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

NCT03445845 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-11-18

No results posted yet for this 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.

Conditions

  • Axial Spondyloarthritis

Interventions

DRUG

Secukinumab

Secukinumab : 150 mg per week for 5 weeks, and then every month by subcutaneous injection

DRUG

TNF blocker

TNF blocker (originator or biosimilar) : * infliximab: 5mg/kg per IV infusion at weeks 0, 2, 6, and then every 6 weeks, * etanercept: 50mg per week in subcutaneous injection, * adalimumab: 40mg every other week in subcutaneous injection, * certolizumab: 400mg every other week 3 times, and then 200mg every other week or 400mg per month in subcutaneous injections, * golimumab: 50mg every month in subcutaneous injection, in case of overweight (\>100kg) an inadequate response, 100mg every month is allow.

BIOLOGICAL

blood specimen

Blood specimen at each visits for measurement of bDMARS blockers concentration and anti-drug antibody concentration

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Hubert MAROTTE, MD · CHU SAINT-ETIENNE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-14
Primary Completion
2024-09-21
Completion
2024-10-01

Countries

  • France
  • Monaco

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03445845 on ClinicalTrials.gov