Status:
TERMINATED
An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Spondylitis, Ankylosing
Eligibility:
All Genders
16-40 years
Brief Summary
The purpose of this observational (a study that follows participants forward in time) study is to compare the functional improvement of hip joint using Harris hip score between 2 treatment groups (inf...
Detailed Description
This is a multi-center (when more than 1 hospital or medical school team work on a medical research study), observational study to compare the effectiveness of infliximab with conventional therapies i...
Eligibility Criteria
Inclusion
- Diagnosed with ankylosing spondylitis (AS) (according to the modified New York Criteria for AS) at least 3 months prior to the Day 1 in the Follow-up I phase with symptoms of active disease atScreening/Baseline
- Hip pain and duration of hip symptom less than 2 years
- Harris hip score less than (\<) 70
- Hip involvement proven by Magnetic resonance imaging (MRI)
- Being treated with infliximab and conventional therapy for 2 weeks to 6 months
Exclusion
- Participant has a history of hip joint disability which was considered irreversible
- Participant has a history of hip joint replacement
- Participant has a history of treatment with biologics other than infliximab less than 6 months prior to study entry
Key Trial Info
Start Date :
April 10 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2017
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT02293681
Start Date
April 10 2015
End Date
May 31 2017
Last Update
November 1 2017
Active Locations (6)
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1
Beijing, China
2
Changsha, China
3
Chengdu, China
4
Guangzhou, China