World Health Organization site
Skip Navigation Links

Main
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: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00896168
Date of registration: 07/05/2009
Prospective Registration: No
Primary sponsor: Xian-Janssen Pharmaceutical Ltd.
Public title: An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis
Scientific title: A Multi-Center, Pre-Marketing Clinical Trial to Evaluate the Efficacy and Safety of Infliximab Treatment on Rheumatoid Arthritis
Date of first enrolment: June 2007
Target sample size: 234
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00896168
Study type:  Interventional
Study design:   
Phase:  Phase 4
Countries of recruitment
Contacts
Name:     Xian-Janssen Pharmaceutical Ltd. Clinical Trial
Address: 
Telephone:
Email:
Affiliation:  Xian-Janssen Pharmaceutical Ltd.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants who have a definitive diagnosis of rheumatoid arthritis (RA) based on the
American College of Rheumatology Criteria 1987

- Participants must have been on Methotrexate (MTX) for 12 weeks at the stable dose for
at least 4 weeks

- Participants using oral corticosteroids, must have been on a stable dose of prednisone
less than 10 milligram per day (mg/day) or its equivalent for at least 4 weeks before
screening or if currently not using corticosteroids, the participant must not have
received corticosteroids for at least 4 weeks before screening

- Participants with moderate to severe RA (Disease Activity Score [DAS28] greater than
3.2)

- Male participants shall adopt contraceptive measures during the trial and within 6
months after the completion of trial (such as spermicidal barrier), or their female
sexual partners shall agree to adopt effective contraceptive measures during the trial
or within 6 months after the completion of trial (such as oral contraceptives,
contraceptives for injection, intrauterine device [IUD], or sterilization by surgery);
female participants of childbearing potential with negative urine pregnancy test upon
enrollment in addition to adopting the said contraceptive measures

Exclusion Criteria:

- Participant who has a known allergy to human immunoglobulin proteins or other
components of infliximab

- Participant who has a history of receiving infliximab or any other biological
preparations

- Participant who is in stage IV RA evaluated by X-ray

- Participants suffering from tuberculosis

- Female participant or male participant's wife who plans to become pregnant during this
study and within 6 months after completion of this study



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Arthritis, Rheumatoid
Intervention(s)
Drug: Infliximab
Drug: Methotrexate
Primary Outcome(s)
Percentage of Participants Achieving American College of Rheumatology Score 20 Percent (ACR20) Response [Time Frame: Week 26]
Percentage of Participants Achieving American College of Rheumatology Score 50 Percent (ACR50) Response [Time Frame: Week 26]
Percentage of Participants Achieving American College of Rheumatology Score 70 Percent (ACR70) Response [Time Frame: Week 26]
Secondary Outcome(s)
Change From Baseline in C-Reactive Protein (CRP) at Week 26 [Time Frame: Baseline and Week 26]
Change From Baseline in Duration of Morning Stiffness at Week 26 [Time Frame: Baseline and Week 26]
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 26 [Time Frame: Baseline and Week 26]
Change From Baseline in Health Assessment Questionnaire (HAQ) at Week 26 [Time Frame: Baseline and Week 26]
Change From Baseline in Participant's Pain Visual Analogue Scale (VAS) Score at Week 26 [Time Frame: Baseline and Week 26]
Change From Baseline in Participants' Global Disease Assessment at Week 26 [Time Frame: Baseline and Week 26]
Change From Baseline in Physicians' Global Disease Assessment at Week 26 [Time Frame: Baseline and Week 26]
Change From Baseline in Swollen Joints Count at Week 26 [Time Frame: Baseline and Week 26]
Change From Baseline in Tender Joints Count at Week 26 [Time Frame: Baseline and Week 26]
Secondary ID(s)
CR015460
REMICADEART4005
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 13/09/2013
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00896168
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history