Study 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.
Effectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (AS) (P06451)
HACER
Hip Arthritis Associated With AS Efficacy and Safety of Early Treatment With Infliximab (Remicade®)
2 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2010
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 21, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedApril 30, 2015
April 1, 2015
6 months
June 21, 2010
April 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with clinical improvement assessed by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire
Baseline and Week 15
Study Arms (1)
Remicade
EXPERIMENTALInfliximab 5 mg/kg was administered as specified in the Summary of Product Characteristics for patients with ankylosing spondylitis
Interventions
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
Eligibility Criteria
You may qualify if:
- 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®)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2010
First Posted
June 22, 2010
Study Start
June 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
April 30, 2015
Record last verified: 2015-04