Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis

Last updated: November 15, 2024
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Completed

Phase

4

Condition

Ankylosing Spondylitis

Treatment

blood specimen

TNF blocker

Secukinumab

Clinical Study ID

NCT03445845
1608185
2017-004700-22
  • Ages > 18
  • All Genders

Study Summary

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease characterized by inflammatory arthritis and enthesitis involving the spine. AxSpA prevalence is around 0.17% of the French population. Tumor necrosis factor (TNF) was the first target defined in axSpA. Since one third of axSpA patients failed to the first TNF blocker, many axSpA patients received a second biological Disease-Modifying AntiRheumatic Drugs (bDMARDs). Until few months, the only choice was to use a second TNF blocker.Since 2003, pharmaceutical companies investigated efficacy of TNF blockers already used in rheumatoid arthritis. Etanercept is a fusion protein with TNF receptor type II p75 and IgG1 Fc fragment, whereas adalimumab, infliximab, and golimumab are monoclonal antibodies. Certolizumab is a fusion between a fab fragment targeting TNF and a Peg fraction. All demonstrated efficacy versus placebo in a randomized double blinded study

In case of failure to the first TNF blockers, rheumatologists will follow the "Treat-to-Target" principle. This approach already demonstrated its benefit in rheumatoid arthritis or in psoriatic arthritis. This concept was also suggested for axSpA with low levels of evidence and recommendation. So rheumatologist will provide the best treatment in case of failure to the first TNF blockers, which is a daily clinical situation. Since few months, rheumatologists have the choice between targeting IL-23/17 axis compared to a second TNF blocker.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Active axSPA with BASDAI>4 or ASDAS>3.5, who need change in TNF blocker treatment

  • Aged over 18 years

  • Inadequate response after at least 3 months to the 1st TNF blocker

  • If non biologic DMARD treatment : stable dose for at least on month before inclusion

  • If oral corticosteroids treatment : stable dose for at least on month beforeinclusion

  • If NSAIDs treatment : stable dose for at least on month before inclusion

  • Ability to complete questionnaires

  • Social security affiliation

  • Informed written consent given

Exclusion

Exclusion Criteria:

  • Any contra-indication to TNF blocker and/or secukinumab

  • Inflammatory bowel diseases

  • Existing pregnancy, lactation, or intended pregnancy within the next 15 monthsActive tuberculosis or other severe infections such as sepsis or opportunisticinfections

  • Active infections, including chronic or localised infections.

  • Moderate to severe heart failure (NYHA classes III/IV)

  • Impossibility to give informed consent

  • Impossibility to be followed for 12 months

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: blood specimen
Phase: 4
Study Start date:
December 14, 2018
Estimated Completion Date:
October 01, 2024

Connect with a study center

  • CHU Amiens

    Amiens,
    France

    Site Not Available

  • CHU d'Angers

    Angers,
    France

    Site Not Available

  • CHRU Besançon

    Besançon,
    France

    Site Not Available

  • APHP- Hôpital Avicenne

    Bobigny,
    France

    Site Not Available

  • CHU Bordeaux

    Bordeau,
    France

    Site Not Available

  • CHRU Brest

    Brest,
    France

    Site Not Available

  • CHU Clermont-Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • CHU de Grenoble Alpes

    Grenoble,
    France

    Site Not Available

  • CHD Vendée

    La Roche-sur-Yon,
    France

    Site Not Available

  • CH Le Mans

    Le Mans,
    France

    Site Not Available

  • CH Le Puy en Velay

    Le Puy-en-Velay,
    France

    Site Not Available

  • CHRU Lille

    Lille,
    France

    Site Not Available

  • Hôpital Saint-Philibert

    Lomme,
    France

    Site Not Available

  • CH Lyon SUD

    Lyon,
    France

    Site Not Available

  • Hôpital Edouard Herriot

    Lyon,
    France

    Site Not Available

  • APHM - Hôpital Sainte-Marguerite Rhumatologie 1

    Marseille,
    France

    Site Not Available

  • CHRU Montpellier

    Montpellier,
    France

    Site Not Available

  • CHU Montpellier - 2 - Unité Clinique thérapeutique des Maladies Ostéo-Articulaires

    Montpellier,
    France

    Site Not Available

  • CHU Nancy

    Nancy,
    France

    Site Not Available

  • CHU de Nantes

    Nantes,
    France

    Site Not Available

  • CHU de Nice

    Nice,
    France

    Site Not Available

  • CHR d'Orléans

    Orléans,
    France

    Site Not Available

  • APHP - Hôpital Ambroise Paré

    Paris,
    France

    Site Not Available

  • APHP - Hôpital Bichat

    Paris,
    France

    Site Not Available

  • APHP - Hôpital Cochin

    Paris,
    France

    Site Not Available

  • APHP - Hôpital Henri Mondor

    Paris,
    France

    Site Not Available

  • APHP - Hôpital Lariboisière

    Paris,
    France

    Site Not Available

  • APHP - Hôpital Pitié-Salpétrière

    Paris,
    France

    Site Not Available

  • APHP - Hôpital Saint-Antoine

    Paris,
    France

    Site Not Available

  • APHP - Kremlin-Bicêtre

    Paris,
    France

    Site Not Available

  • CH Lyon Sud

    Pierre-Bénite,
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers,
    France

    Site Not Available

  • CHU Reims

    Reims,
    France

    Site Not Available

  • CHU de Rouen

    Rouen,
    France

    Site Not Available

  • CHU Saint-Etienne

    Saint-Étienne, 42055
    France

    Site Not Available

  • CHU STRASBOURG - Hautepierre

    Strasbourg, 67200
    France

    Site Not Available

  • CHU Toulouse

    Toulouse,
    France

    Site Not Available

  • CHRU Tours

    Tours,
    France

    Site Not Available

  • CH Princesse de Grace

    Monaco,
    Monaco

    Site Not Available

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