T-ReX study

Not Applicable

• Conditions: Rheumatoid arthritis

• Registration Number: JPRN-jRCTs041180071
• Lead Sponsor: Kojima Toshihisa

Brief Summary

Discontinuation of concomitant methotrexate is clinically feasible for maintaining low disease activity, and may be beneficial from the perspective of reducing gastrointestinal symptoms in Japanese RA patients treated with tocilizumab.

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-11-15
• Study Start: 2019-03-07
• Results First Posted: 2019-08-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1) The proportion of patients maintaining low disease activity without a flare at week 12 and 64<br>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).<br>3) Adverse events