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Axial SpondyloarthritisPhase 4ROC-SPANCT03445845

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

A Phase 4 study testing Secukinumab, TNF blocker and blood specimen in people with Axial Spondyloarthritis, run by Centre Hospitalier Universitaire de Saint Etienne at 35 sites in 2 countries.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Axial Spondyloarthritis
What is being tested?
Secukinumab, TNF blocker and blood specimen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
35 sitesin 2 countries
Study dates
14 Dec 2018to 1 Oct 2024
Phase
Phase 4
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

  • 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
Show all 9Show fewer
  • Ability to complete questionnaires
  • Social security affiliation
  • Informed written consent given

Who cannot join

  • 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

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

France34 sites

  • CHU d'Angers

    Angers

  • CHRU Besançon

    Besançon

  • APHP- Hôpital Avicenne

    Bobigny

  • CHU Bordeaux

    Bordeau

  • CHRU Brest

    Brest

  • CHU Clermont-Ferrand

    Clermont-Ferrand

  • CHU de Grenoble Alpes

    Grenoble

  • CHD Vendée

    La Roche-sur-Yon

  • CH Le Mans

    Le Mans

  • CHRU Lille

    Lille

  • Hôpital Saint-Philibert

    Lomme

  • CH Lyon SUD

    Lyon

  • Hôpital Edouard Herriot

    Lyon

  • CHRU Montpellier

    Montpellier

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

    Montpellier

  • CHU Nancy

    Nancy

  • CHU de Nantes

    Nantes

  • CHU de Nice

    Nice

  • CHR d'Orléans

    Orléans

  • APHP - Hôpital Ambroise Paré

    Paris

  • APHP - Hôpital Bichat

    Paris

  • APHP - Hôpital Cochin

    Paris

  • APHP - Hôpital Henri Mondor

    Paris

  • APHP - Hôpital Lariboisière

    Paris

  • APHP - Hôpital Pitié-Salpétrière

    Paris

  • APHP - Hôpital Saint-Antoine

    Paris

  • APHP - Kremlin-Bicêtre

    Paris

  • CHU de Poitiers

    Poitiers

  • CHU Reims

    Reims

  • CHU de Rouen

    Rouen

  • CHU Saint-Etienne

    Saint-Etienne, 42055

  • CHU STRASBOURG - Hautepierre

    Strasbourg, 67200

  • CHU Toulouse

    Toulouse

  • CHRU Tours

    Tours

Other trials in France

Monaco1 site

  • CH Princesse de Grace

    Monaco

Other trials in Monaco

About this study

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.

Being tested
Secukinumab, TNF blocker, blood specimen
Keywords
TNF blocker, change of biotherapy
Medical subject headings
Axial Spondyloarthritis

What participants receive

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

  • SecukinumabDrug

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

  • TNF blockerDrug

    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.

  • blood specimenBiological

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

Study groups in NCT03445845
Study groupRoleWhat they receive
targeting IL-23/17 axisExperimentalThe 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
Receives: Drug: Secukinumab; Biological: blood specimen
TNF blockerActive comparator• 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
Receives: Drug: TNF blocker; Biological: blood specimen

What is being measured

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

  1. 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

    Measured: 24 weks

Secondary outcomes (17)

  1. 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

    Measured: 12 weeks

  2. 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

    Measured: 52 weeks

  3. 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

    Measured: 52 weeks

  4. 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

    Measured: 24 weeks

  5. 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

    Measured: 52 weeks

  6. 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."

    Measured: 12 weeks

  7. 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."

    Measured: 24 weeks

  8. 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."

    Measured: 52 weeks

  9. Proportion of axSpA patients with a ASDAS major improvement at week 12

    ASDAS major improvement was defined by a variation of ASDAS-CRP≥2

    Measured: 12 weeks

  10. Proportion of axSpA patients with a ASDAS major improvement at week 24

    ASDAS major improvement was defined by a variation of ASDAS-CRP≥2

    Measured: 24 weeks

  11. Proportion of axSpA patients with a ASDAS major improvement at week 52

    ASDAS major improvement was defined by a variation of ASDAS-CRP≥2

    Measured: 52 weeks

  12. 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

    Measured: 12 weeks

  13. 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

    Measured: 24 weeks

  14. 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

    Measured: 52 weeks

  15. Number of adverse events

    Number of adverse events

    Measured: 52 weeks

  16. 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

    Measured: From baseline to 52 weeks

  17. 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

    Measured: From baseline to 52 weeks

Timeline

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

  1. First posted26 Feb 2018
  2. Study start14 Dec 2018
  3. Primary completion21 Sep 2024
  4. Study completion1 Oct 2024

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03445845
Sponsor's protocol ID
1608185
Other IDs
2017-004700-22, 2017
Acronym
ROC-SPA
Status last verified
Nov 2024
First submitted
20 Feb 2018
Last updated
18 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dalix E, Marcelli C, Bejan-Angoulvant T, Finckh A, Rancon F, Akrour M, De Araujo L, Presles E, Marotte H; ROC-SpA study group. Rotation or change of biotherapy after TNF blocker treatment failure for axial spondyloarthritis: the ROC-SpA study, a randomised controlled study protocol. BMJ Open. 2024 Sep 10;14(9):e087872. doi: 10.1136/bmjopen-2024-087872.

    PubMed 39260856

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Secukinumab, TNF blocker and blood specimen in people with Axial Spondyloarthritis, run by Centre Hospitalier Universitaire de Saint Etienne at 35 sites in 2 countries.

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 9 inclusion and 7 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 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in France, Monaco. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Proportion of axSpA patients with a clinical response Assessments in Ankylosing Spondylitis International Society 40 (ASAS 40) at week 24 (time frame: 24 weks). 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 NCT03445845, which also lists 1 linked publication.

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 18 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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