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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02293681
• Date of registration: 14/11/2014
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement RECOVERY
• Scientific title: A Multicenter and Observational Study to Assess the Effectiveness of Infliximab Comparing With Conventional Therapy in Ankylosing Spondylitis Subjects With Hip Involvement
• Date of first enrolment: April 10, 2015
• Target sample size: 76
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02293681
• Study type: Observational [Patient Registry]
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Spondylitis, Ankylosing

Intervention(s)

Drug: DMARDs

Drug: NSAIDs

Drug: Infliximab

Primary Outcome(s)

Change From Baseline in Harris Hip Score at Week 30 [Time Frame: Baseline and Week 30]

Secondary Outcome(s)

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 30 and 52 [Time Frame: Baseline, Week 30 and 52]

Change From Baseline in Harris Hip Score at Week 14 and 52 [Time Frame: Baseline, Week 14 and 52]

Assessment of Improvement in Hip Joint [Time Frame: Baseline, Week 30 and 52]

Change From Baseline in Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Score at Week 30 and 52 [Time Frame: Baseline, Week 30 and 52]

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 30 and 52 [Time Frame: Baseline, Week 30 and 52]

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score at Week 30 and 52 [Time Frame: Baseline, Week 30 and 52]

Secondary ID(s)

CR104999

REMICADEAKS4006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors