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

Janssen (J&J Innovative Medicine)

Status: Terminated

Conditions: Spondylitis, Ankylosing

Treatments: Drug: NSAIDs; Drug: DMARDs; Drug: Infliximab

Study type: Observational

Funder types: Industry

Identifiers

NCT02293681

CR104999

REMICADEAKS4006 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

76 participants in 2 patient groups

Cohort 1: Infliximab and/or NSAIDs and DMRADs

Description:

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.

Treatment:

Drug: NSAIDs

Drug: Infliximab

Drug: DMARDs

Cohort 2: NSAIDs and DMARDs

Description:

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

Treatment:

Drug: NSAIDs

Drug: DMARDs