Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis

NCT ID: NCT00439283

Last Updated: 2007-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2004-12-31

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.

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. 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.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing spondylitis; infliximab; Systematic regimen; On-demand regimen

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

infliximab

Intervention Type: DRUG

methotrexate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association de Recherche Clinique en Rhumatologie

OTHER

Sponsor Role: lead

Principal Investigators

Maxime DOUGADOS, Professor

Role: STUDY_DIRECTOR

ARCR

Locations

CHU Amiens

Amiens, , France

CHU Hôpital Minjoz

Besançon, , France

Hôpital Avicenne

Bobigny, , France

Hôpital Pellegrin

Bordeaux, , France

Hôpital Ambroise Paré

Boulogne-Billancourt, , France

CHU de la Cavale Blanche

Brest, , France

CHU Côte de Nacre

Caen, , France

Hôpital Gilles de Corbeil

Corbeil-Essonnes, , France

Hôpital Henri Mondor

Créteil, , France

Hôpital Général

Dijon, , France

CHU A. Michallon

Grenoble, , France

Groupe Hospitalier du Havre

Le Havre, , France

Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

CHRU Hôpital Roger Salengro

Lille, , France

CHU Dupuytren

Limoges, , France

Centre Hospitalier Saint Philibert

Lomme, , France

CH St Joseph - St Luc

Lyon, , France

Hôpital de la Conception

Marseille, , France

Hôpital Lapeyronie

Montpellier, , France

CHU l'Archet 1

Nice, , France

Hôpital Porte Madeleine

Orléans, , France

Hôpital de la Pitié

Paris, , France

Hôpital Cochin

Paris, , France

CHU de Poitiers

Poitiers, , France

CHU - Hôpital Sud

Rennes, , France

CHU - Hôpital de Bois Guillaume

Rouen, , France

CHU Saint-Etienne

Saint-Etienne, , France

CHU Hautepierre

Strasbourg, , France

Hôpital de Purpan

Toulouse, , France

CHU Hôpital Trousseau

Tours, , France

CHU Nancy-Brabois

Vandœuvre-lès-Nancy, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 19740900 (View on PubMed)

Breban 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.

Reference Type: DERIVED

PMID: 18163509 (View on PubMed)

Other Identifiers

A R C R 2003 - 01 / PO 3353

Identifier Type: -

Identifier Source: org_study_id