Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis
1 other identifier
interventional
240
1 country
31
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2003
31 active sites
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
April 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 22, 2007
CompletedFirst Posted
Study publicly available on registry
February 23, 2007
CompletedFebruary 27, 2007
February 1, 2007
February 22, 2007
February 26, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary end point was the proportion of patients with a 20% improvement response according to the ASAS criteria, at week 54.
Secondary Outcomes (14)
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.
BASDAI.
SF-36.
- +9 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients (\> 18 years old)
- With a diagnosis of AS
- 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).
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
CHU Amiens
Amiens, 80054, France
CHU Hôpital Minjoz
Besançon, 25030, France
Hôpital Avicenne
Bobigny, 93009, France
Hôpital Pellegrin
Bordeaux, 33076, France
Hôpital Ambroise Paré
Boulogne-Billancourt, 92104, France
CHU de la Cavale Blanche
Brest, 29609, France
CHU Côte de Nacre
Caen, 14033, France
Hôpital Gilles de Corbeil
Corbeil-Essonnes, 91106, France
Hôpital Henri Mondor
Créteil, 94010, France
Hôpital Général
Dijon, 21000, France
CHU A. Michallon
Grenoble, 38043, France
Groupe Hospitalier du Havre
Le Havre, 76083, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275, France
CHRU Hôpital Roger Salengro
Lille, 59037, France
CHU Dupuytren
Limoges, 87042, France
Centre Hospitalier Saint Philibert
Lomme, 59160, France
CH St Joseph - St Luc
Lyon, 69365, France
Hôpital de la Conception
Marseille, 13385, France
Hôpital Lapeyronie
Montpellier, 34295, France
CHU l'Archet 1
Nice, 06202, France
Hôpital Porte Madeleine
Orléans, 45032, France
Hôpital de la Pitié
Paris, 75013, France
Hôpital Cochin
Paris, 75014, France
CHU de Poitiers
Poitiers, 86021, France
CHU - Hôpital Sud
Rennes, 35056, France
CHU - Hôpital de Bois Guillaume
Rouen, 76031, France
CHU Saint-Etienne
Saint-Etienne, 42055, France
CHU Hautepierre
Strasbourg, 67098, France
Hôpital de Purpan
Toulouse, 31059, France
CHU Hôpital Trousseau
Tours, 37044, France
CHU Nancy-Brabois
Vandœuvre-lès-Nancy, 54511, France
Related Publications (2)
Fautrel B, Benhamou M, Breban M, Roy C, Lenoir C, Trape G, Baleydier A, Ravaud P, Dougados M. Cost effectiveness of two therapeutic regimens of infliximab in ankylosing spondylitis: economic evaluation within a randomised controlled trial. Ann Rheum Dis. 2010 Feb;69(2):424-7. doi: 10.1136/ard.2008.103887. Epub 2009 Sep 9.
PMID: 19740900DERIVEDBreban M, Ravaud P, Claudepierre P, Baron G, Henry YD, Hudry C, Euller-Ziegler L, Pham T, Solau-Gervais E, Chary-Valckenaere I, Marcelli C, Perdriger A, Le Loet X, Wendling D, Fautrel B, Fournie B, Combe B, Gaudin P, Jousse S, Mariette X, Baleydier A, Trape G, Dougados M; French Ankylosing Spondylitis Infliximab Network. Maintenance of infliximab treatment in ankylosing spondylitis: results of a one-year randomized controlled trial comparing systematic versus on-demand treatment. Arthritis Rheum. 2008 Jan;58(1):88-97. doi: 10.1002/art.23167.
PMID: 18163509DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maxime DOUGADOS, Professor
ARCR
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 22, 2007
First Posted
February 23, 2007
Study Start
April 1, 2003
Study Completion
December 1, 2004
Last Updated
February 27, 2007
Record last verified: 2007-02