Spondylitis, AnkylosingPRESANCT03033095
Prediction of the Answer to the Treatment by Biotherapies for Naive Spondyloarthritis by Combinatorial Analysis of Serum Biomarkers
A study testing Etanercept ® 50 mg in people with Spondylitis, Ankylosing, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The aim of this trial is the caracterisation of a predicting algorithm of the answering response for patients with etanercept treatment in spondyloarthritis disease. This algorithm will help to target patients patients who have a risk / benefit important for etanercept treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spondylitis, Ankylosing
- What is being tested?
- Etanercept ® 50 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to 28 Mar 2018
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with spondylarthritis validating ASAS or New York modified critera, and for who etanercept is indicated.
- Naïve from biological Drug Modifying Anti Rheumatic Drugs
- patients between 18 and 70 years old
- patients who can be monitored at 6 months ;
- patients who can observe the entire treatment ;
- patiens with age to procreate under effective contraception ((abstinence, oral contraceptives , intrauterine devices , implants, spermicide or surgical sterilization ) during the study and for 6 months, 3 weeks after the last injection.
Show all 9Show fewer
- patients able to understand and accept the terms of the study
- patients having signed the informed consent.
- patients insured under social security
Who cannot join
- patients of age protected ;
- patients with difficulties for understanding french language ;
- patients with high function disorders incompatible with an education program (dementia Alzheimer's type , etc ...) ;
- patients with psycho- social instability incompatible with regular monitoring (homeless , addictive behavior ,etc.) ;
- patients in a socio- professional situation incompatible with optimal attendance to the program - - Pregnant or nursing patients
- patients who received previously a biotherapy treatment . There is no other exclusion criteria taking into account previous treatments and the duration of them.
Show all 9Show fewer
- contraindication to the use of anti- TNF treatment
- Surgery scheduled during the study.
- Persons mentioned in Articles L.1121-5 to L.1121-8 of the Public Health Code
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of the Answer to the Treatment by Biotherapies for Naive Spondyloarthritis Disease During 6 Months by Combinatorial Analysis of Serum Biomarkers
The aim of this trial is the caracterisation of a predicting algorithm of the answering response for patients with etanercept treatment in spondyloarthritis disease.
This algorithm will help to target patients patients who have a risk / benefit important for etanercept treatment.
Read the detailed description
Spondyloarthritis (or spondyloarthropathy) is an inflammatory rheumatic disease that causes arthritis. It differs from other types of arthritis because it involves the sites where ligaments and tendons are attached to bones called "entheses."
All patients should get physical therapy and make exercises for joints. Exercises that promote spinal extension and mobility are the most recommended.
Non-steroidal anti-inflammatory drugs (NSAIDs) are the first line treatment for spondylarthritis. NSAIDs are effective when they are used continuously or at the request, in a short or long-term use. However, physicians have to be aware of potential cardiovascular, renal or gastro-intestinal secondary effects when they prescribe NSAIDs. After NSAIDs failure, TNF inhibitors can be used, like infliximab or etanercept. Before starting an anti-TNF treatment, a screening is mandatory. Indeed, patients treated with an anti-TNF must be followed regularly. Until now, there is no algorithm which can predict the response to TNF-inhibitors, and more especially for etanercept treatment.
In this clinical trial, the investigators want to caracterise an algorithm which can predict the response to etanercept for a cohort of patients who suffer from spondyloarthritis.
The development of a predictive algorithm for etanercept treatment will be set up from biological data and finalized with the availibility of clinical data (M6) of the patients .
A modelling by logistic regression will be used, incorporing the set of available variables.
In this clinical trial, the investigators want to caracterise an algorithm which can predict the response to TNF-inhibitors for a cohort of patients with Spondyloarthritis and for an indicated treatment of etanercept.
