Systemic-Onset Juvenile Idiopathic ArthritisPhase 2/3NCT00339157
Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITIS
A Phase 2/3 study testing Anakinra and Pneumo23 in people with Systemic-Onset Juvenile Idiopathic Arthritis, run by Institut National de la Santé Et de la Recherche Médicale, France at 6 sites in France.
Trial summary
1. Main objective: To test the efficacy of anakinra treatment in children or young adults with corticosteroid-resistant or -dependent Systemic-Onset Juvenile Idiopathic Arthritis (SO-JIA) 2. Read more about this study
- Who is it for?
- Ages 2 to 20 years
- Conditions the study is for
- Systemic-Onset Juvenile Idiopathic Arthritis
- What is being tested?
- Anakinra and Pneumo23
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 6 sitesFrance
- Study dates
- 11 May 2006to 10 Jun 2008
- Phase
- Phase 2/3
- 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 2 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- SO-JIA (Edmonton's revision of Durban's consensus conference criteria)
- Age: at least 2 years and less than 20 years at treatment initiation
- Disease duration of at least 6 months
- Failure of corticosteroid treatment or requirement for corticosteroid treatment at a daily dose equal to or over 0.3 mg/kg (10 mg in patients whose weight is over 34 kg)
- Active and severe systemic symptoms and/or arthritis as assessed by an experienced pediatric Rheumatologists, with at least 3 of the following criteria when assessing Giannini's core-set items: 1) physician global assessment of disease activity of at least 20/100; 2) parent/patient assessment of disease effect on overall well-being of at least 20/100; 3) functional disability with a Children Health Assessment Questionnaire (CHAQ, Ref [9]) score equal to or higher than 0.375/3; 4) 2 joints or more with active arthritis 5) 2 joints or more with non-irreversible limited range of motion (irreversible limited range of motion will be defined by radiological evidence of irreversible joint damage and ankylosis) 6) erythrocyte sedimentation rate (ESR) equal to or higher than 20.
- In the absence of disease-related fever, either CRP or first hour ESR or both have to be over the upper limit of normal values so that treatment effect on the systemic part of the disease can be objectively evaluated.
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- Patients with polyarthritis (at least 5 joints with inflammation and/or limitation of motion) will be eligible for this study only if at least 50% of the affected joints do not present radiological evidence of irreversible damage.
- Informed consent signed by the parents or the person legally responsible for the patient if the patient is less than 18, and by the patient if old enough
- Teenager girls or young women with childbearing potential must use a contraceptive method (including abstinence
- tuberculin test performed before Day 1 and must either be negative or positivity must be related to previous immunization and of normal intensity according to the investigator's judgment
Who cannot join
- Previous treatment with IL-1Ra
- intra-articular injection or change in the doses of non-steroidal anti-inflammatory drugs and corticosteroids in the 4 weeks preceding the initiation of anakinra treatment
- Treatment with another immunosuppressive or disease-modifying drugs that could not be stopped before inclusion (for a duration depending on the drug pharmacokinetic properties)
- Contra-indication to the use of anakinra including ongoing active infection or allergy to E Coli's derivate or other components of the drug
- Previous history of malignancy or heart insufficiency
- Patients with asthma require to be previously assessed by a pneumonologist
- Obvious need of therapeutic intervention before study completion such as surgery, intra-articular injection, life vaccine administration
- Any of the following: leucocyte counts < 3.6 x 10e9/L, polymorphonuclear neutrophil counts < 1.5 x 10e9/L, platelets < 150 000/mm3, serum creatinin > 1.5 the upper limit of normal range for age, serum alanine and aspartate transaminases > 2 times the upper limit of the normal range, serum bilirubin > 2 times the upper limit of the normal range
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Bordeaux CHU
Bordeaux, 33000
Hopital Lyon Edouard Herriot
Lyon, 69437
Nancy Hopital d'Enfants
Nancy, 54511
Pediatric Immuno-Hematology and Rheumatology Unit, Necker-Enfants Malades Hospital, 149 rue de Sevres
Paris, 75015
Robert Debre Hospital
Paris, 75019
Kremlin-Bicetre Hospital
Paris, 94270
About this study
Official title: ANAkinra in Severe Juvenile Idiopathic Arthritis of Systemic Onset (ANAJIS)
- Main objective: To test the efficacy of anakinra treatment in children or young adults with corticosteroid-resistant or -dependent Systemic-Onset Juvenile Idiopathic Arthritis (SO-JIA)
- Design: Double blind, randomized trial testing the efficacy of one month Anakinra treatment versus placebo (2 groups of 12 patients each). All the patients will be treated with anakinra during the following 11 months and the dose of corticosteroids will be gradually tapered (= descriptive part of the trial to assess the tolerance and efficacy over 12 months).
