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Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
infliximab
methotrexate
Sponsored by
Association de Recherche Clinique en Rhumatologie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Ankylosing spondylitis, infliximab, Systematic regimen, On-demand regimen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CHU Amiens
  • CHU Hôpital Minjoz
  • Hôpital Avicenne
  • Hôpital Pellegrin
  • Hôpital Ambroise Paré
  • CHU de la Cavale Blanche
  • CHU Côte de Nacre
  • Hôpital Gilles de Corbeil
  • Hôpital Henri Mondor
  • Hôpital Général
  • CHU A. Michallon
  • Groupe Hospitalier du Havre
  • Hôpital Bicêtre
  • CHRU Hôpital Roger Salengro
  • CHU Dupuytren
  • Centre Hospitalier Saint Philibert
  • CH St Joseph - St Luc
  • Hôpital de la Conception
  • Hôpital Lapeyronie
  • CHU l'Archet 1
  • Hôpital Porte Madeleine
  • Hôpital de la Pitié
  • Hôpital Cochin
  • CHU de Poitiers
  • CHU - Hôpital Sud
  • CHU - Hôpital de Bois Guillaume
  • CHU Saint-Etienne
  • CHU Hautepierre
  • Hôpital de Purpan
  • CHU Hôpital Trousseau
  • CHU Nancy-Brabois

Outcomes

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.

Full Information

First Posted
February 22, 2007
Last Updated
February 26, 2007
Sponsor
Association de Recherche Clinique en Rhumatologie
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1. Study Identification

Unique Protocol Identification Number
NCT00439283
Brief Title
Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis
Official Title
Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis: Comparison of Infusion Every 6 Weeks Versus Infusion on Demand
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Association de Recherche Clinique en Rhumatologie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Ankylosing spondylitis, infliximab, Systematic regimen, On-demand regimen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
infliximab
Intervention Type
Drug
Intervention Name(s)
methotrexate
Primary Outcome Measure Information:
Title
The primary end point was the proportion of patients with a 20% improvement response according to the ASAS criteria, at week 54.
Secondary Outcome Measure Information:
Title
Achievement of the ASAS50 and ASAS70.
Title
The proportion of patients who experienced a partial remission, according to ASAS definition.
Title
Improvement in independent components of the ASAS response criteria.
Title
BASDAI.
Title
SF-36.
Title
Schober test.
Title
Finger to floor test.
Title
Chest expansion score.
Title
Occiput-to-wall measurements.
Title
Acute-phase reactants (erythrocyte sedimentation rate and C-reactive protein level).
Title
Number of infusions administered after the loading regimen.
Title
Number of patients requiring an increase in the dose of infliximab.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxime DOUGADOS, Professor
Organizational Affiliation
ARCR
Official's Role
Study Director
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Hôpital Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital Ambroise Paré
City
Boulogne Billancourt
ZIP/Postal Code
92104
Country
France
Facility Name
CHU de la Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHU Côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Gilles de Corbeil
City
Corbeil Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hôpital Général
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU A. Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Groupe Hospitalier du Havre
City
Le Havre
ZIP/Postal Code
76083
Country
France
Facility Name
Hôpital Bicêtre
City
Le Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
CHRU Hôpital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Hospitalier Saint Philibert
City
Lomme
ZIP/Postal Code
59160
Country
France
Facility Name
CH St Joseph - St Luc
City
Lyon
ZIP/Postal Code
69365
Country
France
Facility Name
Hôpital de la Conception
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU l'Archet 1
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Porte Madeleine
City
Orléans
ZIP/Postal Code
45032
Country
France
Facility Name
Hôpital de la Pitié
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHU - Hôpital Sud
City
Rennes
ZIP/Postal Code
35056
Country
France
Facility Name
CHU - Hôpital de Bois Guillaume
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
CHU Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hôpital de Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Hôpital Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CHU Nancy-Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19740900
Citation
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.
Results Reference
derived
PubMed Identifier
18163509
Citation
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.
Results Reference
derived

Learn more about this trial

Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis

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