Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis
Continuous treatment with the anti-tumor necrosis factor alpha monoclonal antibody infliximab is efficacious in ankylosing spondylitis (AS), whereas treatment discontinuation results in disease relapse, with variable delay. Objective of this study was to compare efficacy between a continuous treatment with infliximab, and a treatment adapted to symptoms recurrence. Addition of methotrexate (MTX)to infliximab was also tested.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis: Comparison of Infusion Every 6 Weeks Versus Infusion on Demand|
- The primary end point was the proportion of patients with a 20% improvement response according to the ASAS criteria, at week 54.
- Achievement of the ASAS50 and ASAS70.
- The proportion of patients who experienced a partial remission, according to ASAS definition.
- Improvement in independent components of the ASAS response criteria.
- Schober test.
- Finger to floor test.
- Chest expansion score.
- Occiput-to-wall measurements.
- Acute-phase reactants (erythrocyte sedimentation rate and C-reactive protein level).
- Number of infusions administered after the loading regimen.
- Number of patients requiring an increase in the dose of infliximab.
- The area under the curves (AUCs) of the BASDAI recorded on a weekly basis on automatic phone server, calculated from week 0 through week 54.
- The area under the curves (AUCs) of the global pain scores recorded on a weekly basis on automatic phone server, calculated from week 0 through week 54.
|Study Start Date:||April 2003|
|Estimated Study Completion Date:||December 2004|
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. Patients in the latter group were randomly assigned to receive MTX or not, starting 4 weeks prior to infliximab. Monitoring was performed over one year. The primary end point was the proportion of patients with a 20% improvement response according to the ASsessment in Ankylosing Spondylitis (ASAS) criteria, at week 54.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439283
|Amiens, France, 80054|
|CHU Hôpital Minjoz|
|Besançon, France, 25030|
|Bobigny, France, 93009|
|Bordeaux, France, 33076|
|Hôpital Ambroise Paré|
|Boulogne Billancourt, France, 92104|
|CHU de la Cavale Blanche|
|Brest, France, 29609|
|CHU Côte de Nacre|
|Caen, France, 14033|
|Hôpital Gilles de Corbeil|
|Corbeil Essonnes, France, 91106|
|Hôpital Henri Mondor|
|Creteil, France, 94010|
|Dijon, France, 21000|
|CHU A. Michallon|
|Grenoble, France, 38043|
|Groupe Hospitalier du Havre|
|Le Havre, France, 76083|
|Le Kremlin Bicêtre, France, 94275|
|CHRU Hôpital Roger Salengro|
|Lille, France, 59037|
|Limoges, France, 87042|
|Centre Hospitalier Saint Philibert|
|Lomme, France, 59160|
|CH St Joseph - St Luc|
|Lyon, France, 69365|
|Hôpital de la Conception|
|Marseille, France, 13385|
|Montpellier, France, 34295|
|CHU l'Archet 1|
|Nice, France, 06202|
|Hôpital Porte Madeleine|
|Orléans, France, 45032|
|Paris, France, 75014|
|Hôpital de la Pitié|
|Paris, France, 75013|
|CHU de Poitiers|
|Poitiers, France, 86021|
|CHU - Hôpital Sud|
|Rennes, France, 35056|
|CHU - Hôpital de Bois Guillaume|
|Rouen, France, 76031|
|Saint-Etienne, France, 42055|
|Strasbourg, France, 67098|
|Hôpital de Purpan|
|Toulouse, France, 31059|
|CHU Hôpital Trousseau|
|Tours, France, 37044|
|Vandoeuvre Les Nancy, France, 54511|
|Study Director:||Maxime DOUGADOS, Professor||ARCR|