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:  NCT00760669
Date of registration: 24/09/2008
Prospective Registration: No
Primary sponsor: Janssen Korea, Ltd., Korea
Public title: An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants
Scientific title: Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients
Date of first enrolment: May 2007
Target sample size: 1061
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00760669
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Korea, Republic of
Contacts
Name:     Janssen Korea, Ltd., Korea Clinical Trial
Address: 
Telephone:
Email:
Affiliation:  Janssen Korea, Ltd., Korea
Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants with ankylosing spondylitis who did not show adequate response to general
treatments and with increased serological indices related to severe axial symptoms and
inflammation

- Participants with rheumatoid arthritis who show insufficient response to disease
modifying antirheumatic drug (DMARD) including methotrexate

- Participants with serious, active and progressive disease not previously treated with
methotrexate or other DMARD

- Participant with moderate to serious plaque psoriasis who are unresponsive, contra
indicant or intolerable to the systemic therapy including cyclosporine, methotrexate
or Psoralen Ultra-Violet A (PUVA)

- Participant with active, progressive, psoriatic arthritis who have shown insufficient
response to DMARD treatment

Exclusion Criteria:



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Arthritis, Psoriatic
Arthritis, Rheumatoid
Psoriasis
Spondylitis, Ankylosing
Intervention(s)
Drug: Infliximab; observational study
Drug: Methotrexate; observational study
Primary Outcome(s)
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30 [Time Frame: Baseline and Week 30]
Change From Baseline in C-Reactive Protein (CRP) at Week 30 [Time Frame: Baseline and Week 30]
Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30 [Time Frame: Baseline and Week 30]
Change From Baseline in Number of Swollen Joints at Week 30 [Time Frame: Baseline and Week 30]
Change From Baseline in Number of Tender Joints at Week 30 [Time Frame: Baseline and Week 30]
Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30 [Time Frame: Baseline and Week 30]
Number of Participants With Adverse Drug Reactions [Time Frame: Baseline up to Week 30]
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to Week 30]
Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction [Time Frame: Baseline up to Week 30]
Number of Participants With Unexpected Adverse Events [Time Frame: Baseline up to Week 30]
Overall Efficacy Assessment [Time Frame: Baseline up to Week 30]
Secondary Outcome(s)
Secondary ID(s)
CR100768
REMICADEAKS4004
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 12/08/2013
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00760669
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