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Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis (ROC-SPA)

Primary Purpose

Axial Spondyloarthritis

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Secukinumab
TNF blocker
blood specimen
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring TNF blocker, change of biotherapy

Eligibility Criteria

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

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 before inclusion
  • If NSAIDs treatment : stable dose for at least on month before inclusion
  • Ability to complete questionnaires
  • Social security affiliation
  • Informed written consent given

Exclusion Criteria:

  • Any contra-indication to TNF blocker and/or secukinumab
  • Inflammatory bowel diseases
  • Existing pregnancy, lactation, or intended pregnancy within the next 15 months Active tuberculosis or other severe infections such as sepsis or opportunistic infections
  • 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

Sites / Locations

  • CHU d'AngersRecruiting
  • CHRU BesançonRecruiting
  • APHP- Hôpital Avicenne
  • CHU BordeauxRecruiting
  • CHRU BrestRecruiting
  • CHU Clermont-FerrandRecruiting
  • CHU de Grenoble AlpesRecruiting
  • CHD VendéeRecruiting
  • CH Le MansRecruiting
  • CHRU Lille
  • Hôpital Saint-PhilibertRecruiting
  • CH Lyon SUDRecruiting
  • Hôpital Edouard HerriotRecruiting
  • CHRU MontpellierRecruiting
  • CHU Montpellier - 2 - Unité Clinique thérapeutique des Maladies Ostéo-ArticulairesRecruiting
  • CHU NancyRecruiting
  • CHU de NantesRecruiting
  • CHU de NiceRecruiting
  • CHR d'OrléansRecruiting
  • APHP - Hôpital Ambroise ParéRecruiting
  • APHP - Hôpital Bichat
  • APHP - Hôpital CochinRecruiting
  • APHP - Hôpital Henri MondorRecruiting
  • APHP - Hôpital Lariboisière
  • APHP - Hôpital Pitié-SalpétrièreRecruiting
  • APHP - Hôpital Saint-AntoineRecruiting
  • APHP - Kremlin-BicêtreRecruiting
  • CHU de PoitiersRecruiting
  • CHU ReimsRecruiting
  • CHU de RouenRecruiting
  • CHU Saint-EtienneRecruiting
  • CHU STRASBOURG - HautepierreRecruiting
  • CHU ToulouseRecruiting
  • CHRU ToursRecruiting
  • CH Princesse de GraceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

targeting IL-23/17 axis

TNF blocker

Arm Description

The experimental group (targeting IL-23/17 axis) receiving secukinumab in compliance with the marketing authorization regimen: 150 mg per week for 5 weeks, and then every month by subcutaneous injection. Blood specimen at each visits

• The control group receiving a second TNF blocker in compliance with the marketing authorization regimen: The TNF blocker (originator or biosimilar) will be different to the TNF used before the inclusion and will be chose by the investigator: 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. Blood specimen at each visits

Outcomes

Primary Outcome Measures

Proportion of axSpA patients with a clinical response Assessments in Ankylosing Spondylitis International Society 40 (ASAS 40) at week 24
ASAS 40 is defined as an improvement of at least 40% and absolute improvement of at least 2 units on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion: Patient global assessment : numerical rating scale with extremes labelled "none" and "severe." Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function : BASFI average of 10 questions measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening at all in remaining domain

