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An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement

NCT ID: NCT02293681

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-10

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Spondylitis, Ankylosing

Keywords

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Spondylitis, Ankylosing Infliximab Non-steroidal anti-inflammatory drugs Disease-modifying anti-rheumatic drugs

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Infliximab

Intervention Type DRUG

This is an observational study. Participants receiving intravenous infusion of infliximab will be observed.

NSAIDs

Intervention Type DRUG

This is an observational study. Participants receiving aspirin, ibuprofen and naproxen as NSAIDs will be observed.

DMARDs

Intervention Type DRUG

This is an observational study. Participants receiving methotrexate (MTX), sulfasalazine, and thalidomide as DMRADs will be observed.

Cohort 2: NSAIDs and DMARDs

Participants receiving NSAIDs (aspirin, ibuprofen and naproxen) and DMARDs (MTX, sulfasalazine, and thalidomide) will be observed.

NSAIDs

Intervention Type DRUG

This is an observational study. Participants receiving aspirin, ibuprofen and naproxen as NSAIDs will be observed.

DMARDs

Intervention Type DRUG

This is an observational study. Participants receiving methotrexate (MTX), sulfasalazine, and thalidomide as DMRADs will be observed.

Interventions

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Infliximab

This is an observational study. Participants receiving intravenous infusion of infliximab will be observed.

Intervention Type DRUG

NSAIDs

This is an observational study. Participants receiving aspirin, ibuprofen and naproxen as NSAIDs will be observed.

Intervention Type DRUG

DMARDs

This is an observational study. Participants receiving methotrexate (MTX), sulfasalazine, and thalidomide as DMRADs will be observed.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Beijing, , China

Site Status

Changsha, , China

Site Status

Chengdu, , China

Site Status

Guangzhou, , China

Site Status

Shanghai, , China

Site Status

Xi'an, , China

Site Status

Countries

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China

Other Identifiers

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REMICADEAKS4006

Identifier Type: OTHER

Identifier Source: secondary_id

CR104999

Identifier Type: -

Identifier Source: org_study_id