DRKS00011579CompletedNot Applicable
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. - -Xiralite-Observation
Asklepios Klinik Sankt AugustinZentrum für Kinder-und Jugendmedizin0 sites37 target enrollmentStarted: February 1, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 37
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 6 Years to 18 Years (—)
- Sex
- All
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)
- •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
- •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.
Investigators
Similar Trials
Not yet recruiting
Unknown
A systematic review of the suppressive effect of salacinol on postprandial sugar absorption.Adults whose fasting blood sugar level is within normal to edge range (excluding those under 18, pregnant women, and lactating women, who were not suffering from any diseases).JPRN-UMIN000053177FUJIFILM Corporation
Active, not recruiting
Not Applicable
Evaluation of the efficacy and suppression of the hypothalamic-pituitary-adrenal axis resulting in intrabursale single administration of cortisone in patients with calcific tendonitis of the rotator cuff '': randomized, controlled clinical trialcalcific tendonitis of the rotator cuffMedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2012-000866-40-ITISTITUTO ORTOPEDICO RIZZOLI
Completed
Not Applicable
Evaluating the Mental Status of the Effects of Specific Beverage Interventions on HumansJPRN-UMIN000048755Mibyou Life Science inc12
Completed
Phase 2
A verification study of suppressive effect on the postprandial blood glucose level by sugar-restricted dietHealthy subjects whose HbA1c level is 5.5% to 6.5%JPRN-UMIN000050020EZAKI GLICO Co., Ltd.10
Completed
Not Applicable
The verification for the suppressive effect of the test food consumption on the elevation of body surface temperatureHealthy Japanese subjectsJPRN-UMIN000047485ORTHOMEDICO Inc.66