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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 18 April 2017
Main ID:  ChiCTR-TRC-10001060
Date of registration: 2010-10-23
Prospective Registration: No
Primary sponsor: People's Hospital, Beijing University; Shanghai Changzheng Hospital
Public title: Efficacy and safety of infliximab in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial
Scientific title: Efficacy and safety of infliximab in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial
Date of first enrolment: 2008-12-01
Target sample size: infliximab:0;placebo:0;
Recruitment status: Completed
URL:  http://www.chictr.org.cn/showproj.aspx?proj=8478
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  III (Phase III study)
Countries of recruitment
China
Contacts
Name: Fuji Xu   
Address:  415 Feng-yang Road, Shanghai, China 200003
Telephone: +86 21 81885511
Email: baojun@smmu.edu.cn
Affiliation: 
Name: Jun Bao   
Address:  415 Feng-yang Road, Shanghai, China 200003
Telephone: +86 21 81885513
Email: baojun@smmu.edu.cn
Affiliation:  Shanghai Changzheng Hospital
Key inclusion & exclusion criteria
Inclusion criteria: 1. Patients fulfilled the revised 1987 American Rheumatism Association criteria for the classification of RA;
2. Patients with active disease despite consecutive treatment with MTX at a stable dosage of 10-25 mg per week for at least 12 weeks before enrollment. Active RA was defines as four or more swollen joints, six or more tender joints and at least one of the following: a serum C reactive protein (CRP) level of at least 15 mg/l or an erythrocyte sedimentation rate (ESR) of at least 28 mm/hour, or morning stiffness lasting longer than 45 minutes;
3. Patients were allowed to take nonsteroidal antiinflammatory drugs or oral corticosteroids (<=10 mg/day of prednisone or equivalent) if the dose had been stable for at least 4 weeks prior to entry.

Exclusion criteria: 1. Patient were allergic to the drug;
2. Patients receiveded intraarticular corticosteroid injections and disease modifying antirheumatic drugs (except MTX) treatment 4 weeks before the study;
3. Patiients previously received any biologic therapy;
4. Patients had significant systemic disease or autoimmune disease other than RA, acute infections, history of type B or C hepatitis, tuberculosis and malignant tumor.


Age minimum: 18
Age maximum: 65
Gender: Both
Health Condition(s) or Problem(s) studied
M05.901
rheumatoid arthritis
Intervention(s)
infliximab:intravenous injections of infliximab (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy;placebo:intravenous injections of placebo (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy;
Primary Outcome(s)
Efficacy endpoint(ACR score);
Secondary Outcome(s)
Efficacy endpoint(DAS28);
Secondary ID(s)
Source(s) of Monetary Support
Shanghai CP Guojian Pharmaceutical Co., Ltd
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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