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

Search all trials

Trial summary

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.

Country

City, postcode or hospital

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.

Conditions: Axial Spondyloarthritis
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 group	Role	What they receive
targeting IL-23/17 axis	Experimental	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 Receives: Drug: Secukinumab; Biological: blood specimen
TNF blocker	Active 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.

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)

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
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
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
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
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
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
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
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
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
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
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
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
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
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
Number of adverse events
Number of adverse events
Measured: 52 weeks
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
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.

14 Dec 20181 Oct 2024

First posted26 Feb 2018
Study start14 Dec 2018
Primary completion21 Sep 2024
Study completion1 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Axial Spondyloarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis
ClinicalTrials.gov ID: NCT03445845
Acronym / sponsor ID: ROC-SPA / 1608185
Conditions: Axial Spondyloarthritis
Keywords: TNF blocker, change of biotherapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
Collaborators: Ministry of Health, France
Study start: 14 Dec 2018 (actual)
Primary completion: 21 Sep 2024 (actual)
Study completion: 1 Oct 2024 (actual)
First posted: 26 Feb 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
targeting IL-23/17 axis	Experimental	Drug: Secukinumab, Biological: blood specimenThe 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
TNF blocker	Active comparator	Drug: TNF blocker, Biological: blood specimen• 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SecukinumabSecukinumab : 150 mg per week for 5 weeks, and then every month by subcutaneous injection	Drug	targeting IL-23/17 axis
TNF blockerTNF 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.	Drug	TNF blocker
blood specimenBlood specimen at each visits for measurement of bDMARS blockers concentration and anti-drug antibody concentration	Biological	TNF blocker, targeting IL-23/17 axis

Primary outcome

Proportion of axSpA patients with a clinical response Assessments in Ankylosing Spondylitis International Society 40 (ASAS 40) at week 24
Time frame: 24 weks
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

17 secondary outcomes

Proportion of axSpA patients with a clinical response ASAS 40 at week 12
Time frame: 12 weeks
Proportion of axSpA patients with a clinical response ASAS 40 at week 52
Time frame: 52 weeks
Proportion of axSpA patients with a clinical response ASAS 20 at week 12
Time frame: 52 weeks
Proportion of axSpA patients with a clinical response ASAS 20 at week 24
Time frame: 24 weeks
Proportion of axSpA patients with a clinical response ASAS20 at week 52
Time frame: 52 weeks
Proportion of axSpA patients with a partial remission rate at week 12
Time frame: 12 weeks
Proportion of axSpA patients with a partial remission rate at week 24
Time frame: 24 weeks
Proportion of axSpA patients with a partial remission rate at week 52
Time frame: 52 weeks
Proportion of axSpA patients with a ASDAS major improvement at week 12
Time frame: 12 weeks
Proportion of axSpA patients with a ASDAS major improvement at week 24
Time frame: 24 weeks
Proportion of axSpA patients with a ASDAS major improvement at week 52
Time frame: 52 weeks
Proportion of axSpA patients with biological Disease-Modifying AntiRheumatic Drugs (bDMARDs) treatment at week 12
Time frame: 12 weeks
Proportion of axSpA patients with biological Disease-Modifying AntiRheumatic Drugs (bDMARDs) treatment at week 24
Time frame: 24 weeks
Proportion of axSpA patients with bDMARDs treatment at week 52
Time frame: 52 weeks
Number of adverse events
Time frame: 52 weeks
Correlation between concentration of antibodies to bDMARS blockers and clinical response according to treatment
Time frame: From baseline to 52 weeks
Correlation between concentration of anti-drug antibodies and clinical response according to treatment
Time frame: From baseline to 52 weeks

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
Derived from this study: PubMed 39260856Dalix 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hubert MAROTTE, MD study director

Centre Hospitalier Universitaire de Saint Etienne

35 sites in 2 countries: see every site and its status.

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.