Rotation or Change of Biotherapy After TNF blocker treatment failure

Rotation or Change of Biotherapy After TNF blocker treatment failure for axial Spondyloarthritis: The ROC-SpA study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004700-22-FR

Enrollment

Unknown

Registered

2018-01-17

Start date

2018-02-26

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

axial Spondyloarthritis MedDRA version: 20.0 Level: PT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: cosentyx Pharmaceutical Form: Solution for injection Product Code: TNF Blocker Pharmaceutical Form: INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Current Sponsor code: inflixim

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Active axSPA with BASDAI>4 and 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 • IfNSAIDs treatment : stable dose for at least on month before inclusion • Ability to complete questionnaires • Social security affiliation • Informed written consent given Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Demonstrate that targeting IL-23/17 axis will provide a better clinical response at 24 weeks when compared to a second TNF blocker, after failure of a first TNF blocker in axSpA;Secondary Objective: 1- Targeting IL-23/17 axis compared to a second TNF blocker will provide: 1.a- A better clinical response after failure of a first TNF blocker in axSpA at weeks 12 and 52. 1.b- A better maintenance of bDMARDs. 2- To compare tolerance of both strategies. 3- To compare the incremental cost-effectiveness ratio (ICER) of the IL23/17 strategy versus the 2nd TNF-blocker strategy. 4- To compare quality-adjusted life-year (QALY) between both strategies. 5- Investigating whether the pharmacokinetic parameters of TNF blockers (serum trough levels concentrations, specific antibody concentrations) measured at inclusion are predictive of a clinical response at W24. 6- Investigating whether the pharmacokinetic parameters of bDMARDs (serum trough levels concentrations, specific antibody concentrations) are associated with low disease activity.;Primary end point(s): Proportion of axSpA patients with a clinical response ASAS40 at week 24. The ASAS working group has proposed a measure that has been now used in several trials to measure the efficacy of new products on the symptoms of axSpA. The ASAS Response Criteria (ASAS 40) is defined as an improvement of at least 40% and absolute improvement of at least 10 units on a 0-100 mm scale in at least 3 of the following domains compared to values at inclusion: • Patient global assessment measured on a VAS scale with extremes labelled “none” and “severe.” • Pain assessment represented by the average of total and nocturnal pain scores, both measured on a VAS 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 VAS with extremes labelled “easy” and “impossible.” • Morning stiffness, represented by the a	—

Measure

Time frame

Main Objective: Demonstrate that targeting IL-23/17 axis will provide a better clinical response at 24 weeks when compared to a second TNF blocker, after failure of a first TNF blocker in axSpA;Secondary Objective: 1- Targeting IL-23/17 axis compared to a second TNF blocker will provide: 1.a- A better clinical response after failure of a first TNF blocker in axSpA at weeks 12 and 52. 1.b- A better maintenance of bDMARDs. 2- To compare tolerance of both strategies. 3- To compare the incremental cost-effectiveness ratio (ICER) of the IL23/17 strategy versus the 2nd TNF-blocker strategy. 4- To compare quality-adjusted life-year (QALY) between both strategies. 5- Investigating whether the pharmacokinetic parameters of TNF blockers (serum trough levels concentrations, specific antibody concentrations) measured at inclusion are predictive of a clinical response at W24. 6- Investigating whether the pharmacokinetic parameters of bDMARDs (serum trough levels concentrations, specific antibody concentrations) are associated with low disease activity.;Primary end point(s): Proportion of axSpA patients with a clinical response ASAS40 at week 24. The ASAS working group has proposed a measure that has been now used in several trials to measure the efficacy of new products on the symptoms of axSpA. The ASAS Response Criteria (ASAS 40) is defined as an improvement of at least 40% and absolute improvement of at least 10 units on a 0-100 mm scale in at least 3 of the following domains compared to values at inclusion: • Patient global assessment measured on a VAS scale with extremes labelled “none” and “severe.” • Pain assessment represented by the average of total and nocturnal pain scores, both measured on a VAS 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 VAS with extremes labelled “easy” and “impossible.” • Morning stiffness, represented by the a

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Secondary

Measure	Time frame
Secondary end point(s): 1a/ Clinical response will also be assessed by the following criteria [22,30]: - ASAS40 response rates at week 12 and 52; - ASAS20 response rates at week 12, 24, and 52; The ASAS20 response is based on the same principle with an improvement of at least 20%. - Partial remission rates at week 12, 24, and 52; Partial remission is defined by values lower than 20/100 in each 4 domains described above. - ASDAS major improvement rates at week 12, 24, and 52; ASDAS major improvement was defined by a variation of ASDAS-CRP=2. 1b/ Maintenance rate of the bDMARDs will be compared in both strategies at week 12, 24, and 52. 2/ Tolerance of the treatment will be collected actively (specific questions on the different expected outcomes in the CRF) at each visit to the study with a focus on any kind of infection. Moreover, it will ask the patient to note on a booklet any side effects during the treatment to reduce the bias of memorisation. 3/ Medical direct and indirect costs will be compared in both strategies. The incremental cost-effectiveness ratio (ICER) of the IL-23/17 strategy versus the 2nd TNF-blocker strategy is defined as follows : ?(CoûtIL23/17 – Coût2nd TNF) / ?(Efficacité IL23/17 – Efficacité2nd TNF), in which direct and indirect costs will be elicited from the payer (national health insurance) perspective, and effectiveness expressed in quality-adjusted life years (QALY) and derived from the EQ-5D-5L using French norms [31].;Timepoint(s) of evaluation of this end point: week 12, 24, and 52	—

Measure

Time frame

Secondary end point(s): 1a/ Clinical response will also be assessed by the following criteria [22,30]: - ASAS40 response rates at week 12 and 52; - ASAS20 response rates at week 12, 24, and 52; The ASAS20 response is based on the same principle with an improvement of at least 20%. - Partial remission rates at week 12, 24, and 52; Partial remission is defined by values lower than 20/100 in each 4 domains described above. - ASDAS major improvement rates at week 12, 24, and 52; ASDAS major improvement was defined by a variation of ASDAS-CRP=2. 1b/ Maintenance rate of the bDMARDs will be compared in both strategies at week 12, 24, and 52. 2/ Tolerance of the treatment will be collected actively (specific questions on the different expected outcomes in the CRF) at each visit to the study with a focus on any kind of infection. Moreover, it will ask the patient to note on a booklet any side effects during the treatment to reduce the bias of memorisation. 3/ Medical direct and indirect costs will be compared in both strategies. The incremental cost-effectiveness ratio (ICER) of the IL-23/17 strategy versus the 2nd TNF-blocker strategy is defined as follows : ?(CoûtIL23/17 – Coût2nd TNF) / ?(Efficacité IL23/17 – Efficacité2nd TNF), in which direct and indirect costs will be elicited from the payer (national health insurance) perspective, and effectiveness expressed in quality-adjusted life years (QALY) and derived from the EQ-5D-5L using French norms [31].;Timepoint(s) of evaluation of this end point: week 12, 24, and 52

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Countries

France

Contacts

Public ContactProject manager

CHU Saint-Etienne

florence.rancon@chu-st-etienne.fr0477829458

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 5, 2026