Clinical trial NCT00771251: A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)
Official title: A Study of Golimumab (CNTO148) Monotherapy 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: 2008-10-13
Enrollment: 311
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 DMARD (Disease-modifying antirheumatic drugs) therapy. Another objective is to evaluate the pharmacokinetics of golimumab.

Detailed description: This study is designed as a placebo-controlled study of golimumab monotherapy for the purpose of demonstrating the safety and effectiveness of golimumab, a new, fully human anti-TNF (Tumor necrosis factor) a monoclonal antibody produced by mean of HuMab mouse technology. Other reasons for using the study design are as follows: the effects of golimumab given alone must be confirmed as in the case of other drugs; and golimumab may be used even in patients not on the treatment with methotrexate (MTX). There will be 3 treatment groups in the study as follows: CNTO148 50 mg group, CNTO 148 100 mg group, and Placebo group.

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 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 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: Weel 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: Ayauta
country: Japan
city: Azumino
country: Japan
city: Chiba
country: Japan
city: Fuchu
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: Hitachinaka
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: Nagoya
country: Japan
city: Narashino
country: Japan
city: Niigata
country: Japan
city: Nishinomiya
country: Japan
city: Ohta-Ku
country: Japan
city: Oita
country: Japan
city: Osaka-Sayama
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: Shizuoka
country: Japan
city: Suita
country: Japan
city: Tokushima
country: Japan
city: Tokyo N/A
country: Japan
city: Tokyo
country: Japan
city: Tomigusuku
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: 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.