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New treatment option for Oligoarthritis, Juvenile
Official title STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS
ClinicalTrials.gov ID: NCT03728478
What this study is testing
What is Etanercept?
Etanercept is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for oligoarthritis, juvenile.
Also referred to as ETN.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to compare the effectiveness of a conventional therapeutic regimen, based on treatment escalation (step-up strategy) and driven by the treat-to-target approach, with that of an early aggressive intervention based on the initial start of a combination of conventional and biological DMARDs (step-down strategy).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Each patient must meet all the following criteria in order to be enrolled in the trial:
- I. Newly-diagnosed and synthetic or biologic DMARD-naïve children (only treatment with 1 NSAID is allowed and no corticosteroid joint injections...
- i. Oligoarthritis ii. Rheumatoid factor negative polyarthritis
- II. Active arthritis
- III. Onset of JIA symptoms no more than 6 months before randomization
You likely can't join if
- I. Classification in one of the following JIA categories: systemic arthritis, RF-positive polyarthritis, psoriatic arthritis, enthesitis-related...
- Active TB or a history of incompletely treated TB
- PPD or QuantiFERON-TB positive patients (with no active disease) unless it is documented by a specialist that the patient has been adequately treated...
- Suspected extrapulmonary TB infection
- Patients at high risk of contracting TB, such as close contact with individual with active or latent TB IV. Previous treatment with any synthetic or...
- White blood cell (WBC) count \<3.50 x 103/mm3 (SI units: \<3.50 x 109/L) and neutrophils \< 1x109/L;
See the full eligibility criteria
- Each patient must meet all the following criteria in order to be enrolled in the trial:
- I. Newly-diagnosed and synthetic or biologic DMARD-naïve children (only treatment with 1 NSAID is allowed and no corticosteroid joint injections prior to randomization ) with a JIA classified according to the following...
- i. Oligoarthritis ii. Rheumatoid factor negative polyarthritis
- II. Active arthritis
- III. Onset of JIA symptoms no more than 6 months before randomization
- IV. Age 2 to 17 years at enrolment.
- V. Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial. If sexually active, they must agree to use highly effective contraceptive measures, throughout study participation...
- VI. Ability to comply with the entire study procedures, ability to communicate meaningfully with the investigational staff, competence to give written informed consent; to be applied to the parents and/or patients, as...
- VII. Duly executed, written, informed consent/assent obtained from the parents/patient.
- I. Classification in one of the following JIA categories: systemic arthritis, RF-positive polyarthritis, psoriatic arthritis, enthesitis-related arthritis, undifferentiated arthritis II. Patients who need systemic...
- Active TB or a history of incompletely treated TB
- PPD or QuantiFERON-TB positive patients (with no active disease) unless it is documented by a specialist that the patient has been adequately treated for TB and can start treatment with a biologic agent, based on the...
- Suspected extrapulmonary TB infection
- Patients at high risk of contracting TB, such as close contact with individual with active or latent TB IV. Previous treatment with any synthetic or biologic DMARD V. Any live attenuated vaccine within 4 weeks prior to...
- White blood cell (WBC) count \<3.50 x 103/mm3 (SI units: \<3.50 x 109/L) and neutrophils \< 1x109/L;
- Hemoglobin \< 8.5 g/dL (SI units: \<85 g/L);
- Platelet Count \< 125,0000/mm3 or ≥1,000,000/mm3 (SI units: \<125 x 109/L or ≥1,000 x 109/L
- Aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT) ≥ 2.0 x upper limit of normal (ULN).
The study team makes the final eligibility decision.
Where it's taking place
- Genova, GE, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Genova, GE, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.