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

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 30, 2011

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: 1
  • Placebo Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

  • 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)].

Secondary Measures

  • 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)
  • 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.
  • 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.
  • 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
  • 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
  • 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).
  • 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)].
  • 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)].

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 69 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eisai Co., Ltd.
  • Collaborator
    • FUJIFILM Toyama Chemical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kota Nagai, Study Director, JAC PCU. EPCS, Eisai Co., Ltd.

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