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Ankylosing SpondylitisPhase 3NCT00439283

Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis

A Phase 3 study testing infliximab and methotrexate in people with Ankylosing Spondylitis, run by Association de Recherche Clinique en Rhumatologie at 31 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
infliximab and methotrexate
How many people
240 participants
Where
31 sitesFrance
Study dates
Apr 2003to Dec 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

France31 sites

  • CHU Amiens

    Amiens, 80054

  • CHU Hôpital Minjoz

    Besançon, 25030

  • Hôpital Avicenne

    Bobigny, 93009

  • Hôpital Pellegrin

    Bordeaux, 33076

  • Hôpital Ambroise Paré

    Boulogne-Billancourt, 92104

  • CHU de la Cavale Blanche

    Brest, 29609

  • CHU Côte de Nacre

    Caen, 14033

  • Hôpital Gilles de Corbeil

    Corbeil-Essonnes, 91106

  • Hôpital Henri Mondor

    Créteil, 94010

  • Hôpital Général

    Dijon, 21000

  • CHU A. Michallon

    Grenoble, 38043

  • Groupe Hospitalier du Havre

    Le Havre, 76083

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275

  • CHRU Hôpital Roger Salengro

    Lille, 59037

  • CHU Dupuytren

    Limoges, 87042

  • Centre Hospitalier Saint Philibert

    Lomme, 59160

  • CH St Joseph - St Luc

    Lyon, 69365

  • Hôpital de la Conception

    Marseille, 13385

  • Hôpital Lapeyronie

    Montpellier, 34295

  • CHU l'Archet 1

    Nice, 06202

  • Hôpital Porte Madeleine

    Orléans, 45032

  • Hôpital de la Pitié

    Paris, 75013

  • Hôpital Cochin

    Paris, 75014

  • CHU de Poitiers

    Poitiers, 86021

  • CHU - Hôpital Sud

    Rennes, 35056

  • CHU - Hôpital de Bois Guillaume

    Rouen, 76031

  • CHU Saint-Etienne

    Saint-Etienne, 42055

  • CHU Hautepierre

    Strasbourg, 67098

  • Hôpital de Purpan

    Toulouse, 31059

  • CHU Hôpital Trousseau

    Tours, 37044

  • CHU Nancy-Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: 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.

Read the 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.

Keywords
Ankylosing spondylitis, infliximab, Systematic regimen, On-demand regimen
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. Achievement of the ASAS50 and ASAS70.

  2. The proportion of patients who experienced a partial remission, according to ASAS definition.

  3. Improvement in independent components of the ASAS response criteria.

  4. BASDAI.

  5. SF-36.

  6. Schober test.

  7. Finger to floor test.

  8. Chest expansion score.

  9. Occiput-to-wall measurements.

  10. Acute-phase reactants (erythrocyte sedimentation rate and C-reactive protein level).

  11. Number of infusions administered after the loading regimen.

  12. Number of patients requiring an increase in the dose of infliximab.

  13. 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.

  14. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2007 (estimated)
  2. Study startApr 2003
  3. Study completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00439283
Sponsor's protocol ID
A R C R 2003 - 01 / PO 3353
Status last verified
Feb 2007
First submitted
22 Feb 2007
Last updated
27 Feb 2007
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19740900

  • 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.

    PubMed 18163509

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing infliximab and methotrexate in people with Ankylosing Spondylitis, run by Association de Recherche Clinique en Rhumatologie at 31 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary end point was the proportion of patients with a 20% improvement response according to the ASAS criteria, at week 54.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00439283, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2007.

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