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

Eisai Co., Ltd.253 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

253

Conditions

Rheumatoid Arthritis

Interventions

T-614DRUG

T-614 is administered twice daily in combination with methotrexate. The daily dose of T-614 is 25 mg for the first 4 weeks and 50 mg for subsequent weeks.

PlaceboDRUG

Placebo is administered twice daily in combination with methotrexate. In placebo group, patients will receive T-614 after completing 28 weeks of treatment.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 69 Years

Medical Language ↔ Plain English

Inclusion criteria: * Subjects who have a diagnosis of Rheumatoid Arthritis by the ACR criteria * Age greater or 20 years and less than 70 years old Exclusion criteria: * Subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study * Women of childbearing potential who are not practicing a successful method of contraception, or wish to become pregnant

Locations (72)

Outcomes

Primary Outcomes

Percentage of American College of Rheumatology [ACR] 20 Criteria Responders

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 \[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\].

Time frame: 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)

Secondary Outcomes

Change From Baseline in Tender Joint Counts and Swollen Joint Counts

Assessment of individual ACR core components like Tender Joint Counts (TJC) and Swollen Joint Counts (SJC)

Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)

Change From Baseline in PAP, PtGADA and PyGADA

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.

Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)

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.

Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)

Change From Baseline in C-reactive Protein (CRP)

Assessment of individual ACR core components i.e. CRP

Data from ClinicalTrials.gov

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Unnamed facility

Anjo, Aichi-ken, Japan

Unnamed facility

Ichinomiya, Aichi-ken, Japan

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Okazaki, Aichi-ken, Japan

Unnamed facility

Toyohashi, Aichi-ken, Japan

Unnamed facility

Ichikawa, Chiba, Japan

Unnamed facility

Matsudo, Chiba, Japan

Unnamed facility

Narita, Chiba, Japan

Unnamed facility

Kitakyushu, Fukuoka, Japan

Unnamed facility

Kurume, Fukuoka, Japan

...and 62 more locations

Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)

Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

Assessment of individual ACR core components i.e. ESR

Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)

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)

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).

Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)

Percentage of ACR 50 Criteria Responders

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 \[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\].

Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)

Percentage of ACR 70 Criteria Responders

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 \[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\].

Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)