Effectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (AS) (P06451)

Ankylosing Spondylitis Clinical Trial

— HACER  

Official title:

Hip Arthritis Associated With AS Efficacy and Safety of Early Treatment With Infliximab (Remicade®)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01148901
• Other study ID #: P06451
• Secondary ID: 2009-016587-36
• Status: Withdrawn
• Phase: Phase 4
• First received: June 21, 2010
• Last updated: April 29, 2015
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
• Study type: Interventional

Clinical Trial Summary

This trial is designed to measure improvement of hip involvement in patients with ankylosing spondylitis (AS) after receiving 4 doses of infliximab. Participants will receive infliximab 5 mg/kg (as an intravenous perfusion over a period of 2 hours) at Weeks 0, 2, 6, and 14, consistent with the approved dosing regimen described in the label. Participants will be evaluated for hip pain, functional capacity and stiffness before and after 14 weeks (4 doses) of treatment. Further treatment after 4 doses is based on standard clinical practice as determined by the trial site.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Ankylosing spondylitis (AS) diagnosis

• Have all 3 of the following:

• Presence of hip pain (nocturnal inflammatory pain)

• Limitation of hip mobility

• Patient's Global Assessment Visual Analog Scale (0-10 cm) =4 cm.

• Inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs)

• Eligible to be treated with Infliximab (Remicade®)

Exclusion Criteria:

• Causes of coaxalgia other than coxitis of AS, demonstrated by images or laboratory tests

• Women who are pregnant or nursing or plan to nurse or become pregnant

• Serious infections like sepsis, abscesses.

• History of or current certain infections

• History of or current certain medical conditions

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Infliximab
Infliximab 5 mg/kg administered as an intravenous perfusion over a period of 2 hours at Weeks 0, 2, 6, and 14, as indicated in the Summary of Product Characteristics

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Dr. Jose María Martos Becerra (Central Radiological Assessment) – Hospital de Alta Resolución, Puente Genil (Spain), Hospital Universitario Reina Sofia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with clinical improvement assessed by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire		Baseline and Week 15	No