T-ReX study

JRCT ID: jRCTs041180071

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 13/10/2016
• Target sample size: 51
• Study type: Interventional
• Intervention(s): At week 0, the dosing frequency of MTX was decreased from weekly to biweekly without a change in dose, regardless of the initial dose. At week 12, MTX was discontinued if low disease activity was maintained. TCZ and csDMARDs other than MTX were continued at a stable dose and interval throughout the course of the study. Glucocorticoids were continued at a stable dose up to week 36, and allowed to taper after week 36. The use of oral analgesics (non-steroidal anti-inflammatory drugs, acetaminophen, pregabalin, and tramadol) was not prohibited during the study period. One or more of the following rescue treatments were 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 or glucocorticoids; and administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.

Outcome(s)

• Primary Outcome: The proportion of patients maintaining low disease activity without a flare at week 36 (24 weeks after MTX discontinuation)

Secondary Outcome

1) The proportion of patients maintaining low disease activity without a flare at week 12 and 64
2) The following parameters from week 0 to 64: disease activity (CDAI, SDAI, and DAS28-CRP), serum MMP-3 level, physical function (HAQ-DI), quality of life (EQ-5D), and GI symptoms (FSSG; prevalence of GERD was defined as a FSSG score >=8).
3) 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) Patients who had a serum C-reactive protein (CRP) level of >=0.6 mg/dL at the time of initiating TCZ therapy
3) Patients with sustained low disease activity (CDAI <=10) for >=12 weeks while undergoing combination therapy with TCZ plus MTX
4) Patients had to be receiving MTX orally at a stable dose of >=6 mg/week, and TCZ at a stable dosage regimen irrespective of the route of administration, for >=12 weeks prior to obtaining informed consent. Patients receiving conventional synthetic DMARDs (csDMARDs) other than MTX or glucocorticoids were eligible, but doses had to be stable for >=12 weeks prior to obtaining informed consent

Exclude criteria

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

Related Information

• Primary Sponsor: Kojima Toshihisa
• Source(s) of Monetary Support: Chugai Pharmaceutical Co., Ltd.
• Secondary ID(s): UMIN000021247