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Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity

Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity - CROWN study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071190001
Enrollment
150
Registered
2019-04-02
Start date
2019-08-29
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

Patients retaining LDA with the combination of CZP and MTX are randomized to two groups consisting of patients who continue MTX at the same doses or discontinue MTX. The effects of both groups are com

Sponsors

Miyazaki Yusuke
Lead Sponsor
Tanaka Yoshiya
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients aged over 16 years (at the time of informed consent) 2) Patients diagnosed with rheumatoid arthritis (RA) under the 1987 American College of Rheumatology (ACR) or 2010 ACR/European League Against Rheumatism (EULAR) criteria 3) Patients who have been receiving combination therapy with MTX ( over 6 mg/week) and CZP for 24 weeks before enrollment of the study 4) Patients who showed SDAI less than 11 at any visit for over 3 months before enrollment without taking any steroids 5) Patients who provided written informed consent

Exclusion criteria

Exclusion criteria: Patients judged by the investigator to be unsuitable for participants in the study

Design outcomes

Primary

MeasureTime frame
Percentage of patients with SDAI less than 11 at 12, 24, and 52 weeks after starting the study

Secondary

MeasureTime frame
SDAI remission rate at 52 weeks after starting the study DAS28-ESR remission rate at 52 weeks after starting the study Duration of protocol therapy Change from baseline in the mTSS at 52 weeks after starting the study

Contacts

Public ContactYusuke Miyazaki

Hospital of the University of Occupational and Environmental Health, Japan

yuppy0316@med.uoeh-u.ac.jp+81-93-603-1611

Outcome results

None listed

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