A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)
NCT ID: NCT00771251
Last Updated: 2015-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
311 participants
INTERVENTIONAL
2008-05-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CNTO 148 50 mg
CNTO 148
50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 116.
CNTO 148 100 mg
CNTO 148
50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 116.
Placebo
Placebo
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.
Interventions
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CNTO 148
50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 116.
Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
20 Years
74 Years
ALL
No
Sponsors
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Mitsubishi Tanabe Pharma Corporation
INDUSTRY
Janssen Pharmaceutical K.K.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Pharmaceutical K.K. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Pharmaceutical K.K.
Locations
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Asahikawa, , Japan
Ayauta, , Japan
Azumino, , Japan
Chiba, , Japan
Fuchū, , Japan
Fukui, , Japan
Fukuoka, , Japan
Fukushima, , Japan
Gifu, , Japan
Goshogawara, , Japan
Hachiōji, , Japan
Hamamatsu, , Japan
Higashi-Hiroshima, , Japan
Hiki, , Japan
Hiroshima, , Japan
Hitachi, , Japan
Hitachi-Naka, , Japan
Iruma, , Japan
Izumisano, , Japan
Izumo, , Japan
Kamakura, , Japan
Katō, , Japan
Kawachi-Nagano, , Japan
Kawagoe, , Japan
Kawasaki, , Japan
Kita-Gun, , Japan
Kitakyushu, , Japan
Kitamoto, , Japan
Kobe, , Japan
Kumamoto, , Japan
Kyoto, , Japan
Matsue, , Japan
Matsumoto, , Japan
Matsuyama, , Japan
Nagano, , Japan
Nagoya, , Japan
Narashino, , Japan
Niigata, , Japan
Nishinomiya, , Japan
Ohta-Ku, , Japan
Osaka, , Japan
Ōita, , Japan
Ōsaka-sayama, , Japan
Ōsaki, , Japan
Sagamihara, , Japan
Saitama, , Japan
Sapporo, , Japan
Sasebo, , Japan
Sendai, , Japan
Shimotsuga, , Japan
Shimotsuke, , Japan
Shinjuku-Ku, , Japan
Shizuoka, , Japan
Suita, , Japan
Tokushima, , Japan
Tokyo, , Japan
Tomigusuku, , Japan
Toshima-Ku, , Japan
Toyama, , Japan
Toyoake, , Japan
Toyohashi, , Japan
Tsu, , Japan
Tsukuba, , Japan
Tsukubo, , Japan
Ube, , Japan
Yokohama, , Japan
Yufu, , Japan
Countries
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References
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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.
Related Links
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A Study of Golimumab (CNTO148) monotherapy in Patients with Active Rheumatoid Arthritis
Other Identifiers
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JNS012-JPN-04
Identifier Type: OTHER
Identifier Source: secondary_id
CR015343
Identifier Type: -
Identifier Source: org_study_id
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