T-ReX study

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs041180071
• Date of registration: 07/03/2019
• Prospective Registration: No
• Primary sponsor: Kojima Toshihisa
• Public title: T-ReX study
• Scientific title: Tocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study
• Date of first enrolment: 13/10/2016
• Target sample size: 51
• Recruitment status: Complete
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs041180071
• Study type: Interventional
• Study design: single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose
• Phase: N/A

Contacts

• Name: Shuji Asai
• Affiliation: Ngoya University Hospital

• Name: Toshihisa Kojima
• Affiliation: Ngoya University Hospital

Key inclusion & exclusion criteria

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

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

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

UMIN000021247

Source(s) of Monetary Support

Chugai Pharmaceutical Co., Ltd.

Ethics review

Status: Approval
Approval date: 04/02/2019
Contact:

[e-mail]

Nagoya University Certified Review Board

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 02/07/2020
• Date Completed: 15/11/2018
• URL: https://doi.org/10.1080/14397595.2019.1641934