Trial · NCT03561649
Prediction of Treatment Response at 6 Months by Combinatorial Analysis of Serum Biomarkers in Biotherapy Naive SpA
NCT03561649, Not applicable, Completed, University Hospital, Grenoble
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prediction of Treatment Response at 6 Months by Combinatorial Analysis of Serum Biomarkers in Biotherapy Naive SpA. Trials, record NCT03561649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03561649
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prediction of Treatment Response at 6 Months by Combinatorial Analysis of Serum Biomarkers in Biotherapy Naive SpA
- NCT number
- NCT03561649
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 50 participants, actual
- Lead sponsor
- University Hospital, Grenoble
- Conditions
- Spondylitis, Ankylosing
- Interventions
- Adalimumab
- First posted
- 2018-06-19
- Last updated
- 2026-05-27
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measurement of disease activity: AS-DAS (Ankylosing Spondylitis - Disease Activity Score) | 6 months after baseline | The primary endpoint is the clinically important ASAS response corresponding to a variation in ASDAS CRP ≥ 1.1. |
| Secondary | Measurement of BASDAI response (Bath Ankylosing Spondylitis Disease Activity Index) | 6 months after baseline | The major clinical ASAS response corresponds to a variation in ASDAS CRP (C-reactive protein) ≥ 2,0 and the major clinical BASDAI 50 response. The BASDAI 50 response means an improvement of the BASDAI score by 50% or more. C-Reactive Protein (CRP) in mg/l and Erythrocyte Sedimentation Rate (ESR) in mm at the first hour. |
| Secondary | Biomarkers analysis for personalized medicine | At baseline and 6 months later | Blood draw for selected biomarkers analysis (M0): the dosage data will be used to search for biomarkers associated with successful treatment in order to generate an algorithm predicting the response to adalimumab at 6 months, and to define the metrological properties on this cohort. Blood draw for selected biomarkers analysis (M6): we know little about the mechanisms underlying the effect of adalimumab treatment at 6 months in spondyloarthritis, particularly on the biomarker profile. In order to identify possible differences in the profile of selected biomarkers between patients treated with adalimumab at 6 months and biotherapy naive patients (at baseline) and to study the individual variations of the response to this treatment, blood samples will also be collected at 6 months. By using proteomic profiles, the analysis and the comparison of predictive factors at M0 and M6 could be very useful. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers26
The papers the trial lists on ClinicalTrials.gov.
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/NCT03561649
GET https://conductscience.org/api/trials/v1/NCT03561649/papers?page=2