Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis

February 26, 2007 updated by: Association de Recherche Clinique en Rhumatologie

Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis: Comparison of Infusion Every 6 Weeks Versus Infusion on Demand

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Besançon, France, 25030
        • CHU Hôpital Minjoz
      • Bobigny, France, 93009
        • Hôpital Avicenne
      • Bordeaux, France, 33076
        • Hôpital Pellegrin
      • Boulogne Billancourt, France, 92104
        • Hopital Ambroise Pare
      • Brest, France, 29609
        • CHU de la Cavale Blanche
      • Caen, France, 14033
        • CHU côte de Nacre
      • Corbeil Essonnes, France, 91106
        • Hôpital Gilles de Corbeil
      • Creteil, France, 94010
        • Hopital Henri Mondor
      • Dijon, France, 21000
        • Hôpital Général
      • Grenoble, France, 38043
        • CHU A. Michallon
      • Le Havre, France, 76083
        • Groupe Hospitalier Du Havre
      • Le Kremlin Bicêtre, France, 94275
        • Hôpital Bicêtre
      • Lille, France, 59037
        • CHRU Hôpital Roger Salengro
      • Limoges, France, 87042
        • Chu Dupuytren
      • Lomme, France, 59160
        • Centre Hospitalier Saint Philibert
      • Lyon, France, 69365
        • CH St Joseph - St Luc
      • Marseille, France, 13385
        • Hôpital de la Conception
      • Montpellier, France, 34295
        • Hôpital Lapeyronie
      • Nice, France, 06202
        • CHU l'Archet 1
      • Orléans, France, 45032
        • Hopital Porte Madeleine
      • Paris, France, 75014
        • Hopital Cochin
      • Paris, France, 75013
        • Hôpital de la Pitié
      • Poitiers, France, 86021
        • CHU De Poitiers
      • Rennes, France, 35056
        • CHU - Hôpital Sud
      • Rouen, France, 76031
        • CHU - Hôpital de Bois Guillaume
      • Saint-Etienne, France, 42055
        • CHU Saint-Etienne
      • Strasbourg, France, 67098
        • CHU HautePierre
      • Toulouse, France, 31059
        • Hôpital de Purpan
      • Tours, France, 37044
        • CHU Hôpital Trousseau
      • Vandoeuvre Les Nancy, France, 54511
        • CHU Nancy-Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary end point was the proportion of patients with a 20% improvement response according to the ASAS criteria, at week 54.

Secondary Outcome Measures

Outcome Measure
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association de Recherche Clinique en Rhumatologie

Investigators

  • Study Director: Maxime DOUGADOS, Professor, ARCR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

February 22, 2007

First Submitted That Met QC Criteria

February 22, 2007

First Posted (Estimate)

February 23, 2007

Study Record Updates

Last Update Posted (Estimate)

February 27, 2007

Last Update Submitted That Met QC Criteria

February 26, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A R C R 2003 - 01 / PO 3353

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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