A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: T-614; Drug: Placebo

• Registration Number: NCT00965757
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of T-614 versus placebo when added to ongoing, stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-31
• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-25
• Study First Posted: 2009-08-26
• Primary Completion: 2011-09-30
• Study Completion: 2011-09-30
• Results First Submitted: 2014-08-08
• Results First Submitted QC: 2015-06-15
• Results First Posted: 2015-06-19
• Status Verified: 2015-11
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	T-614	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of American College of Rheumatology [ACR] 20 Criteria Responders	Week 24 Last Observation Carried Forward (LOCF) (for T-614 arm and placebo arm) and Week 52 LOCF (for T-614 arm and placebo/T614 arm)	ACR20 response is defined as at least a 20% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant \[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\].

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Tender Joint Counts and Swollen Joint Counts	Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)	Assessment of individual ACR core components like Tender Joint Counts (TJC) and Swollen Joint Counts (SJC)
Change From Baseline in PAP, PtGADA and PyGADA	Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)	Patient's assessment of pain (PAP), patient's global assessment of disease activity (PtGADA) and physician's global assessment of disease activity (PyGADA) each was assessed on a visual analog scale ranging from 0-100 mm, with higher scores indicating severe disease.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)	Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)	HAQ-DI was a participant assessed measure of health assessment, measured on a single scale ranging from 0 (no difficulty) to 3 (unable to do), with higher scores indicating severe disease.
Change From Baseline in C-reactive Protein (CRP)	Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)	Assessment of individual ACR core components i.e. CRP
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)	Assessment of individual ACR core components i.e. ESR
Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2)	Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)	The DAS28 is a composite score derived from 4 of these measures i.e count of 28 swollen joints, 28 tender joints, measure erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) and to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). DAS28 is assessed as score on scale from 0 to 10 indicating current rheumatoid arthritis (RA) disease activity (0= low disease activity and 10 = high disease activity).
Percentage of ACR 50 Criteria Responders	Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)	ACR50 response is defined as at least a 50% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant \[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\].
Percentage of ACR 70 Criteria Responders	Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)	ACR70 response is defined as at least a 70% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant \[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\].