- Hypothesis: 70% significant improvement after 1 month in Anakinra-treated patients versus no more than 10% in the placebo group.
- Main inclusion criteria : diagnosis of SO-JIA (Durban consensus conference criteria), age: 2 to 20 years at inclusion, active, corticosteroid-resistant or -dependent disease, no previous IL-1ra treatment.
- Being tested
- Anakinra, Pneumo23, Placebo
- Keywords
- IDIOPATHIC JUVENILE ARTHRITIS, PEDIATRICS, ORPHAN DISEASE, INTERLEUKIN - 1, RECEPTORS , INTERLEUKINS, ANTAGONISTS
- Medical subject headings
- Arthritis, Juvenile, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Pneumo23Biological
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Teatment with ANAKINRA (2 mg/kg SC daily, maximum 100 mg) | Active comparator | Anakinra is injected subcutaneously once a day , for a dosage of 2 mg/kg per day with a maximum of 100 mg per day. The dose should be administered at approximately the same time every day. The treatment should be administered with no interruption during the whole study period. Receives: Drug: Anakinra; Biological: Pneumo23 |
| Placebo treatment | Placebo comparator | Placebo is injected subcutaneously once a day using the same volume as the anakina treatment (dosage of 2 mg/kg per day of anakinra with a maximum of 100 mg per day). The dose should be administered at approximately the same time every day. The placebo treatment should be administered with no interruption during the whole study period. Receives: Biological: Pneumo23; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
30% improvement of JIA activity after 1 month compared to day 1 according to Giannini's core-set criteria, ie 30% improvement of at least 3 of the 6 items and no more than one item worsened by 30% or more.
Measured: Day 1, 1 Month
Number of active arthritis
Measured: Day 1, 1 Month
Number of joints with limitation of motion
Measured: Day 1, 1 Month
Physician assessment of disease activity
Measured: Day 1, 1 Month
Parent or patient's assessment of disease activity
Measured: Day 1, 1 Month
Childhood health assessment questionnaire
Measured: Day 1, 1 Month
First hour ESR)
Measured: First hour
Improvement of systemic symptoms between day 1 and month 1 as assessed by the resolution of the fever if present initially, by a 50% decrease or a normalization of the C-reactive protein and of the first hour ES
Measured: Day 1, 1 Month
Secondary outcomes (7)
Number, severity and type of adverse events over 12 months
Measured: Over 12 Months
Proportion of patients reaching 50%, 70% and 100% improvement of JIA activity according to Giannini's core-set criteria at each visit (day 15, month 1 to 6, month 9 and month 12)
Measured: Day 15, Month 1 to 6, Month 9 and Month 12
Proportion of patients in whom the daily dose of corticosteroids can be reduced to less than 0.3 mg/kg (less than 10 mg in patients over 34 kg) at month 6
Measured: Month 6
Proportion of patients with a normalization of the glycosylated ferritin / ferritin ratio (if lower than 1/4 initially) after 1, 2 and 6 months
Measured: 1 Month, Month 2, Month 6
Variation of cytokine expression by PBMC between Day 1 and Month 1 and Month 6
Measured: Day 1, Month 1, Month 6
Antibody response at month 1 and month 6 to Pneumo 23® immunization: immunization on day 1 against Streptococcus pneumoniae
Measured: Month 1, Month 6
Pharmacokinetic study at month 2 and month 6
Measured: Month 2, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study start11 May 2006
- Primary completion10 Jun 2008
- Study completion10 Jun 2008
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 Systemic-Onset Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre Quartier-dit-Maire, MD, Principal investigator, Pediatric Immuno-Hematology and Rheumatology Unit, Necker-Enfants Malades Hospital, 149 rue de Sevre, 75015 Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339157
- Sponsor's protocol ID
- C05-40
- Status last verified
- Jul 2010
- First submitted
- 16 Jun 2006
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Quartier P, Allantaz F, Cimaz R, Pillet P, Messiaen C, Bardin C, Bossuyt X, Boutten A, Bienvenu J, Duquesne A, Richer O, Chaussabel D, Mogenet A, Banchereau J, Treluyer JM, Landais P, Pascual V. A multicentre, randomised, double-blind, placebo-controlled trial with the interleukin-1 receptor antagonist anakinra in patients with systemic-onset juvenile idiopathic arthritis (ANAJIS trial). Ann Rheum Dis. 2011 May;70(5):747-54. doi: 10.1136/ard.2010.134254. Epub 2010 Dec 20.
