A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis
2 other identifiers
interventional
269
1 country
65
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 rheumatoid-arthritis
Started May 2008
Typical duration for phase_3 rheumatoid-arthritis
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 31, 2008
CompletedFirst Posted
Study publicly available on registry
August 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMay 23, 2013
May 1, 2013
3.6 years
July 31, 2008
May 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ACR 20% response
Week 14
Secondary Outcomes (1)
ACR 50% response, ACR 70% response, ACR 90% response, Changes from the pretreatment values in the DAS (Disease Activity Score) 28, and the HAQ (Health assessment questionnaire)
Week 14
Study Arms (3)
CNTO 148 50 mg + methotrexate
EXPERIMENTALCNTO 148 100 mg + methotrexate
EXPERIMENTALPlacebo + methotrexate
PLACEBO COMPARATORInterventions
50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 152.
Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 24.
6 mg/week to 8 mg/week taken orally (by mouth) from at least 4 weeks before the initial investigational treatment to the completion of assessment at Week 52.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with rheumatoid arthritis at least 3 months prior to registration and who are definitely identified as having rheumatoid arthritis, at the time of informed consent, according to the criteria for classification established by the American College of Rheumatology (1987)
- Patients in whom MTX therapy (\>= 6 mg/week) was started more than 3 months before the first administration and who have been treated with MTX at a stable dose (6-8 mg/week) for at least 4 weeks before the first administration
- Patients having at least 4 swollen joints and at least 4 tender joints at the time of registration and immediately before the first administration.
You may not qualify if:
- Patients with a history of hypersensitivity to human immunoglobulin proteins or other ingredients of golimumab
- Patients who have previously experienced or are suffering from any of the following diseases: (i) Collagen diseases other than rheumatoid arthritis, (ii) Latent or active granulomatous infections such as histoplasmosis and coccidioidomycosis, (iii) Felty syndrome, etc
- Patients with a severe, advanced, or poorly controlled disease in any of the kidney, liver, blood, gastrointestinal system, endocrine system, lung, heart, nervous system, psychiatric system, and brain.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Pharmaceutical K.K.lead
- Tanabe Pharma Corporationcollaborator
Study Sites (65)
Unknown Facility
Asahi, Japan
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Asahikawa, Japan
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Azumino, Japan
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Chiba, Japan
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Fukui, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gifu, Japan
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Goshogawara, Japan
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Hachiōji, Japan
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Hamamatsu, Japan
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Higashi-Hiroshima, Japan
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Hiki, Japan
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Hiroshima, Japan
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Hitachi, Japan
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Iruma, Japan
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Izumisano, Japan
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Izumo, Japan
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Kamakura, Japan
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Katō, Japan
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Kawachi-Nagano, Japan
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Kawagoe, Japan
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Kawasaki, Japan
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Kita-Gun, Japan
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Kitakyushu, Japan
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Kitamoto, Japan
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Kobe, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Matsue, Japan
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Matsumoto, Japan
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Matsuyama, Japan
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Nagano, Japan
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Nagasaki, Japan
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Nagoya, Japan
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Narashino, Japan
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Nishinomiya, Japan
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Ohta-Ku, Japan
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Osaka, Japan
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Ōita, Japan
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Ōsaki, Japan
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Sagamihara, Japan
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Saitama, Japan
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Sapporo, Japan
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Sasebo, Japan
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Sendai, Japan
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Shimotsuga, Japan
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Shimotsuke, Japan
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Shinjuku, Japan
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Shinjuku-Ku, Japan
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Shizuoka, Japan
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Suita, Japan
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Tokorozawa, Japan
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Tokushima, Japan
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Tokyo, Japan
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Toshima-Ku, Japan
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Toyama, Japan
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Toyoake, Japan
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Toyohashi, Japan
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Tsu, Japan
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Tsukuba, Japan
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Tsukubo, Japan
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Ube, Japan
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Yokohama, Japan
Unknown Facility
Yufu, Japan
Related Publications (1)
Tanaka Y, Harigai M, Takeuchi T, Yamanaka H, Ishiguro N, Yamamoto K, Miyasaka N, Koike T, Kanazawa M, Oba T, Yoshinari T, Baker D; GO-FORTH Study Group. Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: results of the GO-FORTH study. Ann Rheum Dis. 2012 Jun;71(6):817-24. doi: 10.1136/ard.2011.200317. Epub 2011 Nov 25.
PMID: 22121129DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2008
First Posted
August 5, 2008
Study Start
May 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
May 23, 2013
Record last verified: 2013-05