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

• Status: Terminated
• Trial end date: 2017-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Antirheumatic Agents; Aspirin; Ibuprofen; Infliximab; Naproxen; Sulfasalazine; Thalidomide

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