Secondary Outcome Measures

Proportion of axSpA patients with a clinical response ASAS 40 at week 12
ASAS 40 is defined as an improvement of at least 40% and absolute improvement of at least 2 units on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion: Patient global assessment : numerical rating scale with extremes labelled "none" and "severe." Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function : BASFI average of 10 questions measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening at all in remaining domain
Proportion of axSpA patients with a clinical response ASAS 40 at week 52
ASAS 40 is defined as an improvement of at least 40% and absolute improvement of at least 2 units on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion: Patient global assessment : numerical rating scale with extremes labelled "none" and "severe." Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function : BASFI average of 10 questions measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening at all in remaining domain
Proportion of axSpA patients with a clinical response ASAS 20 at week 12
ASAS 20 is defined as an improvement of at least 20% and absolute improvement of at least 1 unit on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion: Patient global assessment : numerical rating scale with extremes labelled "none" and "severe." Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function : BASFI average of 10 questions regarding measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening in a similar amount in the fourth domain
Proportion of axSpA patients with a clinical response ASAS 20 at week 24
ASAS 20 is defined as an improvement of at least 20% and absolute improvement of at least 1 unit on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion: Patient global assessment : numerical rating scale with extremes labelled "none" and "severe." Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function : BASFI average of 10 questions regarding measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening in a similar amount in the fourth domain
Proportion of axSpA patients with a clinical response ASAS20 at week 52
ASAS 20 is defined as an improvement of at least 20% and absolute improvement of at least 1 unit on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion: Patient global assessment : numerical rating scale with extremes labelled "none" and "severe." Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function : BASFI average of 10 questions regarding measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening in a similar amount in the fourth domain
Proportion of axSpA patients with a partial remission rate at week 12
Partial remission is defined by values lower than 2/10 in each 4 domains: Patient global assessment measured on a numerical rating scale with extremes labelled "none" and "severe." Pain assessment represented by the average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI regarding morning stiffness as measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours."
Proportion of axSpA patients with a partial remission rate at week 24
Partial remission is defined by values lower than 2/10 in each 4 domains: Patient global assessment measured on a numerical rating scale with extremes labelled "none" and "severe." Pain assessment represented by the average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI regarding morning stiffness as measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours."
Proportion of axSpA patients with a partial remission rate at week 52
Partial remission is defined by values lower than 2/10 in each 4 domains: Patient global assessment measured on a numerical rating scale with extremes labelled "none" and "severe." Pain assessment represented by the average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI regarding morning stiffness as measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours."
Proportion of axSpA patients with a ASDAS major improvement at week 12
ASDAS major improvement was defined by a variation of ASDAS-CRP≥2
Proportion of axSpA patients with a ASDAS major improvement at week 24
ASDAS major improvement was defined by a variation of ASDAS-CRP≥2
Proportion of axSpA patients with a ASDAS major improvement at week 52
ASDAS major improvement was defined by a variation of ASDAS-CRP≥2
Proportion of axSpA patients with biological Disease-Modifying AntiRheumatic Drugs (bDMARDs) treatment at week 12
Patient with the same bDAMRs treatment at inclusion and week 12
Proportion of axSpA patients with biological Disease-Modifying AntiRheumatic Drugs (bDMARDs) treatment at week 24
Patient with the same biological Disease-Modifying AntiRheumatic Drug (bDAMR) treatment at inclusion and week 24
Proportion of axSpA patients with bDMARDs treatment at week 52
Patient with the same biological Disease-Modifying AntiRheumatic Drug (bDAMR) treatment at inclusion and week 52
Number of adverse events
Number of adverse events
Correlation between concentration of antibodies to bDMARS blockers and clinical response according to treatment
Concentration of antibodies to bDMARS blockers is measured by Enzyme Linked ImmunoSorbent Assay (ELISA) low disease activity is defined by BASDAI <4 and ASDAS <2.1
Correlation between concentration of anti-drug antibodies and clinical response according to treatment
Concentration of anti-drug antibodies is measured by Enzyme Linked ImmunoSorbent Assay (ELISA) low disease activity is defined by BASDAI <4 and ASDAS <2.1

