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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 February 2015 |
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Main ID: |
NCT01220518 |
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Date of registration:
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04/10/2010 |
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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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Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS)
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Scientific title:
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Randomized, Double-blind, Parallel-group, Phase 1 Study |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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257 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01220518 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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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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Won Park, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Inha University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- diagnosed with active ankylosing spondylitis
- BASDAI score = 4 and visual analogue scale(VAS) score of spinal pain = 4
Exclusion Criteria:
- have total ankylosing of spine
- have allergies to infliximab
- serious infection
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: Infliximab
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Primary Outcome(s)
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PK equivalence to remicade
[Time Frame: PK sampling at week 22]
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Secondary Outcome(s)
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Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 14, 30 and 54 compared with Baseline
[Time Frame: at week 14, 30 and 54]
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Chest expansion at Weeks 14, 30 and 54 compared with Baseline
[Time Frame: at weeks 14, 30 and 54]
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Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline
[Time Frame: at week 14, 30 and 54]
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Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 20% criteria
[Time Frame: at week 14, 30 and 54]
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Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 30 and 54 compared with Baseline
[Time Frame: at weeks 14, 30 and 54]
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Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 40 criteria
[Time Frame: at week 14, 30 and 54]
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Quality of life questionnaire (SF-36)
[Time Frame: at week 14, 30 and 54]
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Secondary ID(s)
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CT-P13 1.1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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