NCT02293681

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

A Multicenter and Observational Study to Assess the Effectiveness of Infliximab Comparing With Conventional Therapy in Ankylosing Spondylitis Subjects With Hip Involvement

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 16 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spondylitis, Ankylosing

Interventions

Type	Name	Description
DRUG	Infliximab	This is an observational study. Participants receiving intravenous infusion of infliximab will be observed.
DRUG	NSAIDs	This is an observational study. Participants receiving aspirin, ibuprofen and naproxen as NSAIDs will be observed.
DRUG	DMARDs	This is an observational study. Participants receiving methotrexate (MTX), sulfasalazine, and thalidomide as DMRADs will be observed.

Timeline

• Start date: 2015-04-10
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2014-11-18
• Last updated: 2017-11-01

Locations

6 sites across 1 country: China