Study Stopped
The project was stopped by 31-May-2017 because of internal owner decision from out of balance enrollment from two groups.
An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement
RECOVERY
A Multicenter and Observational Study to Assess the Effectiveness of Infliximab Comparing With Conventional Therapy in Ankylosing Spondylitis Subjects With Hip Involvement
2 other identifiers
observational
76
1 country
6
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 (infliximab and conventional therapy) at Week 30 in ankylosing spondylitis (an autoimmune disease causing chronic inflammation at tendon ends and ligament attachment points) participants with hip involvement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2015
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2014
CompletedFirst Posted
Study publicly available on registry
November 18, 2014
CompletedStudy Start
First participant enrolled
April 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedNovember 1, 2017
October 1, 2017
2.1 years
November 14, 2014
October 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Harris Hip Score at Week 30
Harris hip score, a physician-assessed scoring method consisting of 10 items: pain, limp, support, distance walked, sitting, enter public transportation, stairs, put on shoes and socks, absence of deformity and range of motion. The scoring system covers domains like pain, function, absence of deformity and range of motion. The total Harris hip score has a maximum of 100 points with a higher score indicating a better hip function: Excellent (90-100), Good (80-89), Fair (70-79) and Poor (\<70).
Baseline and Week 30
Secondary Outcomes (6)
Change From Baseline in Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Score at Week 30 and 52
Baseline, Week 30 and 52
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 30 and 52
Baseline, Week 30 and 52
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score at Week 30 and 52
Baseline, Week 30 and 52
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 30 and 52
Baseline, Week 30 and 52
Change From Baseline in Harris Hip Score at Week 14 and 52
Baseline, Week 14 and 52
- +1 more secondary outcomes
Study Arms (2)
Cohort 1: Infliximab and/or NSAIDs and DMRADs
Participants receiving intravenous infusion of infliximab with or without non-steroidal anti-inflammatory drugs (NSAIDs: aspirin, ibuprofen and naproxen) and Disease-modifying anti-rheumatic drugs (DMRADs: methotrexate (MTX), sulfasalazine, and thalidomide) will be observed.
Cohort 2: NSAIDs and DMARDs
Participants receiving NSAIDs (aspirin, ibuprofen and naproxen) and DMARDs (MTX, sulfasalazine, and thalidomide) will be observed.
Interventions
This is an observational study. Participants receiving intravenous infusion of infliximab will be observed.
This is an observational study. Participants receiving aspirin, ibuprofen and naproxen as NSAIDs will be observed.
This is an observational study. Participants receiving methotrexate (MTX), sulfasalazine, and thalidomide as DMRADs will be observed.
Eligibility Criteria
Participants suffering from ankylosing spondylitis with hip involvement.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Beijing, China
Unknown Facility
Changsha, China
Unknown Facility
Chengdu, China
Unknown Facility
Guangzhou, China
Unknown Facility
Shanghai, China
Unknown Facility
Xi'an, China
Biospecimen
Blood samples will be retained for the assessment of laboratory parameters: CRP = C-reactive protein; ESR = erythrocyte sedimentation rate.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 52 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2014
First Posted
November 18, 2014
Study Start
April 10, 2015
Primary Completion
May 31, 2017
Study Completion
May 31, 2017
Last Updated
November 1, 2017
Record last verified: 2017-10