PubMed 21173013
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANAkinra in Severe Juvenile Idiopathic Arthritis of Systemic Onset (ANAJIS)
- ClinicalTrials.gov ID
- NCT00339157
- Acronym / sponsor ID
- C05-40
- Keywords
- IDIOPATHIC JUVENILE ARTHRITIS, PEDIATRICS, ORPHAN DISEASE, INTERLEUKIN - 1, RECEPTORS , INTERLEUKINS, ANTAGONISTS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 11 May 2006 (actual)
- Primary completion
- 10 Jun 2008 (actual)
- Study completion
- 10 Jun 2008 (actual)
- First posted
- 20 Jun 2006 (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.
- Main objective: To test the efficacy of anakinra treatment in children or young adults with corticosteroid-resistant or -dependent Systemic-Onset Juvenile Idiopathic Arthritis (SO-JIA)
- Design: Double blind, randomized trial testing the efficacy of one month Anakinra treatment versus placebo (2 groups of 12 patients each). All the patients will be treated with anakinra during the following 11 months and the dose of corticosteroids will be gradually tapered (= descriptive part of the trial to assess the tolerance and efficacy over 12 months).
- Hypothesis: 70% significant improvement after 1 month in Anakinra-treated patients versus no more than 10% in the placebo group.
- Main inclusion criteria : diagnosis of SO-JIA (Durban consensus conference criteria), age: 2 to 20 years at inclusion, active, corticosteroid-resistant or -dependent disease, no previous IL-1ra treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teatment with ANAKINRA (2 mg/kg SC daily, maximum 100 mg) | Active comparator | Drug: Anakinra, Biological: Pneumo23Anakinra is injected subcutaneously once a day , for a dosage of 2 mg/kg per day with a maximum of 100 mg per day. The dose should be administered at approximately the same time every day. The treatment should be administered with no interruption during the whole study period. |
| Placebo treatment | Placebo comparator | Biological: Pneumo23, Other: PlaceboPlacebo is injected subcutaneously once a day using the same volume as the anakina treatment (dosage of 2 mg/kg per day of anakinra with a maximum of 100 mg per day). The dose should be administered at approximately the same time every day. The placebo treatment should be administered with no interruption during the whole study period. |
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- SO-JIA (Edmonton's revision of Durban's consensus conference criteria)
- Age: at least 2 years and less than 20 years at treatment initiation
- Disease duration of at least 6 months
- Failure of corticosteroid treatment or requirement for corticosteroid treatment at a daily dose equal to or over 0.3 mg/kg (10 mg in patients whose weight is over 34 kg)
- Active and severe systemic symptoms and/or arthritis as assessed by an experienced pediatric Rheumatologists, with at least 3 of the following criteria when assessing Giannini's core-set items: 1) physician global assessment of disease activity of at least 20/100; 2) parent/patient assessment of disease effect on overall well-being of at least 20/100; 3) functional disability with a Children Health Assessment Questionnaire (CHAQ, Ref [9]) score equal to or higher than 0.375/3; 4) 2 joints or more with active arthritis 5) 2 joints or more with non-irreversible limited range of motion (irreversible limited range of motion will be defined by radiological evidence of irreversible joint damage and ankylosis) 6) erythrocyte sedimentation rate (ESR) equal to or higher than 20.
