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

December 8, 2021 updated by: Eisai Co., Ltd.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
      • Gifu, Japan
      • Hiroshima, Japan
      • Kagashima, Japan
      • Kagoshima, Japan
      • Kochi, Japan
      • Kumamoto, Japan
      • Kyoto, Japan
      • Nagano, Japan
      • Nagasaki, Japan
      • Oita, Japan
      • Osaka, Japan
      • Saitama, Japan
      • Shizuoka, Japan
      • Tokushima, Japan
    • Aichi
      • Anjo, Aichi, Japan
      • Ichinomiya, Aichi, Japan
      • Nagoya, Aichi, Japan
      • Okazaki, Aichi, Japan
      • Toyohashi, Aichi, Japan
    • Chiba
      • Ichikawa, Chiba, Japan
      • Matsudo, Chiba, Japan
      • Narita, Chiba, Japan
    • Fukuoka
      • Kitakyusyu, Fukuoka, Japan
      • Kurume, Fukuoka, Japan
    • Gunma
      • Maebashi, Gunma, Japan
      • Takasaki, Gunma, Japan
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
      • Chitose, Hokkaido, Japan
      • Hakodate, Hokkaido, Japan
      • Sapporo, Hokkaido, Japan
      • Tomakomai, Hokkaido, Japan
    • Hyogo
      • Amagasaki, Hyogo, Japan
      • Kato, Hyogo, Japan
      • Kobe, Hyogo, Japan
    • Ibaraki
      • Hitachi, Ibaraki, Japan
      • Hitachinaka, Ibaraki, Japan
      • Tsukuba, Ibaraki, Japan
    • Ishikawa
      • Kanazawa, Ishikawa, Japan
      • Komatsu, Ishikawa, Japan
    • Iwate
      • Morioka, Iwate, Japan
    • Kagoshima
      • Kirishima, Kagoshima, Japan
    • Kanagawa
      • Kawasaki, Kanagawa, Japan
      • Yokohama, Kanagawa, Japan
    • Kumamoto
      • Tamana, Kumamoto, Japan
    • Miyagi
      • Miyagi-gun, Miyagi, Japan
      • Sendai, Miyagi, Japan
    • Miyazaki
      • Hyuga, Miyazaki, Japan
    • Nagasaki
      • Isahaya, Nagasaki, Japan
      • Sasebo, Nagasaki, Japan
    • Nara
      • Ikoma, Nara, Japan
    • Osaka
      • Higashiosaka, Osaka, Japan
      • Hirakata, Osaka, Japan
      • Takatsuki, Osaka, Japan
    • Saitama
      • Hiki-gun, Saitama, Japan
      • Iruma, Saitama, Japan
      • Kawaguchi, Saitama, Japan
      • Tokorozawa, Saitama, Japan
    • Shimane
      • Matsue, Shimane, Japan
    • Tochigi
      • Nasushiobara, Tochigi, Japan
      • Oyama, Tochigi, Japan
      • Shimotsuke, Tochigi, Japan
    • Tokushima
      • Yoshinogawa, Tokushima, Japan
    • Tokyo
      • Chiyoda, Tokyo, Japan
      • Edogawa, Tokyo, Japan
      • Otaku, Tokyo, Japan
      • Setagaya, Tokyo, Japan
      • Sumida, Tokyo, Japan
    • Toyama
      • Takaoka, Toyama, Japan
      • Tonami, Toyama, Japan
    • Yamagata
      • Yonezawa, Yamagata, Japan
    • Yamaguchi
      • Hofu, Yamaguchi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: T-614
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.
Placebo Comparator: 2
Drug: Placebo
Placebo is administered twice daily in combination with methotrexate. In placebo group, patients will receive T-614 after completing 28 weeks of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of American College of Rheumatology [ACR] 20 Criteria Responders
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)
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)].
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 Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Tender Joint Counts and Swollen Joint Counts
Time Frame: 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)
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
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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).
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
Time Frame: 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)].
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
Time Frame: 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)].
Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Collaborators

FUJIFILM Toyama Chemical Co., Ltd.

Investigators

  • Study Director: Kota Nagai, JAC PCU. EPCS, Eisai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2009

Primary Completion (Actual)

September 30, 2011

Study Completion (Actual)

September 30, 2011

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

August 25, 2009

First Posted (Estimate)

August 26, 2009

Study Record Updates

Last Update Posted (Actual)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 8, 2021

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T614-ADN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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