Full Information

First Posted
February 20, 2018
Last Updated
June 6, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT03445845
Brief Title
Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis
Acronym
ROC-SPA
Official Title
Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2018 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis
Keywords
TNF blocker, change of biotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
targeting IL-23/17 axis
Arm Type
Experimental
Arm Description
The experimental group (targeting IL-23/17 axis) receiving secukinumab in compliance with the marketing authorization regimen: 150 mg per week for 5 weeks, and then every month by subcutaneous injection. Blood specimen at each visits
Arm Title
TNF blocker
Arm Type
Active Comparator
Arm Description
• The control group receiving a second TNF blocker in compliance with the marketing authorization regimen: The TNF blocker (originator or biosimilar) will be different to the TNF used before the inclusion and will be chose by the investigator: 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. Blood specimen at each visits
Intervention Type
Drug
Intervention Name(s)
Secukinumab
Intervention Description
Secukinumab : 150 mg per week for 5 weeks, and then every month by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
TNF blocker
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
blood specimen
Intervention Description
Blood specimen at each visits for measurement of bDMARS blockers concentration and anti-drug antibody concentration
Primary Outcome Measure Information:
Title
Proportion of axSpA patients with a clinical response Assessments in Ankylosing Spondylitis International Society 40 (ASAS 40) at week 24
Description
ASAS 40 is defined as an improvement of at least 40% and absolute improvement of at least 2 units on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion: Patient global assessment : numerical rating scale with extremes labelled "none" and "severe." Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function : BASFI average of 10 questions measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening at all in remaining domain
Time Frame
24 weks
Secondary Outcome Measure Information:
Title
Proportion of axSpA patients with a clinical response ASAS 40 at week 12
Description
ASAS 40 is defined as an improvement of at least 40% and absolute improvement of at least 2 units on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion: Patient global assessment : numerical rating scale with extremes labelled "none" and "severe." Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function : BASFI average of 10 questions measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening at all in remaining domain
Time Frame
12 weeks
Title
Proportion of axSpA patients with a clinical response ASAS 40 at week 52
Description
ASAS 40 is defined as an improvement of at least 40% and absolute improvement of at least 2 units on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion: Patient global assessment : numerical rating scale with extremes labelled "none" and "severe." Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function : BASFI average of 10 questions measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening at all in remaining domain
Time Frame
52 weeks
Title
Proportion of axSpA patients with a clinical response ASAS 20 at week 12
Description
ASAS 20 is defined as an improvement of at least 20% and absolute improvement of at least 1 unit on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion: Patient global assessment : numerical rating scale with extremes labelled "none" and "severe." Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function : BASFI average of 10 questions regarding measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening in a similar amount in the fourth domain
Time Frame
52 weeks
Title
Proportion of axSpA patients with a clinical response ASAS 20 at week 24
Description
ASAS 20 is defined as an improvement of at least 20% and absolute improvement of at least 1 unit on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion: Patient global assessment : numerical rating scale with extremes labelled "none" and "severe." Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function : BASFI average of 10 questions regarding measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening in a similar amount in the fourth domain
Time Frame
24 weeks
Title
Proportion of axSpA patients with a clinical response ASAS20 at week 52
