Clinical trial NCT02293681: An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement
Official title: A Multicenter and Observational Study to Assess the Effectiveness of Infliximab Comparing With Conventional Therapy in Ankylosing Spondylitis Subjects With Hip Involvement
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spondylitis, Ankylosing
Keywords: Spondylitis, Ankylosing
Infliximab
Non-steroidal anti-inflammatory drugs
Disease-modifying anti-rheumatic drugs
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-11-18
Enrollment: 76
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants suffering from ankylosing spondylitis with hip involvement.

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.

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 in ankylosing spondylitis participants with hip joint involvement. The study will be conducted in 3 parts: a 14-day screening, a 30-week first follow-up (Follow-up 1), and an additional 22-week follow-up (Follow-up 2) up to Week 52. Participants will be assigned to two groups based on the current treatments they are receiving: cohort 1 participants receiving infliximab with or without combination of disease modifying drugs (DMARDs-such as Sulfasalazine, Methotrexate and Thalidomide) and/or non-steroidal anti-inflammatory drugs (NSAIDs) and in cohort 2 who are receiving DMARDs and/or NSAIDs for treatment of pain will be observed. Participants will primarily be assessed for change in harris hip score. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Harris Hip Score at Week 30
timeFrame: Baseline and Week 30
Secondary outcomes:
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Score at Week 30 and 52
timeFrame: Baseline, Week 30 and 52
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 30 and 52
timeFrame: Baseline, Week 30 and 52
measure: Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score at Week 30 and 52
timeFrame: Baseline, Week 30 and 52
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 30 and 52
timeFrame: Baseline, Week 30 and 52
measure: Change From Baseline in Harris Hip Score at Week 14 and 52
timeFrame: Baseline, Week 14 and 52
measure: Assessment of Improvement in Hip Joint
timeFrame: Baseline, Week 30 and 52
Other outcomes:
Locations:
city: Beijing
country: China
city: Changsha
country: China
city: Chengdu
country: China
city: Guangzhou
country: China
city: Shanghai
country: China
city: Xi'An
country: China
city: Xian
country: China
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: