Treat to target in polyarticular juvenile idiopathic Arthritis
- Conditions
- MedDRA - 10023250 (Juvenile chronic polyarthritis)MedDRA - 10077210 (Extended oligoarthritis)M08.3Juvenile polyarthritis (seronegative)
- Registration Number
- DRKS00010764
- Lead Sponsor
- Asklepios Klinik Sankt Augustin Zentrum für Kinder-und Jugendmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 64
1) Parents / legal guardian and patient are willing to participate in the observation and signed voluntarily the informed consent form
2)Parents / legal guardian are willing to actively supervise storage and administration of observation drug.
3)Patient and parents / legal guardian agree to comply with observation requirements and are able to be at the clinic for all required observation visits.
4)Patient is at least 2 years old and has not reached his 17th birthday at baseline.
5)Patient is currently not treated with a disease-modifying antirheumatic drug (DMARD) and has not been treated before baseline.
6)IN FEMALE PATIENT IN WHOM MENARCHE HAS OCCURRED:Willingness to use an adequate method of contraception
7)Diagnosis of active polyarticular-JIA as determined by international League of Associations for Rheumatology (ILAR) criteria: rheumatoid factor positive polyarthritis , rheumatoid factor negative polyarthritis and extended oligoarthritis.
The activity of the disease is judged according to JADAS 10 score. JADAS 10 of > 5.4 is required for definition of active disease.
8)Early disease with a disease duration of up to 6 months. The onset of the disease is defined by the physician`sconfirmed presence of arthritis.
9)In patients treated with intraarticular corticosteroid injections during the 4 weeks preceding baseline, injected joints were counted as active for 28 days after injection irrespective of the clinical findings at baseline.
10)Patient is evaluated for active or latent TB infection according to routine practice at the centers. If applicable: Guidelines regarding the treatment of latent TB must be followed prior to the administration of rheumatic medication.
11)Patient have to meet all criteria for eligibility for treatment chosen by the investigator with methotrexate, etanercept, adalimumab, abatacept and tocilizumab according to SPC and local guidelines.
12)Either the subject or an available adult must be capable (according to the investigator`s judgment) of reconstituting and administering injections.
1)Patient has already had his17th birthday (diagnosis must be given before the age of 16 and disease duration must be less than 6 months)
2)Chronic or active infection or any major episode of infection requiring hospitalization or treatment with i.v antibiotics within 30 days prior baseline
3)Any preceding diagnosis of malignancy
4)Pregnant or breast feeding female. (n.a.=not applicable).
5)Female not willing to use appropriate contraception or sexual abstinence.
6)Active gastrointestinal disease (e.g., inflammatory bowel disease).
7)Significant blood clotting defect.
8)Preceding diagnosis of tuberculosis or any opportunistic infection including herpes zoster at any time.
9)Patient has a history of any chronic disease other than JAS, JRA / JIA, especially chronic renal disease, liver disease, hematological, gastrointestinal, pulmonary, cardiological or neurological disease, which in the opinion of the investigator may influence the efficacy or safety of the medication or which in the opinion of the investigator leads to an unacceptable risk for the patient if he participates in the observation.
10)Patient had a significant illness during a period of 4 weeks prior to the first administration of rheumatic medication other than JIA-related.
11)AST (SGOT) or ALT (SGPT) levels more than two times the upper level of normal, creatinine levels more than 1.5 mg/dl, or any other laboratory abnormality considered to be clinically significant within 28 days prior to baseline.
12)Received any investigational medication within 30 days prior to the first dose of rheumatic medication or scheduled to receive an investigational drug (other than the rheumatic medications) during the course of the observation.
13)Known HIV infection
14)Patient has been treated with any other investigational agent within 30 days or 5 half-lives of the agent, whichever is longer, prior to the baseline evaluation.
15)Patient has previously been admitted to this observation.
16)Known past or current hepatitis infection.
17)Patient has a history of an expanding CNS neoplasm, active CNS infection, demyelinating disease, degenerative neurological disease or any progressive CNS disease.
18)Patient has a poorly controlled diabetes.
19) Received a live virus vaccine within 1 month prior to baseline.
20)Any concurrent medical condition which would, in the investigator's opinion, compromise the patient's ability to tolerate the rheumatic drug or would make the patient unable to comply with the protocol.
21)Patient has a history of or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
22)Patient has a recent history of alcohol or drug abuse within the past 6 months that would interfere with ability to comply with protocol requirements.
23)Any other inability to comply with the observation requirements.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the clinical benefit (remission) in subjects with poly JIA treated following international recommendations.<br>-JADAS remission as defined by a JADAS10 = 1 compared to historical patients documented in the German BIKER registry <br>
- Secondary Outcome Measures
Name Time Method To assess the clinical benefit according to the JADAS definition of minimal disease activity (JADAS10 =3.8), the Ped ACR JIA 30%/50%/70%/90% and 100% improvement and inactive disease as defined according to the proposed criteria for inactive disease and remission of Wallace et al. (13) <br><br>To assess the long-term safety of routine medication in subjects with poly JIA.