Juvenile Idiopathic ArthritisEtaplusNCT02030613
Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis
A study testing Blood test in people with Juvenile Idiopathic Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine the optimal dosage of etanercept in patients treated for idiopathic juvenile arthritis Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2013to 30 Mar 2017
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient with Juvenile Idiopathic Arthritis
- Age <18 years and> 4 years (which corresponds to the pediatric AMM)
- Patient on Etanercept treatment in the context of his usual care, whatever the dose (but the dose should remain stable in the weight during the study period). The patient must have received at least one injection of etanercept before participating in the study.
- Signature of consent by the guardians of the child
- Patient affiliate or entitled to a social security scheme
Who cannot join
- Infection progressive
- Pregnancy and lactation. For adolescents of reproductive age and sexually active, contraception should be used during the duration of treatment with etanercept
- Contraindication to treatment with Etanercept
- Refusal of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis
The purpose of this study is to determine the optimal dosage of etanercept in patients treated for idiopathic juvenile arthritis
Read the detailed description
Etanercept, a fully human soluble tumor necrosis factor (TNF) receptor fusion protein, has been demonstrated to be safe and efficacious for the treatment of patients with polyarticular JIA. However, many patients experience primary or secondary response failure, suggesting that individualization of treatment regimens may be beneficial. It has been shown that the clinical response to two anti-TNFalpha biological agents (infliximab, adalimumab) closely follows the trough drug levels and the presence of antibodies directed against the drugs. This study was undertaken to investigate whether serologic monitoring of etanercept bioavailability and immunogenicity in individual patients with JIA would be useful in optimizing treatment regimens to improve efficacy and tolerability
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Blood test
- Keywords
- juvenile idiopathic arthritis, etanercept
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testGenetic
| Study group | Role | What they receive |
|---|---|---|
| Single arm: etanercept | Other | Patients treated with etanercept for JIA Receives: Genetic: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Etanercept concentration-time courses
estimate etanercept population pharmacokinetic parameters and concentration-effect(s) relationship(s) in patients younger than 18 years treated for juvenile idiopathic arthritis (JIA).
Measured: one year
Secondary outcomes (5)
Wallace criteria
Evaluation of a clinical remission of Juvenile Idiopathic Arthritis (JIA). This measures one the different effects that could be related to the etenercept pharmacokinetics
Measured: one year
anti-etanercept antibodies levels
To evaluate their influence on plasma etanercept
Measured: one year
analogical visual scale
global activity of JIA, evaluated by the investigator. This measures one the different effects that could be related to the etenercept pharmacokinetics
Measured: one year
arthritis number
This measures one the different effects that could be related to the etenercept pharmacokinetics
Measured: one year
number of limited joints
This measures one the different effects that could be related to the etenercept pharmacokinetics
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study start1 Oct 2013
- Primary completion28 Feb 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Brigitte Bader-Meunier, MD, PhD, Principal investigator, Necker Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030613
- Sponsor's protocol ID
- P111102
- Acronym
- Etaplus
- Status last verified
- Sep 2025
- First submitted
- 13 Aug 2013
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Bader-Meunier B, Krzysiek R, Lemelle I, Pajot C, Carbasse A, Poignant S, Melki I, Quartier P, Choupeaux L, Henry E, Treluyer JM, Belot A, Hacein-Bey-Abina S, Urien S. Etanercept concentration and immunogenicity do not influence the response to Etanercept in patients with juvenile idiopathic arthritis. Semin Arthritis Rheum. 2019 Jun;48(6):1014-1018. doi: 10.1016/j.semarthrit.2018.09.002. Epub 2018 Sep 17.
PubMed 30396593
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT02030613
- Acronym / sponsor ID
- Etaplus / P111102
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- juvenile idiopathic arthritis, etanercept
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 8 Jan 2014 (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 purpose of this study is to determine the optimal dosage of etanercept in patients treated for idiopathic juvenile arthritis
Detailed description
Etanercept, a fully human soluble tumor necrosis factor (TNF) receptor fusion protein, has been demonstrated to be safe and efficacious for the treatment of patients with polyarticular JIA. However, many patients experience primary or secondary response failure, suggesting that individualization of treatment regimens may be beneficial. It has been shown that the clinical response to two anti-TNFalpha biological agents (infliximab, adalimumab) closely follows the trough drug levels and the presence of antibodies directed against the drugs. This study was undertaken to investigate whether serologic monitoring of etanercept bioavailability and immunogenicity in individual patients with JIA would be useful in optimizing treatment regimens to improve efficacy and tolerability
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm: etanercept | Other | Genetic: Blood testPatients treated with etanercept for JIA |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patient with Juvenile Idiopathic Arthritis
- Age <18 years and> 4 years (which corresponds to the pediatric AMM)
- Patient on Etanercept treatment in the context of his usual care, whatever the dose (but the dose should remain stable in the weight during the study period). The patient must have received at least one injection of etanercept before participating in the study.
- Signature of consent by the guardians of the child
- Patient affiliate or entitled to a social security scheme
Key exclusion criteria (4 listed)
- Infection progressive
- Pregnancy and lactation. For adolescents of reproductive age and sexually active, contraception should be used during the duration of treatment with etanercept
- Contraindication to treatment with Etanercept
- Refusal of the study
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 |
|---|---|---|
| Blood test | Genetic | Single arm: etanercept |
Primary outcome
Etanercept concentration-time courses
Time frame: one year
estimate etanercept population pharmacokinetic parameters and concentration-effect(s) relationship(s) in patients younger than 18 years treated for juvenile idiopathic arthritis (JIA).
5 secondary outcomes
Wallace criteria
Time frame: one year
anti-etanercept antibodies levels
Time frame: one year
analogical visual scale
Time frame: one year
arthritis number
Time frame: one year
number of limited joints
Time frame: one year
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 20 Nov 2025.
- Results publication: PubMed 30396593Bader-Meunier B, Krzysiek R, Lemelle I, Pajot C, Carbasse A, Poignant S, Melki I, Quartier P, Choupeaux L, Henry E, Treluyer JM, Belot A, Hacein-Bey-Abina S, Urien S. Etanercept concentration and immunogenicity do not influence the response to Etanercept in patients with juvenile idiopathic arthritis. Semin Arthritis Rheum. 2019 Jun;48(6):1014-1018. doi: 10.1016/j.semarthrit.2018.09.002. Epub 2018 Sep 17.
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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.
Brigitte Bader-Meunier, MD, PhD principal investigator
Necker Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Juvenile Idiopathic Arthritis, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 4 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 20 Nov 2025. 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?
Etanercept concentration-time courses (time frame: one year). 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 NCT02030613, which also lists 1 linked publication.
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 20 Nov 2025.