Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state

Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041200048

Enrollment

Registered

2020-10-02

Start date

2021-01-14

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

1) MTX* - Continued group: Continued at a stable dose and interval throughout the cours of the study. Folic acid is continued if concomitantly used. - Withdrawn group: Week 0 to 12 Reduced after regi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients fulfilled the 1987 ACR classification criteria or the new ACR/EULAR diagnostic criteria for RA 2) RA patients with sustained low disease activity (CDAI =12 weeks while undergoing combination therapy with CZP plus MTX 3) RA patients receiving CZP, MTX, csDMARDs, and glucocorticoids at a stable dosage regimen for >=12 weeks prior to obtaining informed consent 4) RA patients aged >=20 years 5) Obtaining written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with adherence problems 2) Patients judged as inadequate at the discretion of inevstigators

Design outcomes

Primary

Measure	Time frame
Proportion of patients maintaining low disease activity without a flare* at week 36 (24 weeks after MTX discontinuation). *Disease flare is defined as a CDAI score >10 or intervention with the rescue treatments for any reason.	—

Secondary

Measure	Time frame
1) Proportion of patients maintaining low disease activity evaluated with CDAI at week 12, 24, and 52 2) Proportion of patients maintaining clinical remission evaluated with CDAI at week 0, 12, 24, 36, and 52 3) Following parameters from week 0 to 52 - CDAI, SDAI, DAS28-CRP, J-HAQ - CRP, MMP-3 - FSSG, EQ-5D 4) Changes of following parameters from week 0 to 52 - Total Sharp score - Atlantodental interval 5) Proportion of patients with structural remission and clinically relevant radiographic progression at week 52 6) Rate of regaining low disease activity in patients with CDAI>10 7) Predictors of maitaining low disease activity, structural remission, and clinically relevant radiographic progression 8) Adverse events	—

Measure

Time frame

1) Proportion of patients maintaining low disease activity evaluated with CDAI at week 12, 24, and 52 2) Proportion of patients maintaining clinical remission evaluated with CDAI at week 0, 12, 24, 36, and 52 3) Following parameters from week 0 to 52 - CDAI, SDAI, DAS28-CRP, J-HAQ - CRP, MMP-3 - FSSG, EQ-5D 4) Changes of following parameters from week 0 to 52 - Total Sharp score - Atlantodental interval 5) Proportion of patients with structural remission and clinically relevant radiographic progression at week 52 6) Rate of regaining low disease activity in patients with CDAI>10 7) Predictors of maitaining low disease activity, structural remission, and clinically relevant radiographic progression 8) Adverse events

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Contacts

Public ContactMochihito Suzuki

Nagoya University Hospital

asai@med.nagoya-u.ac.jp+81-52-744-1908

Outcome results

None listed

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