STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS (STARS)
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|ClinicalTrials.gov Identifier: NCT03728478|
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : August 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Oligoarthritis, Juvenile Polyarthritis, Juvenile, Rheumatoid Factor Negative||Drug: Etanercept Drug: Methotrexate Drug: Intra-articular corticosteroid injections||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
This is a a 12-month open label, randomised, actively controlled, multi-centre, prospective, superiority trial of two different treatment strategies (Step-down versus Step-up).
After signature of informed consent/assent patients will be randomized into two therapeutic arms: "Step-up" or "Step-down". Patients in the Step-up arm will be treated according to a conventional strategy based on treatment escalation and driven by the treat-to-target strategy. Patients in the Step-Down arm will be treated with an early, combined, aggressive therapy for 6 months.
After the conclusion of the 12-month observation period of the trial, patients will be followed for up to 5 years for the evaluation of disease course, medication requirements, adverse events, and long-term disease-related morbidity.
|Masking:||None (Open Label)|
|Official Title:||Comparison of STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS|
|Actual Study Start Date :||May 29, 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
No Intervention: Treatment arm 1: Step-up
JIA patients managed with a Treat-To-Target strategy (T2T)
Experimental: Treatment arm 2: Step-down
JIA patients treated with an early combined therapy
Patients will receive etanercept subcutaneously at a dose of 0.8 mg/kg weekly (up to a maximum dose of 50 mg weekly).
Methotrexate will be administered subcutaneously, in a single weekly dose of 15 mg/m2 (max 20 mg).
Drug: Intra-articular corticosteroid injections
Triamcinolone hexacetonide and methylprednisolone acetate doses depend on the affected joint.
- Clinical remission on or off medication at 12 months [ Time Frame: 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.
- Inactive disease [ Time Frame: 12 months ]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 to inactive disease as per JADAS/JIA ACR criteria [ Time Frame: 12 months ]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 to JADAS/JIA ACR clinical remission [ Time Frame: 12 months ]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 spent in JADAS/JIA ACR inactive disease [ Time Frame: 12 months ]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.
- Cumulative level of disease activity throughout the study period [ Time Frame: 12 months ]The area under the curve (AUC) of the JADAS10 score assessed at every study visit and the AUC of the parent version of the JADAS (parJADAS) assessed monthly will be recorded and compared between the 2 arms.
- Time spent on therapy [ Time Frame: 12 months ]The cumulative time on therapy will be calculated as the time difference (in days) between the date of the visit at which the patient will start a systemic medication (synthetic or biologic DMARDs or steroids) until the date at which he/she will be observed to no longer be in treatment with a systemic medication, or completed the study. We assume that if a patient does not receive medications at 2 consecutive visits, the patient had not received medications all days between these visits. Patients initiating a systemic treatment at the final visit of the study will contribute a single day of time in therapy. The mean percentage of time spent on therapy per patient will be recorded and compared between the 2 arms.
- Rate of flares [ Time Frame: 12 months ]The rate of patients who develop flare, defined as the recurrence of active disease after attaining inactive disease at last visit according JADAS or JIA ACR definition, and the number of flares and the time to flare per patient will be recorded and compared. Notably, all patients prescribed intra-articular injections, synthetic or biologic DMARDs or systemic steroids will be considered as flare independently from JADAS or ACR criteria.
- Rate of uveitis onset [ Time Frame: 12 months ]The rate of patients who develop uveitis according to the Standardized Uveitis Nomenclature (SUN) will be recorded and compared between the 2 arms. The rate of patients requiring systemic medications for treatment of uveitis will be also recorded and compared between the 2 arms. However, these patients will be excluded from the study and followed for safety only.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728478
|Contact: Alessandro Consolaro, MD, PhDfirstname.lastname@example.org|
|Contact: Marta Mazzoni, MD,||email@example.com|
|IRCCS Istituto Giannina Gaslini||Recruiting|
|Genova, GE, Italy, 16147|
|Contact: Alessandro Consolaro, MD +39 01056362729 firstname.lastname@example.org|