

2018-05-30

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.Rheumatoid arthritis patients 2.RA activity maintained low disease or remmison over 12 weeks treated with ENBREL 3.informed consent for treatment with etanrcept BS

Exclusion criteria

Exclusion criteria: RA activity not maintained low disease treateted with ENBREL

Design outcomes

Primary

Measure	Time frame
DAS-28-CRP at week 12	—

Secondary

Measure	Time frame
DAS28-CRP at week 24 and week 52 ESR at week12, week 24 and week52 each components of DAS28 at week21, week 24 and week 52 DAS28-CRP for recurrence of RA patients compatibility after switcning BS variation at week12 adverse events	—

Countries

Japan

Contacts

Public ContactKeiko Funahashi

Matsubara Mayflower Hospital Pharmacy

k-funahashi@mayflower-hp.jp0795-42-8851

Outcome results