Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT00339157 |
Date of registration:
|
16/06/2006 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITIS
|
Scientific title:
|
ANAkinra in Severe Juvenile Idiopathic Arthritis of Systemic Onset (ANAJIS) |
Date of first enrolment:
|
June 2006 |
Target sample size:
|
24 |
Recruitment status: |
Completed |
URL:
|
http://clinicaltrials.gov/show/NCT00339157 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
Phase:
|
Phase 2/Phase 3
|
|
Countries of recruitment
|
France
| | | | | | | |
Contacts
|
Name:
|
Pierre Quartier-dit-Maire, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Pediatric Immuno-Hematology and Rheumatology Unit, Necker-Enfants Malades Hospital, 149 rue de Sevre, 75015 Paris, France |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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
Age minimum:
2 Years
Age maximum:
20 Years
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Systemic-Onset Juvenile Idiopathic Arthritis
|
Intervention(s)
|
Drug: Anakinra
|
Biological: Pneumo23
|
Primary Outcome(s)
|
Number of active arthritis
|
Physician assessment of disease activity
|
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
|
Number of joints with limitation of motion
|
Parent or patient's assessment of disease activity
|
Childhood health assessment questionnaire
|
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.
|
First hour ESR)
|
Secondary Outcome(s)
|
Number, severity and type of adverse events 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)
|
Antibody response at month 1 and month 6 to Pneumo 23® immunization: immunization on day 1 against Streptococcus pneumoniae
|
Variation of cytokine expression by PBMC between Day 1 and Month 1 and 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
|
Pharmacokinetic study at month 2 and month 6
|
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
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|