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Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis

This study has been completed.
Sponsor:
Information provided by:
Association de Recherche Clinique en Rhumatologie
ClinicalTrials.gov Identifier:
NCT00439283
First received: February 22, 2007
Last updated: February 26, 2007
Last verified: February 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Ankylosing Spondylitis
 Drug: infliximab
Drug: methotrexate
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Association de Recherche Clinique en Rhumatologie:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 240
Study Start Date: April 2003
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439283

Locations
France
CHU Amiens
Amiens, France, 80054
CHU Hôpital Minjoz
Besançon, France, 25030
Hôpital Avicenne
Bobigny, France, 93009
Hôpital Pellegrin
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
Hôpital Général
Dijon, France, 21000
CHU A. Michallon
Grenoble, France, 38043
Groupe Hospitalier du Havre
Le Havre, France, 76083
Hôpital Bicêtre
Le Kremlin Bicêtre, France, 94275
CHRU Hôpital Roger Salengro
Lille, France, 59037
CHU Dupuytren
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
Hôpital Lapeyronie
Montpellier, France, 34295
CHU l'Archet 1
Nice, France, 06202
Hôpital Porte Madeleine
Orléans, France, 45032
Hôpital de la Pitié
Paris, France, 75013
Hôpital Cochin
Paris, France, 75014
CHU de Poitiers
Poitiers, France, 86021
CHU - Hôpital Sud
Rennes, France, 35056
CHU - Hôpital de Bois Guillaume
Rouen, France, 76031
CHU Saint-Etienne
Saint-Etienne, France, 42055
CHU Hautepierre
Strasbourg, France, 67098
Hôpital de Purpan
Toulouse, France, 31059
CHU Hôpital Trousseau
Tours, France, 37044
CHU Nancy-Brabois
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
Association de Recherche Clinique en Rhumatologie
Investigators
Study Director: Maxime DOUGADOS, Professor ARCR
  More Information

No publications provided by Association de Recherche Clinique en Rhumatologie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00439283     History of Changes
Other Study ID Numbers: A R C R 2003 - 01 / PO 3353
Study First Received: February 22, 2007
Last Updated: February 26, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Association de Recherche Clinique en Rhumatologie:
Ankylosing spondylitis
infliximab
Systematic regimen
On-demand regimen

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Methotrexate
Infliximab
Abortifacient Agents, Nonsteroidal
 Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013