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

JRCT ID: jRCTs041200048

Registered date:02/10/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 02/10/2020
• Target sample size: 88
• Study type: Interventional

Intervention(s)

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- Withdrawn group: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 registration.
The dose of MTX is reduced to half, regardless of the initial dose.
Folic acid is continued if concomitantly used.
Week 12 to 52
Discontinued if low disease activity was maintained.
Folic acid is discontinued if concomitantly used.
*The allowable range of adherence is -20% to +20%.

2) CZP and csDMARDs other than MTX
Continued at a stable dose and interval throughout the course of the study in both groups.

3) Glucocorticoids
Continued at a stable dose up to week 36, and allowedto taper after week 36 in both group.

4) Rescue treatment
One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request.
- Restoring, restarting, or increasing doses of MTX
- Increasing doses of or adding csDMARDs other than MTX.
- Increasing doses of or adding glucocorticoids
- Drainage of synovial fluid.
- Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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 <=10) for >=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

Exclude criteria

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

Related Information

• Primary Sponsor: Asai Shuji
• Secondary Sponsor: Kojima Toshihisa
• Source(s) of Monetary Support: Astellas Pharma Inc.