Trial · NCT03445845
Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis
NCT03445845, Phase 4, Completed, Centre Hospitalier Universitaire de Saint Etienne
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis. Trials, record NCT03445845. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03445845
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis
- NCT number
- NCT03445845
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 300 participants, actual
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Conditions
- Axial Spondyloarthritis
- Interventions
- Secukinumab, TNF blocker, blood specimen
- First posted
- 2018-02-26
- Last updated
- 2024-11-18
- Other registries' IDs
- eudract:2017-004700-22
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of axSpA patients with a clinical response Assessments in Ankylosing Spondylitis International Society 40 (ASAS 40) at week 24 | 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 |
| Secondary | Proportion of axSpA patients with a clinical response ASAS 40 at week 12 | 12 weeks | 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 | Proportion of axSpA patients with a clinical response ASAS 40 at week 52 | 52 weeks | 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 | Proportion of axSpA patients with a clinical response ASAS 20 at week 12 | 52 weeks | 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 |
| Secondary | Proportion of axSpA patients with a clinical response ASAS 20 at week 24 | 24 weeks | 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 |
| Secondary | Proportion of axSpA patients with a clinical response ASAS20 at week 52 | 52 weeks | 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 |
| Secondary | Proportion of axSpA patients with a partial remission rate at week 12 | 12 weeks | 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." |
| Secondary | Proportion of axSpA patients with a partial remission rate at week 24 | 24 weeks | 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." |
| Secondary | Proportion of axSpA patients with a partial remission rate at week 52 | 52 weeks | 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." |
| Secondary | Proportion of axSpA patients with a ASDAS major improvement at week 12 | 12 weeks | ASDAS major improvement was defined by a variation of ASDAS-CRP≥2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39260856 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03445845
GET https://conductscience.org/api/trials/v1/NCT03445845/registered