MedDRA - juvenile idiopathic arthritis M08
Conditions
Interventions
Group 1: Patients already started recently or planned to start a new treatment with either biologics (TNF-inhibitors or IL-6 inhibitor) or
conventional DMARDs (methotrexate or sulfasalazine) in additi
Sponsors
Asklepios Klinik Sankt AugustinZentrum für Kinder-und Jugendmedizin
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: I 1 Parents / legal guardian and patient are willing to participate in the evaluation and signed voluntarily the Informed Consent form. I 2 Patient and parents / legal guardian agree to comply with evaluation requirements and are able to be at the clinic for all required evaluation visits. I 3 Patient is at least 6 years old and has not reached his 18th birthday. I 4 Patient is planning to start treatment with a new disease-modifying antirheumatic drug (DMARD) or has started very recently (< 4 weeks) or Patient is planning to start treatment with a new biologic or has started very recently (< 2 weeks). I 5 In female patients in whom menarche has occurred willingness to use an adequate method of contraception. Adequate contraception can include abstinence if the investigator deems appropriate. I 6 Diagnosis of active JIA as determined by International League of Associations for Rheumatology (ILAR) criteria. The activity of the disease is judged with a minimum of 3 active joints of hands or fingers with either swelling not due to deformity or if no swelling is present with limiting of motion and pain or pain on movement. I 7 Patient have to meet all criteria for eligibility for treatment with the respective new drug (methotrexate, sulfasalazine, etanercept, adalimumab).
Exclusion criteria
Exclusion criteria: E 1 Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 30 days prior to evaluation baseline E 2 Any preceding diagnosis of malignancy E 3 Pregnant or breast feeding female E 4 Female not willing to use appropriate contraception or sexual abstinence. E 5 Active gastrointestinal disease (e.g., inflammatory bowel disease) E 6 Significant blood clotting defect E 7 Preceding diagnosis of tuberculosis or any opportunistic infection including herpes zoster at any time. E 8 Patient has a history of any chronic disease other than JIA, especially chronic renal disease, liver disease, hematological, gastrointestinal, pulmonary, cardiological or neurological disease, which in the opinion of the investigator leads to an unacceptable risk for the patient if he participates in the evaluation. E 9 Patient had a significant illness during a period of 4 weeks prior to the first administration of the dye other than JIA-related. E 10 Patient is abusing alcohol or drugs. E 11 Patient plans to increase dosing of oral corticosteroids within the evaluation period. E 12 Patient has previously been admitted to this evaluation. E 13 HIV infected E 14 Known past or current hepatitis infection E 15 Patient has a history of an expanding CNS neoplasm, active CNS infection, demyelinating disease, degenerative neurological disease or any progressive CNS disease. E 16 Patient has a poorly controlled diabetes. E 17 Received a live virus vaccine within 1 month prior to baseline E 18 Any concurrent medical condition which would, in the investigator's opinion, compromise the patient's ability to be adherent to the protocol. E 19 Patient has a history of or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. E 20 Any other inability to comply with the evaluation requirements. E 21 Patient is hypersensitive (allergic) to indocyanine green, sodium iodid or iodine. E 22 Patient suffers from thyroid hyperfunction or discrete beningn thyroid tumours or if parts of his thyroid are no longer under hormonal influences.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of clinical evaluation (pain, tenderness, swelling) including PedACR core set criteria and clinical remission criteria with imaging techniques using standardized ultrasonography (B-mode and Power Doppler) and Xiralite imaging in the assessment of joint synovitis in children with polyarticular juvenile idiopathic arthritis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of clinical improvement and improvement in the Imaging methods will be analyzed. Especially to answer the question whether changes in imaging are early predictors (as early as after 3 months of treatment) for clinical response to therapy with either classical DMARD or biologics (at 6 months of treatment). To establish whether B-mode ultrasonography, Power Doppler sonography and Xiralite imaging are applicable techniques in detecting subclinical arthritis (i.e. detection of inflammation at a joint without clinical signs of activity) or residual disease. To demonstrate evidence of joint protection by biologics (TNF-inhibitors) and conventional DMARD (methotrexate, sulfasalazine). | — |
Countries
Germany
Contacts
Public ContactGerd Horneff
Asklepios Klinik Sankt AugustinZentrum für Kinder-und Jugendmedizin
Outcome results
None listed