Clinical trial NCT00727987: A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Official title: A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Fully Human anti-TNFa monoclonal antibody
CNTO148
Golimumab
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
Collaborators: name: Mitsubishi Tanabe Pharma Corporation
First posted: 2008-08-05
Enrollment: 269
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This clinical study is scheduled to be performed for the purpose of evaluating the safety and effectiveness of golimumab (CNTO148) administered in combination with stable dose (6-8mg/week) of methotrexate (MTX) to patients with rheumatoid arthritis (RA). CNTO148 50 mg group: CNTO148 50 mg SC injections every 4 weeks from the first administration until week 152. If early escape, 100 mg SC injections every 4 weeks from week 16 until week 152. CNTO148 100 mg group: CNTO148 100 mg SC injections every 4 weeks from the first administration until week 152 whether early escape or not Placebo group: Placebo SC injections every 4 weeks from the first administration until week 20 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 152

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: ACR 20% response
timeFrame: Week 14
Secondary outcomes:
measure: 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)
timeFrame: Week 14
Other outcomes:
Locations:
city: Asahikawa
country: Japan
city: Asahi
country: Japan
city: Azumino
country: Japan
city: Chiba
country: Japan
city: Fukui
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Gifu
country: Japan
city: Goshogawara
country: Japan
city: Hachioji
country: Japan
city: Hamamatsu
country: Japan
city: Higashi-Hiroshima
country: Japan
city: Hiki
country: Japan
city: Hiroshima
country: Japan
city: Hitachi
country: Japan
city: Iruma
country: Japan
city: Izumisano
country: Japan
city: Izumo
country: Japan
city: Kamakura
country: Japan
city: Kato
country: Japan
city: Kawachi-Nagano
country: Japan
city: Kawagoe
country: Japan
city: Kawasaki
country: Japan
city: Kita-Gun
country: Japan
city: Kitakyushu
country: Japan
city: Kitamoto
country: Japan
city: Kobe
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Matsue
country: Japan
city: Matsumoto
country: Japan
city: Matsuyama
country: Japan
city: Nagano
country: Japan
city: Nagasaki
country: Japan
city: Nagoya
country: Japan
city: Narashino
country: Japan
city: Nishinomiya
country: Japan
city: Ohta-Ku
country: Japan
city: Oita
country: Japan
city: Osaka-City
country: Japan
city: Osaka
country: Japan
city: Osaki
country: Japan
city: Sagamihara
country: Japan
city: Saitama
country: Japan
city: Sapporo
country: Japan
city: Sasebo
country: Japan
city: Sendai N/A
country: Japan
city: Sendai
country: Japan
city: Shimotsuga
country: Japan
city: Shimotsuke
country: Japan
city: Shinjuku-Ku
country: Japan
city: Shinjuku
country: Japan
city: Shizuoka
country: Japan
city: Suita
country: Japan
city: Tokorozawa
country: Japan
city: Tokushima N/A
country: Japan
city: Tokyo N/A
country: Japan
city: Tokyo
country: Japan
city: Toshima-Ku
country: Japan
city: Toyama
country: Japan
city: Toyoake
country: Japan
city: Toyohashi
country: Japan
city: Tsukuba
country: Japan
city: Tsukubo
country: Japan
city: Tsu
country: Japan
city: Ube
country: Japan
city: Yokohama N/A
country: Japan
city: Yokohama
country: Japan
city: Yufu
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.