Description
ASAS 20 is defined as an improvement of at least 20% and absolute improvement of at least 1 unit on a numerical rating scale of 10 in at least 3 of the following domains compared to values at inclusion: Patient global assessment : numerical rating scale with extremes labelled "none" and "severe." Pain assessment : average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function : BASFI average of 10 questions regarding measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours." Additionally, no worsening in a similar amount in the fourth domain
Time Frame
52 weeks
Title
Proportion of axSpA patients with a partial remission rate at week 12
Description
Partial remission is defined by values lower than 2/10 in each 4 domains: Patient global assessment measured on a numerical rating scale with extremes labelled "none" and "severe." Pain assessment represented by the average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI regarding morning stiffness as measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours."
Time Frame
12 weeks
Title
Proportion of axSpA patients with a partial remission rate at week 24
Description
Partial remission is defined by values lower than 2/10 in each 4 domains: Patient global assessment measured on a numerical rating scale with extremes labelled "none" and "severe." Pain assessment represented by the average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI regarding morning stiffness as measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours."
Time Frame
24 weeks
Title
Proportion of axSpA patients with a partial remission rate at week 52
Description
Partial remission is defined by values lower than 2/10 in each 4 domains: Patient global assessment measured on a numerical rating scale with extremes labelled "none" and "severe." Pain assessment represented by the average of total and nocturnal pain scores, both measured on a numerical rating scale with extremes labelled "no pain" and "most severe pain." Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by numerical rating scale with extremes labelled "easy" and "impossible." Morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI regarding morning stiffness as measured by numerical rating scale: one with extremes labelled "none" and "very severe"; the other marking duration of morning stiffness between "0" and "2 or more hours."
Time Frame
52 weeks
Title
Proportion of axSpA patients with a ASDAS major improvement at week 12
Description
ASDAS major improvement was defined by a variation of ASDAS-CRP≥2
Time Frame
12 weeks
Title
Proportion of axSpA patients with a ASDAS major improvement at week 24
Description
ASDAS major improvement was defined by a variation of ASDAS-CRP≥2
Time Frame
24 weeks
Title
Proportion of axSpA patients with a ASDAS major improvement at week 52
Description
ASDAS major improvement was defined by a variation of ASDAS-CRP≥2
Time Frame
52 weeks
Title
Proportion of axSpA patients with biological Disease-Modifying AntiRheumatic Drugs (bDMARDs) treatment at week 12
Description
Patient with the same bDAMRs treatment at inclusion and week 12
Time Frame
12 weeks
Title
Proportion of axSpA patients with biological Disease-Modifying AntiRheumatic Drugs (bDMARDs) treatment at week 24
Description
Patient with the same biological Disease-Modifying AntiRheumatic Drug (bDAMR) treatment at inclusion and week 24
Time Frame
24 weeks
Title
Proportion of axSpA patients with bDMARDs treatment at week 52
Description
Patient with the same biological Disease-Modifying AntiRheumatic Drug (bDAMR) treatment at inclusion and week 52
Time Frame
52 weeks
Title
Number of adverse events
Description
Number of adverse events
Time Frame
52 weeks
Title
Correlation between concentration of antibodies to bDMARS blockers and clinical response according to treatment
Description
Concentration of antibodies to bDMARS blockers is measured by Enzyme Linked ImmunoSorbent Assay (ELISA) low disease activity is defined by BASDAI <4 and ASDAS <2.1
Time Frame
From baseline to 52 weeks
Title
Correlation between concentration of anti-drug antibodies and clinical response according to treatment
Description
Concentration of anti-drug antibodies is measured by Enzyme Linked ImmunoSorbent Assay (ELISA) low disease activity is defined by BASDAI <4 and ASDAS <2.1
Time Frame
