Status:
COMPLETED
Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis
Lead Sponsor:
Association de Recherche Clinique en Rhumatologie
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Continuous treatment with the anti-tumor necrosis factor alpha monoclonal antibody infliximab is efficacious in ankylosing spondylitis (AS), whereas treatment discontinuation results in disease relaps...
Detailed Description
Patients with active AS were randomly assigned to receive infliximab every 6 weeks (Q6), or only upon symptoms recurrence (on-demand), following a loading regimen of infusions at weeks 0, 2, and 6. Pa...
Eligibility Criteria
Inclusion
- Adult patients (\> 18 years old)
- With a diagnosis of AS
- With at least one of the following evidences for active inflammation, present within 3 months before inclusion: a serum C-reactive protein (CRP) level above twice the upper limit value of the normal range, a positive magnetic resonance imaging of the spine or sacro-iliac joints, a vascularized enthesitis by power-Doppler ultrasound technic.
- Presence of clinically active axial disease, as defined by 1) a Bath AS Disease Activity Index (BASDAI) (18) of ≥ 3/10, and 2) a score of ≥ 3/10 for axial pain (second item of BASDAI).
- Disease-modifying antirheumatic drugs (DMARDs), such as sulphasalazine, methotrexate, hydroxychloroquine, intra-muscular gold, thiol compound, cyclosporin, intravenous biphosphonate had to be discontinued for at least 4 weeks before inclusion.
- Dosages of NSAIDs and corticosteroid were required to remain stable for at least 4 weeks before inclusion.
- A negative pregnancy test result was required for non menopausal female patients, and contraception during the study period and for six months after the last infusion of infliximab was recommended to all patients of childbearing potential.
Exclusion
- Pregnancy.
- Breastfeeding.
- Vaccination with a live organism during the last month.
- Present infection or any episode of serious infection within the last three months.
- Active malignancy within the previous five years.
- Alcohol or drug addiction.
- Severe chronic concomitant disease.
- Administration of an investigational drug within the last three months, or of any known TNF inhibitor therapy in the past (such as thalidomide, infliximab or etanercept).
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00439283
Start Date
April 1 2003
End Date
December 1 2004
Last Update
February 27 2007
Active Locations (31)
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1
CHU Amiens
Amiens, France, 80054
2
CHU Hôpital Minjoz
Besançon, France, 25030
3
Hôpital Avicenne
Bobigny, France, 93009
4
Hôpital Pellegrin
Bordeaux, France, 33076