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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

T-614

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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)].

Secondary Outcome Measures

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)

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.

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.

Change From Baseline in C-reactive Protein (CRP)

Assessment of individual ACR core components i.e. CRP

Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

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)

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

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

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)].

Full Information

NCT ID

NCT00965757

First Posted

August 25, 2009

Last Updated

December 8, 2021

Sponsor

Eisai Co., Ltd.

Collaborators

FUJIFILM Toyama Chemical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00965757

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

July 31, 2009 (Actual)

Primary Completion Date

September 30, 2011 (Actual)

Study Completion Date

September 30, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eisai Co., Ltd.

Collaborators

FUJIFILM Toyama Chemical Co., Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

253 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Title

2

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

T-614

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

Change From Baseline in Tender Joint Counts and Swollen Joint Counts

Description

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

Time Frame