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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004700-22 | EudraCT Number |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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:
Blood specimen at each visits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug | Secukinumab : 150 mg per week for 5 weeks, and then every month by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 24 weks |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hubert MAROTTE, MD | Centre Hospitalier Universitaire de Saint Etienne | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Angers | France | ||||
| CHRU Besançon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39260856 | Derived | 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. |
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| TNF blocker | Drug | TNF blocker (originator or biosimilar) :
|
|
| blood specimen | Biological | Blood specimen at each visits for measurement of bDMARS blockers concentration and anti-drug antibody concentration |
|
| 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:
| 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:
| 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:
| 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:
| 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:
| 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:
| 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:
| 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 | 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 | 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 | 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 | 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 | 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 | 52 weeks |
| Number of adverse events | Number of adverse events | 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 | 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 | From baseline to 52 weeks |
| Besançon |
| France |
| APHP- Hôpital Avicenne | Bobigny | France |
| CHU Bordeaux | Bordeau | France |
| CHRU Brest | Brest | France |
| CHU Clermont-Ferrand | Clermont-Ferrand | France |
| CHU de Grenoble Alpes | Grenoble | France |
| CHD Vendée | La Roche-sur-Yon | France |
| CH Le Mans | Le Mans | France |
| CHRU Lille | Lille | France |
| Hôpital Saint-Philibert | Lomme | France |
| CH Lyon SUD | Lyon | France |
| Hôpital Edouard Herriot | Lyon | France |
| CHRU Montpellier | Montpellier | France |
| CHU Montpellier - 2 - Unité Clinique thérapeutique des Maladies Ostéo-Articulaires | Montpellier | France |
| CHU Nancy | Nancy | France |
| CHU de Nantes | Nantes | France |
| CHU de Nice | Nice | France |
| CHR d'Orléans | Orléans | France |
| APHP - Hôpital Ambroise Paré | Paris | France |
| APHP - Hôpital Bichat | Paris | France |
| APHP - Hôpital Cochin | Paris | France |
| APHP - Hôpital Henri Mondor | Paris | France |
| APHP - Hôpital Lariboisière | Paris | France |
| APHP - Hôpital Pitié-Salpétrière | Paris | France |
| APHP - Hôpital Saint-Antoine | Paris | France |
| APHP - Kremlin-Bicêtre | Paris | France |
| CHU de Poitiers | Poitiers | France |
| CHU Reims | Reims | France |
| CHU de Rouen | Rouen | France |
| CHU Saint-Etienne | Saint-Etienne | 42055 | France |
| CHU STRASBOURG - Hautepierre | Strasbourg | 67200 | France |
| CHU Toulouse | Toulouse | France |
| CHRU Tours | Tours | France |
| CH Princesse de Grace | Monaco | Monaco |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
| D000079424 | Tumor Necrosis Factor Inhibitors |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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