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

This study has been completed.
Sponsor:
Collaborator:
Toyama Chemical Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00965757
First received: August 25, 2009
Last updated: November 19, 2015
Last verified: November 2015
  Purpose
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

Condition Intervention Phase
"Rheumatoid Arthritis"
Drug: T-614
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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)].


Enrollment: 253
Study Start Date: July 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 69 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965757

  Show 72 Study Locations
Sponsors and Collaborators
Eisai Co., Ltd.
Toyama Chemical Co., Ltd.
Investigators
Study Director: Kota Nagai JAC PCU. EPCS, Eisai Co., Ltd.
  More Information

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT00965757     History of Changes
Other Study ID Numbers: T614-ADN 
Study First Received: August 25, 2009
Results First Received: August 8, 2014
Last Updated: November 19, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 24, 2016