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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00760669 |
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Date of registration:
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24/09/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants
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Scientific title:
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Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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1061 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00760669 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Janssen Korea, Ltd., Korea Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Korea, Ltd., Korea |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Arthritis, Psoriatic
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Arthritis, Rheumatoid
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Psoriasis
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Spondylitis, Ankylosing
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Intervention(s)
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Drug: Methotrexate; observational study
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Drug: Infliximab; observational study
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Primary Outcome(s)
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Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction
[Time Frame: Baseline up to Week 30]
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Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30
[Time Frame: Baseline and Week 30]
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Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30
[Time Frame: Baseline and Week 30]
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Change From Baseline in C-Reactive Protein (CRP) at Week 30
[Time Frame: Baseline and Week 30]
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Change From Baseline in Number of Swollen Joints at Week 30
[Time Frame: Baseline and Week 30]
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
[Time Frame: Baseline up to Week 30]
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Number of Participants With Unexpected Adverse Events
[Time Frame: Baseline up to Week 30]
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Number of Participants With Adverse Drug Reactions
[Time Frame: Baseline up to Week 30]
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Overall Efficacy Assessment
[Time Frame: Baseline up to Week 30]
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Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30
[Time Frame: Baseline and Week 30]
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Change From Baseline in Number of Tender Joints at Week 30
[Time Frame: Baseline and Week 30]
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Secondary ID(s)
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CR100768
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REMICADEAKS4004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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