Back to resultsA Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
CNTO 148
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Fully Human anti-TNFa monoclonal antibody, CNTO148, Golimumab
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
CNTO 148 50 mg
CNTO 148 100 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
ACR 20% response
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT00771251
First Posted
October 10, 2008
Last Updated
November 2, 2015
Sponsor
Janssen Pharmaceutical K.K.
Collaborators
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00771251
Brief Title
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
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.
Collaborators
Mitsubishi Tanabe Pharma Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis, Fully Human anti-TNFa monoclonal antibody, CNTO148, Golimumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
311 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CNTO 148 50 mg
Arm Type
Experimental
Arm Title
CNTO 148 100 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CNTO 148
Other Intervention Name(s)
Golimumab
Intervention Description
50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 116.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
ACR 20% response
Time Frame
Weel 14
Secondary Outcome Measure Information:
Title
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)
Time Frame
Week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K. Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
22984173
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.
Results Reference
result
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=427&filename=CR015343_CSR.pdf
Description
A Study of Golimumab (CNTO148) monotherapy in Patients with Active Rheumatoid Arthritis
Learn more about this trial
A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)
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