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

NCT00965757 | Completed Phase 3 Results

• 1 other identifier: T614-ADN
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 72

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 \[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\].

  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 Outcomes (8)

• Change From Baseline in Tender Joint Counts and Swollen Joint Counts

  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

  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)

  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)

  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)

  Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)

Study Arms (2)

1

EXPERIMENTAL

Drug: T-614

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

1

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.

2

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have a diagnosis of Rheumatoid Arthritis by the ACR criteria
• Age greater or 20 years and less than 70 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead
• FUJIFILM Toyama Chemical Co., Ltd.: collaborator

Study Sites (72)

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Anjo, Aichi-ken, Japan

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Ichinomiya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Okazaki, Aichi-ken, Japan

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Toyohashi, Aichi-ken, Japan

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Ichikawa, Chiba, Japan

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Matsudo, Chiba, Japan

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Narita, Chiba, Japan

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Kitakyushu, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Maebashi, Gunma, Japan

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Takasaki, Gunma, Japan

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Asahikawa, Hokkaido, Japan

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Chitose, Hokkaido, Japan

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Hakodate, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Tomakomai, Hokkaido, Japan

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Amagasaki, Hyōgo, Japan

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Katō, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Hitachi, Ibaraki, Japan

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Hitachi-Naka, Ibaraki, Japan

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Tsukuba, Ibaraki, Japan

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Kanazawa, Ishikawa-ken, Japan

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Komatsu, Ishikawa-ken, Japan

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Morioka, Iwate, Japan

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Kirishima, Kagoshima-ken, Japan

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Kawasaki, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Tamana, Kumamoto, Japan

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Miyagi-gun, Miyagi, Japan

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Sendai, Miyagi, Japan

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Hyūga, Miyazaki, Japan

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Isahaya, Nagasaki, Japan

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Sasebo, Nagasaki, Japan

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Ikoma, Nara, Japan

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Higashiosaka, Osaka, Japan

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Hirakata, Osaka, Japan

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Takatsuki, Osaka, Japan

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Hiki-gun, Saitama, Japan

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Iruma, Saitama, Japan

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Kawaguchi, Saitama, Japan

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Tokorozawa, Saitama, Japan

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Matsue, Shimane, Japan

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Nasushiobara, Tochigi, Japan

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Oyama, Tochigi, Japan

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Shimotsuke, Tochigi, Japan

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Yoshinogawa, Tokushima, Japan

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Chiyoda City, Tokyo, Japan

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Edogawa City, Tokyo, Japan

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Otaku, Tokyo, Japan

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Setagaya City, Tokyo, Japan

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Sumida City, Tokyo, Japan

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Takaoka, Toyama, Japan

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Tonami, Toyama, Japan

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Yonezawa, Yamagata, Japan

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Hōfu, Yamaguchi, Japan

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Fukuoka, Japan

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Gifu, Japan

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Hiroshima, Japan

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Kagashima, Japan

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Kagoshima, Japan

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Kochi, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Nagano, Japan

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Nagasaki, Japan

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Osaka, Japan

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Ōita, Japan

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Saitama, Japan

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Shizuoka, Japan

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Tokushima, Japan

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

T 614

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kota Nagai
• Organization: Eisai Co., Ltd.

+81-3-3817-5238

Study Officials

• Kota Nagai

  JAC PCU. EPCS, Eisai Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2009
• First Posted: August 26, 2009
• Study Start: July 31, 2009
• Primary Completion: September 30, 2011
• Study Completion: September 30, 2011
• Last Updated: December 17, 2021
• Results First Posted: June 19, 2015

Record last verified: 2015-11

Locations

JP (72)