Key exclusion criteria (8 listed)
- Previous treatment with IL-1Ra
- intra-articular injection or change in the doses of non-steroidal anti-inflammatory drugs and corticosteroids in the 4 weeks preceding the initiation of anakinra treatment
- Treatment with another immunosuppressive or disease-modifying drugs that could not be stopped before inclusion (for a duration depending on the drug pharmacokinetic properties)
- Contra-indication to the use of anakinra including ongoing active infection or allergy to E Coli's derivate or other components of the drug
- Previous history of malignancy or heart insufficiency
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 |
|---|---|---|
| Anakinra | Drug | Teatment with ANAKINRA (2 mg/kg SC daily, maximum 100 mg) |
| Pneumo23 | Biological | Placebo treatment, Teatment with ANAKINRA (2 mg/kg SC daily, maximum 100 mg) |
| Placebo | Other | Placebo treatment |
Primary outcome
30% improvement of JIA activity after 1 month compared to day 1 according to Giannini's core-set criteria, ie 30% improvement of at least 3 of the 6 items and no more than one item worsened by 30% or more.
Time frame: Day 1, 1 Month
Number of active arthritis
Time frame: Day 1, 1 Month
Number of joints with limitation of motion
Time frame: Day 1, 1 Month
Physician assessment of disease activity
Time frame: Day 1, 1 Month
Parent or patient's assessment of disease activity
Time frame: Day 1, 1 Month
Childhood health assessment questionnaire
Time frame: Day 1, 1 Month
First hour ESR)
Time frame: First hour
Improvement of systemic symptoms between day 1 and month 1 as assessed by the resolution of the fever if present initially, by a 50% decrease or a normalization of the C-reactive protein and of the first hour ES
Time frame: Day 1, 1 Month
7 secondary outcomes
Number, severity and type of adverse events over 12 months
Time frame: Over 12 Months
Proportion of patients reaching 50%, 70% and 100% improvement of JIA activity according to Giannini's core-set criteria at each visit (day 15, month 1 to 6, month 9 and month 12)
Time frame: Day 15, Month 1 to 6, Month 9 and Month 12
Proportion of patients in whom the daily dose of corticosteroids can be reduced to less than 0.3 mg/kg (less than 10 mg in patients over 34 kg) at month 6
Time frame: Month 6
Proportion of patients with a normalization of the glycosylated ferritin / ferritin ratio (if lower than 1/4 initially) after 1, 2 and 6 months
Time frame: 1 Month, Month 2, Month 6
Variation of cytokine expression by PBMC between Day 1 and Month 1 and Month 6
Time frame: Day 1, Month 1, Month 6
Antibody response at month 1 and month 6 to Pneumo 23® immunization: immunization on day 1 against Streptococcus pneumoniae
Time frame: Month 1, Month 6
Pharmacokinetic study at month 2 and month 6
Time frame: Month 2, Month 6
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 9 Jul 2026.
- Results publication: PubMed 21173013Quartier P, Allantaz F, Cimaz R, Pillet P, Messiaen C, Bardin C, Bossuyt X, Boutten A, Bienvenu J, Duquesne A, Richer O, Chaussabel D, Mogenet A, Banchereau J, Treluyer JM, Landais P, Pascual V. A multicentre, randomised, double-blind, placebo-controlled trial with the interleukin-1 receptor antagonist anakinra in patients with systemic-onset juvenile idiopathic arthritis (ANAJIS trial). Ann Rheum Dis. 2011 May;70(5):747-54. doi: 10.1136/ard.2010.134254. Epub 2010 Dec 20.
- information online from the French Institut National de la Sante Et de la Recherche MedicaleLink provided by the sponsor.
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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.
Pierre Quartier-dit-Maire, MD principal investigator
Pediatric Immuno-Hematology and Rheumatology Unit, Necker-Enfants Malades Hospital, 149 rue de Sevre, 75015 Paris, France
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anakinra and Pneumo23 in people with Systemic-Onset Juvenile Idiopathic Arthritis, run by Institut National de la Santé Et de la Recherche Médicale, France at 6 sites 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 10 inclusion and 8 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
30% improvement of JIA activity after 1 month compared to day 1 according to Giannini's core-set criteria, ie 30% improvement of at least 3 of the 6 items and no more than one item worsened by 30% or more. (time frame: Day 1, 1 Month). The study lists 8 primary outcomes in all. 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 NCT00339157, 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 9 Jul 2026.