Diagnostic evaluation of profound suppression of synovitis in juvenile idiopathic polyarticular arthritis: A comparison of imaging using Xiralite and power-doppler sonography with clinical measures in patients starting treatment with TNF-Blockers or DMARDs.
- Conditions
- MedDRA - juvenile idiopathic arthritisM08Juvenile arthritis
- Registration Number
- DRKS00011579
- Lead Sponsor
- Asklepios Klinik Sankt AugustinZentrum für Kinder-und Jugendmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 37
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).
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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<br>as after 3 months of treatment) for clinical response to therapy with either classical DMARD<br>or biologics (at 6 months of treatment).<br>To establish whether B-mode ultrasonography, Power Doppler sonography and Xiralite<br>imaging are applicable techniques in detecting subclinical arthritis (i.e. detection of<br>inflammation at a joint without clinical signs of activity) or residual disease.<br>To demonstrate evidence of joint protection by biologics (TNF-inhibitors) and conventional<br>DMARD (methotrexate, sulfasalazine).