- Conditions
- Spondylitis, Ankylosing
- Being tested
- Etanercept ® 50 mg
- Keywords
- TNF inhibitor, Etanercept, Spondyloarthritis, Biomarkers analysis, Personnalized medicine
- Medical subject headings
- Spondylitis, Ankylosing, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etanercept ® 50 mgDrug
Also called ENBREL
The etanercept is not the experimental study drug. Etanercept is a treatment justifying the inclusion of patients and is used in accordance with its marketing authorization.
| Study group | Role | What they receive |
|---|---|---|
| etanercept | Experimental | The etanercept is not the experimental study drug. Etanercept is a treatment justifying the inclusion of patients and is used in accordance with its marketing authorization.
Modality of administration :
Etanercept : 50 mg / week subcutaneously, every 7 days The clinical response will be evaluated after 6 months of etanercept treatment, at the M6 visit. Receives: Drug: Etanercept ® 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of disease activity with AS- DAS score (Ankylosing Spondylitis - Disease Activity Score )
An important clinical ASAS response, corresponds to a variation of the ASDAS CRP ≥ 1.1
Measured: 6 months after inclusion
Secondary outcomes (2)
Measurement of BASDAI response
Sensitivity and specificity of the algorithm for BASDAI response : BASDAI response 50, that means an improvement of BASDAI response of 50% or more
Measured: 6 months after inclusion
biomarkers analysis for personalized medicine
8 biomarkers will be analysed :
- calcium-binding protein complex S100A8/A9,
- prealbumin,
- haptoglobin (Hapto),
- protéine C-réactive (CRP),
- α1 anti-trypsin
- apolipoprotéinA1 (ApoA1),
- platelet factor 4 (PF4),
- S100A12 protein,
Measured: at the inclusion and 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionJul 2017
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spondylitis, AnkylosingStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Athan BAILLET, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033095
- Sponsor's protocol ID
- 38RC16.018
- Acronym
- PRESA
- Status last verified
- Jun 2022
- First submitted
- 11 May 2016
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Aaltonen KJ, Virkki LM, Malmivaara A, Konttinen YT, Nordstrom DC, Blom M. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS One. 2012;7(1):e30275. doi: 10.1371/journal.pone.0030275. Epub 2012 Jan 17.
PubMed 22272322Braun J, Sieper J. Biological therapies in the spondyloarthritides--the current state. Rheumatology (Oxford). 2004 Sep;43(9):1072-84. doi: 10.1093/rheumatology/keh205. Epub 2004 Jun 8.
PubMed 15187239Kristensen LE, Saxne T, Nilsson JA, Geborek P. Impact of concomitant DMARD therapy on adherence to treatment with etanercept and infliximab in rheumatoid arthritis. Results from a six-year observational study in southern Sweden. Arthritis Res Ther. 2006;8(6):R174. doi: 10.1186/ar2084.
PubMed 17121678
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the Answer to the Treatment by Biotherapies for Naive Spondyloarthritis Disease During 6 Months by Combinatorial Analysis of Serum Biomarkers
- ClinicalTrials.gov ID
- NCT03033095
- Acronym / sponsor ID
- PRESA / 38RC16.018
- Conditions
- Spondylitis, Ankylosing
- Keywords
- TNF inhibitor, Etanercept, Spondyloarthritis, Biomarkers analysis, Personnalized medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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.
The aim of this trial is the caracterisation of a predicting algorithm of the answering response for patients with etanercept treatment in spondyloarthritis disease.
This algorithm will help to target patients patients who have a risk / benefit important for etanercept treatment.
Detailed description
Spondyloarthritis (or spondyloarthropathy) is an inflammatory rheumatic disease that causes arthritis. It differs from other types of arthritis because it involves the sites where ligaments and tendons are attached to bones called "entheses."
All patients should get physical therapy and make exercises for joints. Exercises that promote spinal extension and mobility are the most recommended.
Non-steroidal anti-inflammatory drugs (NSAIDs) are the first line treatment for spondylarthritis. NSAIDs are effective when they are used continuously or at the request, in a short or long-term use. However, physicians have to be aware of potential cardiovascular, renal or gastro-intestinal secondary effects when they prescribe NSAIDs. After NSAIDs failure, TNF inhibitors can be used, like infliximab or etanercept. Before starting an anti-TNF treatment, a screening is mandatory. Indeed, patients treated with an anti-TNF must be followed regularly. Until now, there is no algorithm which can predict the response to TNF-inhibitors, and more especially for etanercept treatment.
