PRECIOUS-B study

JRCT ID: jRCT1041190125

Registered date:09/03/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 09/03/2020
• Target sample size: 51
• Study type: Interventional

Intervention(s)

1) MTX*
Week 0 to 12
- Reduced after registration.
- The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose.
- The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose 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) BAR
- Continued at a stable dose and interval throughout the course of the study.

3) csDMARDs other than MTX
- Continued at a stable dose and interval throughout the course of the study.

4) Glucocorticoids
- Continued at a stable dose up to week 36, and allowed to taper after week 36.

5) Rescue treatments
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
- Changing the dosing frequency back to weekly administration, 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 low disease activity evaluated with SDAI, DAS28-CRP, and DAS28-ESR at week 0, 12, 24, 36, and 52
3) Proportion of patients maintaining remission evaluated with CDAI, SDAI, DAS28-CRP, and DAS28-ESR at week 0, 12, 24, 36, and 52
4) Following parameters from week 0 to 52
- CDAI, SDAI, DAS28-CRP, DAS28-ESR, J-HAQ
- CRP, ESR, MMP-3
- FSSG, EQ-5D, SF-36, FACIT fatigue
5) Change from week 0 to 52 in total Sharp score
6) Proportion of patients with structural remission and clinically relevant radiographic progression at week 52
7) Rate of regaining low disease activity in patients with CDAI>10
8) Predictors of maitaining low disease activity, structural remission, and clinically relevant radiographic progression
9) 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 BAR plus MTX
3) RA patients receiving BAR, 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
• Source(s) of Monetary Support: Nagoya University Hospital