From baseline to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 before inclusion If NSAIDs treatment : stable dose for at least on month before inclusion Ability to complete questionnaires Social security affiliation Informed written consent given Exclusion Criteria: Any contra-indication to TNF blocker and/or secukinumab Inflammatory bowel diseases Existing pregnancy, lactation, or intended pregnancy within the next 15 months Active tuberculosis or other severe infections such as sepsis or opportunistic infections 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hubert MAROTTE, MD
Phone
04 77 12 76 49
Ext
+33
Email
hubert.marotte@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Florence RANCON
Ext
+33
Email
florence.rancon@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert MAROTTE, MD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Study Director
Facility Information:
Facility Name
CHU d'Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erick LEGRAND, PhD
Email
erlgrand@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Erick LEGRAND, PhD
Facility Name
CHRU Besançon
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Wendling, MD
First Name & Middle Initial & Last Name & Degree
Daniel Wendling, MD
First Name & Middle Initial & Last Name & Degree
Clément PRATI, MD
First Name & Middle Initial & Last Name & Degree
Xavier GUILLOT, MD
First Name & Middle Initial & Last Name & Degree
Frank VERHOEVEN, PhD
Facility Name
APHP- Hôpital Avicenne
City
Bobigny
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Semerano, MD
Facility Name
CHU Bordeaux
City
Bordeau
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Schaeverbeke, MD
First Name & Middle Initial & Last Name & Degree
Thierry Schaeverbeke, MD
Facility Name
CHRU Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie Devauchelle, MD
First Name & Middle Initial & Last Name & Degree
Valérie Devauchelle, MD
First Name & Middle Initial & Last Name & Degree
Dewi GUELLEC, MD
First Name & Middle Initial & Last Name & Degree
Alain SARAUX, MD
First Name & Middle Initial & Last Name & Degree
Maxime QUIVIGER, MD
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Tournadre, MD
First Name & Middle Initial & Last Name & Degree
Anne Tournadre, MD
Facility Name
CHU de Grenoble Alpes
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athan Baillet, MD PhD
First Name & Middle Initial & Last Name & Degree
Philippe Gaudin, MD
Facility Name
CHD Vendée
City
La Roche-sur-Yon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire CORMIER, MD
First Name & Middle Initial & Last Name & Degree
Vincent ANDRE, MD
First Name & Middle Initial & Last Name & Degree
Michel CAULIER, MD
First Name & Middle Initial & Last Name & Degree
Céline COZIC, MD
First Name & Middle Initial & Last Name & Degree
Emeline GAIGNEUX, MD
First Name & Middle Initial & Last Name & Degree
Alexia MICHAUT, MD
First Name & Middle Initial & Last Name & Degree
Stéphane VARIN, MD
Facility Name
CH Le Mans
City
Le Mans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle Dernis, MD
First Name & Middle Initial & Last Name & Degree
Emmanuelle Dernis, MD
First Name & Middle Initial & Last Name & Degree
Amélie Denis, MD
First Name & Middle Initial & Last Name & Degree
Guillaume Diriez, MD
First Name & Middle Initial & Last Name & Degree
Arthur VRIGNAUD, MD
Facility Name
CHRU Lille
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
René-Marc Flipo, MD
First Name & Middle Initial & Last Name & Degree
René-Marc Flipo, MD
Facility Name
Hôpital Saint-Philibert
City
Lomme
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tristan PASCART, MD PhD
First Name & Middle Initial & Last Name & Degree
Aurore PACAUD, MD
Facility Name
CH Lyon SUD
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabienne COURY, MD
First Name & Middle Initial & Last Name & Degree
Mathilde PRORIOL, MD
Facility Name
Hôpital Edouard Herriot
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roland CHAPURLAT, MD
First Name & Middle Initial & Last Name & Degree
Florence DUVERT, MD
Facility Name
CHRU Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cédric Lukas, MD
First Name & Middle Initial & Last Name & Degree
Cédric Lukas, MD
Facility Name
CHU Montpellier - 2 - Unité Clinique thérapeutique des Maladies Ostéo-Articulaires
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian JORGENSEN, MD
First Name & Middle Initial & Last Name & Degree
Rosanna FERREIRA LOPEZ, MD
First Name & Middle Initial & Last Name & Degree
Yves-Marie PERS, MD
Facility Name
CHU Nancy
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien Loeuille, MD
First Name & Middle Initial & Last Name & Degree
Damien Loeuille, MD
Facility Name
CHU de Nantes
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoît Le Goff, MD
