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Completed

NCT Number: NCT00965757

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anjo, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-614

Drug

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

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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).

  7. 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)].

  8. 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)].

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Collaborators

  • FUJIFILM Toyama Chemical Co., Ltd.

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 26, 2009
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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