Back to resultsEffectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (AS) (P06451) (HACER)
Primary Purpose
Ankylosing Spondylitis
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Infliximab
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Ankylosing spondylitis, Hip arthritis, Infliximab
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Remicade
Arm Description
Infliximab 5 mg/kg was administered as specified in the Summary of Product Characteristics for patients with ankylosing spondylitis
Outcomes
Primary Outcome Measures
Number of participants with clinical improvement assessed by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT01148901
First Posted
June 21, 2010
Last Updated
April 29, 2015
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Hospital Universitario Reina Sofia de Cordoba, Dr. Jose María Martos Becerra (Central Radiological Assessment) - Hospital de Alta Resolución, Puente Genil (Spain)
1. Study Identification
Unique Protocol Identification Number
NCT01148901
Brief Title
Effectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (AS) (P06451)
Acronym
HACER
Official Title
Hip Arthritis Associated With AS Efficacy and Safety of Early Treatment With Infliximab (Remicade®)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
No patient enrolled after 6 months from the start. The decision to withdraw the study was based on a feasibility reevaluation conducted with investigators.
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Hospital Universitario Reina Sofia de Cordoba, Dr. Jose María Martos Becerra (Central Radiological Assessment) - Hospital de Alta Resolución, Puente Genil (Spain)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Ankylosing spondylitis, Hip arthritis, Infliximab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remicade
Arm Type
Experimental
Arm Description
Infliximab 5 mg/kg was administered as specified in the Summary of Product Characteristics for patients with ankylosing spondylitis
Intervention Type
Drug
Intervention Name(s)
Infliximab
Other Intervention Name(s)
Remicade, SCH 215596
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants with clinical improvement assessed by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire
Time Frame
Baseline and Week 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (AS) (P06451)
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