Health TrialsbyHealthPanel

STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS

ConditionsOligoarthritis, JuvenilePolyarthritis, Juvenile, Rheumatoid Factor Negative
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-17
SponsorIstituto Giannina Gaslini

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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 medical judgment of the study investigator and / or an infectious disease specialist.

Suspected extrapulmonary TB infection

Patients at high risk of contracting TB, such as close contact with individual with active or latent TB

Trial design

Design model

Parallel

Treatments tested in this trial

  • Etanercept

    Drug

    Patients will receive etanercept subcutaneously at a dose of 0.8 mg/kg weekly (up to a maximum dose of 50 mg weekly).

  • Methotrexate

    Drug

    Methotrexate will be administered subcutaneously, in a single weekly dose of 15 mg/m2 (max 20 mg).

  • Intra-articular corticosteroid injections

    Drug

    Triamcinolone hexacetonide and methylprednisolone acetate doses depend on the affected joint.

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Treatment arm 1: Step-upNo intervention 0 interventions
Group B: Treatment arm 2: Step-downExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Clinical remission on or off medication at 12 months

The effectiveness of the two therapeutic strategies will be compared by assessing the frequency of clinical remission (CR) at 12 months. CR is defined as the persistence of the JADAS state of ID for at least 6 months.

Time frame
12 months

Secondary outcomes

1

Inactive disease

The rate of patients who achieve the JADAS/JIA ACR state of ID at any single point in time throughout the study period will be compared between the 2 arms.

Time frame
12 months
2

Time to inactive disease as per JADAS/JIA ACR criteria

Time to achieve the state of JADAS/JIA ACR ID will be calculated as the time difference (in days) between the date of randomization and the date of the visit at which the patient will be observed to be in ID.

Time frame
12 months
3

Time to JADAS/JIA ACR clinical remission

Time to achieve the state of JADAS/JIA ACR ID will be calculated as the time difference (in days) between the date of randomization and the date of the visit at which the patient will be observed to be in clinical remission (i.e. persistent inactive disease for at least 6 months).

Time frame
12 months
4

Time spent in JADAS/JIA ACR inactive disease

The cumulative time spent in the JADAS/JIA ACR state of ID will be calculated as the time difference (in days) between the date of the first visit at which the patient will be observed to be in ID and the date at which he/she will be observed to be no longer in ID that is when the disease will flare (see later for definitions), or database closure for analysis purposes. We will assume that if a patient is found to be in ID at 2 consecutive visits, the patient had ID on all days between these visits. If a patient will be found to have ID at a particular visit, but lost the ID status at the subsequent visit, the patient will be considered to have been in ID until the recurrence of active disease. Patients found to be in ID only at the time of database closure will contribute a single day of ID. The time in inactive disease per patient will be recorded and compared between the 2 arms.

Time frame
12 months

Other outcomes

Sponsors and contacts

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Istituto Giannina Gaslini

Lead sponsor

Agenzia Italiana del Farmaco

Collaborator

Compagnia di San Paolo

Collaborator

Pfizer

Collaborator

Source ClinicalTrials.gov
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