A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)
A Study of Golimumab (CNTO148) Monotherapy in Patients With Active Rheumatoid Arthritis
2 other identifiers
interventional
311
1 country
67
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite DMARD (Disease-modifying antirheumatic drugs) 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 P50-P75 for phase_3 rheumatoid-arthritis
Started May 2008
Typical duration for phase_3 rheumatoid-arthritis
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 10, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedNovember 3, 2015
November 1, 2015
3.4 years
October 10, 2008
November 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ACR 20% response
Weel 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
EXPERIMENTALCNTO 148 100 mg
EXPERIMENTALPlacebo
EXPERIMENTALInterventions
50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 116.
Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks until week 12 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 116.
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 who have previously not responded to at least one DMARD (before informed consent is obtained)
- Patients who, if they are on the treatment with a DMARD, the DMARD can be washed out for at least 4 weeks before the first administration
- Patients having at least 6 swollen joints and 6 tender joints at the time of registration and immediately before the first injection
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 (67)
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Asahikawa, Japan
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Ayauta, Japan
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Azumino, Japan
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Chiba, Japan
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Fuchū, 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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Hitachi-Naka, 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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Nagoya, Japan
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Narashino, Japan
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Niigata, 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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Ōsaka-sayama, 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-Ku, Japan
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Shizuoka, Japan
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Suita, Japan
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Tokushima, Japan
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Tokyo, Japan
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Tomigusuku, 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)
Takeuchi T, Harigai M, Tanaka Y, Yamanaka H, Ishiguro N, Yamamoto K, Miyasaka N, Koike T, Kanazawa M, Oba T, Yoshinari T, Baker D; GO-MONO study group. Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs: results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks. Ann Rheum Dis. 2013 Sep 1;72(9):1488-95. doi: 10.1136/annrheumdis-2012-201796. Epub 2012 Sep 14.
PMID: 22984173RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition 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
October 10, 2008
First Posted
October 13, 2008
Study Start
May 1, 2008
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
November 3, 2015
Record last verified: 2015-11