In this clinical trial, the investigators want to caracterise an algorithm which can predict the response to etanercept for a cohort of patients who suffer from spondyloarthritis.
The development of a predictive algorithm for etanercept treatment will be set up from biological data and finalized with the availibility of clinical data (M6) of the patients .
A modelling by logistic regression will be used, incorporing the set of available variables.
In this clinical trial, the investigators want to caracterise an algorithm which can predict the response to TNF-inhibitors for a cohort of patients with Spondyloarthritis and for an indicated treatment of etanercept.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| etanercept | Experimental | Drug: Etanercept ® 50 mgThe etanercept is not the experimental study drug. Etanercept is a treatment justifying the inclusion of patients and is used in accordance with its marketing authorization. Modality of administration : Etanercept : 50 mg / week subcutaneously, every 7 days The clinical response will be evaluated after 6 months of etanercept treatment, at the M6 visit. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- patients with spondylarthritis validating ASAS or New York modified critera, and for who etanercept is indicated.
- Naïve from biological Drug Modifying Anti Rheumatic Drugs
- patients between 18 and 70 years old
- patients who can be monitored at 6 months ;
- patients who can observe the entire treatment ;
Key exclusion criteria (9 listed)
- patients of age protected ;
- patients with difficulties for understanding french language ;
- patients with high function disorders incompatible with an education program (dementia Alzheimer's type , etc ...) ;
- patients with psycho- social instability incompatible with regular monitoring (homeless , addictive behavior ,etc.) ;
- patients in a socio- professional situation incompatible with optimal attendance to the program - - Pregnant or nursing patients
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 |
|---|---|---|
| Etanercept ® 50 mgAlso: ENBRELThe etanercept is not the experimental study drug. Etanercept is a treatment justifying the inclusion of patients and is used in accordance with its marketing authorization. | Drug | etanercept |
Primary outcome
Measurement of disease activity with AS- DAS score (Ankylosing Spondylitis - Disease Activity Score )
Time frame: 6 months after inclusion
An important clinical ASAS response, corresponds to a variation of the ASDAS CRP ≥ 1.1
2 secondary outcomes
Measurement of BASDAI response
Time frame: 6 months after inclusion
biomarkers analysis for personalized medicine
Time frame: at the inclusion and 6 months after
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 14 Jun 2022.
- Background: PubMed 22272322Aaltonen KJ, Virkki LM, Malmivaara A, Konttinen YT, Nordstrom DC, Blom M. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS One. 2012;7(1):e30275. doi: 10.1371/journal.pone.0030275. Epub 2012 Jan 17.
- Background: PubMed 15187239Braun J, Sieper J. Biological therapies in the spondyloarthritides--the current state. Rheumatology (Oxford). 2004 Sep;43(9):1072-84. doi: 10.1093/rheumatology/keh205. Epub 2004 Jun 8.
- Background: PubMed 17121678Kristensen LE, Saxne T, Nilsson JA, Geborek P. Impact of concomitant DMARD therapy on adherence to treatment with etanercept and infliximab in rheumatoid arthritis. Results from a six-year observational study in southern Sweden. Arthritis Res Ther. 2006;8(6):R174. doi: 10.1186/ar2084.
- Individual participant dataSharing planned: No
Related trials for Spondylitis, Ankylosing
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis
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.
Athan BAILLET principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etanercept ® 50 mg in people with Spondylitis, Ankylosing, run by University Hospital, Grenoble at 1 site in France.
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 9 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 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
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?
Measurement of disease activity with AS- DAS score (Ankylosing Spondylitis - Disease Activity Score ) (time frame: 6 months after inclusion). 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 NCT03033095, which also lists 3 linked publications.
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 14 Jun 2022.