First Name & Middle Initial & Last Name & Degree
Benoît Le Goff, MD
First Name & Middle Initial & Last Name & Degree
Thomas Garraud, MD
First Name & Middle Initial & Last Name & Degree
Yves Maugars, MD
Facility Name
CHU de Nice
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Roux, MD
First Name & Middle Initial & Last Name & Degree
Christian Roux, MD
Facility Name
CHR d'Orléans
City
Orléans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Lespessailles, MD
First Name & Middle Initial & Last Name & Degree
Eric Lespessailles, MD
First Name & Middle Initial & Last Name & Degree
Alexei Volguine, MD
Facility Name
APHP - Hôpital Ambroise Paré
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime Breban, MD
First Name & Middle Initial & Last Name & Degree
Maxime Breban, MD
First Name & Middle Initial & Last Name & Degree
Ariane Leboime Grigaut, MD
Facility Name
APHP - Hôpital Bichat
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Dieudé, MD
First Name & Middle Initial & Last Name & Degree
Philippe Dieudé, MD
Facility Name
APHP - Hôpital Cochin
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corinne Miceli, MD
First Name & Middle Initial & Last Name & Degree
Corinne Miceli, MD
Facility Name
APHP - Hôpital Henri Mondor
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Claudepierre, MD
First Name & Middle Initial & Last Name & Degree
Pascal Claudepierre, MD
Facility Name
APHP - Hôpital Lariboisière
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Richette, MD
First Name & Middle Initial & Last Name & Degree
Pascal Richette, MD
Facility Name
APHP - Hôpital Pitié-Salpétrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure Gossec
First Name & Middle Initial & Last Name & Degree
Laure Gossec, MD
First Name & Middle Initial & Last Name & Degree
Béatrice Banneville, MD
Facility Name
APHP - Hôpital Saint-Antoine
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérémie Sellam, MD
First Name & Middle Initial & Last Name & Degree
Jérémie Sellam, MD
First Name & Middle Initial & Last Name & Degree
Camille Deprouw, MD
First Name & Middle Initial & Last Name & Degree
Sandra DESOUCHES, MD
Facility Name
APHP - Kremlin-Bicêtre
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Pavy, MD
First Name & Middle Initial & Last Name & Degree
Stephan Pavy, MD
First Name & Middle Initial & Last Name & Degree
Rabika Belkhir, MD
First Name & Middle Initial & Last Name & Degree
Frédéric Desmoulins, MD
First Name & Middle Initial & Last Name & Degree
Julien Henry, MD
First Name & Middle Initial & Last Name & Degree
Gaetane Nocturne, MD
First Name & Middle Initial & Last Name & Degree
Raphaèle Seror, MD
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Solau, MD
First Name & Middle Initial & Last Name & Degree
Elisabeth Solau, MD
Facility Name
CHU Reims
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Hugues SALMON, MD PhD
First Name & Middle Initial & Last Name & Degree
Loïs BOLKO, MD
First Name & Middle Initial & Last Name & Degree
Isabelle CHARLOT LAMBRECHT, MD
First Name & Middle Initial & Last Name & Degree
Marion GEOFFROY, MD
First Name & Middle Initial & Last Name & Degree
Ambre HITTINGER-ROUX, MD
First Name & Middle Initial & Last Name & Degree
Loïc PAUVELE, MD
Facility Name
CHU de Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Lequerré, MD
First Name & Middle Initial & Last Name & Degree
Thierry Lequerré, MD
First Name & Middle Initial & Last Name & Degree
Sophie Pouplin, MD
Facility Name
CHU Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hubert Marotte, MD
Phone
+33 4 77 12 76 49
Email
hubert.marotte@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Hubert Marotte, MD
Facility Name
CHU STRASBOURG - Hautepierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renaud FELTEN, MD
First Name & Middle Initial & Last Name & Degree
Renaud FELTEN, MD
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud Constantin, MD
First Name & Middle Initial & Last Name & Degree
Arnaud Constantin, MD
Facility Name
CHRU Tours
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Goupille, MD
First Name & Middle Initial & Last Name & Degree
Saloua Mammou-Mraghni, MD
First Name & Middle Initial & Last Name & Degree
Jessica René, MD
Facility Name
CH Princesse de Grace
City
Monaco
Country
Monaco
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Brocq, MD
First Name & Middle Initial & Last Name & Degree
Olivier Brocq, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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