A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA

• Register: ClinicalTrials.gov
• Last refreshed on: 22 April 2024
• Main ID: NCT03000439
• Date of registration: 09/11/2016
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
• Scientific title: EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS
• Date of first enrolment: May 10, 2018
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03000439
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Belgium, Brazil, Canada, Chile, China, Costa Rica, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Slovakia, South Africa, Spain, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- active sJIA disease according to ILAR criteria before screening and at baseline (Day
1);

- Treatment with stable doses of methotrexate (MTX) =25 mg/week or =20 mg/m2/week,
whichever is lower, is permitted;

- Treatment with a stable dose of oral prednisone =1 mg/kg/day up to a maximum of 30
mg/day, or equivalent, for at least 1 week before the first study drug dose is
permitted.

Exclusion Criteria:

- Previous juvenile idiopathic arthritis (JIA) treatment with tofacitinib.

- Current symptoms or findings of myocarditis, endocarditis or more than minimal
pericardial effusion associated with systemic juvenile idiopathic arthritis (sJIA).
Current symptoms or findings of more than minimal pleuritis with sJIA.

- Current infection or serious infection within 3 months of study enrollment.



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis Juvenile Idiopathic

Intervention(s)

Drug: In open-label phase: treatment with tofacitinib

Drug: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio

Primary Outcome(s)

Time to flare [Time Frame: Up to 82 weeks after randomization]

Secondary Outcome(s)

Achievement of a corticosteroid dose of 0.2 mg/kg/day or 10 mg/day (whichever is lower) at the end of the open label treatment period [Time Frame: 12 to 40 weeks]

Occurrence of inactive disease status and minimal disease activity clinical remission at every visit from Day 7 onward (JADAS 27) in the open label and double blind phase. [Time Frame: Up to 82 weeks after randomization.]

Achievement of corticosteroid tapering at the end of the open-label phase [Time Frame: 12 to 40 weeks]

Adapted sJIA ACR 30/50/70/90/100 response at every visit from Day 7 onward in the open label and double blind phase. [Time Frame: Up to 82 weeks after randomization]

Change from baseline in Child Health Questionnaire (CHQ) responses at the end of Part 1 and Part 2 of the open label phase, at randomization and every 3 months thereafter. [Time Frame: Up to 82 weeks after randomization.]

CRP = 10 mg/L at every visit of the open label phase. [Time Frame: 12 to 40 weeks]

Fever (Temp >38 Degrees Celsius) attributed to sJIA at Day 3, Day 7 and Day 14 of the open label phase. [Time Frame: Day 3, Day 7, Day 14]

"Absence of fever", defined as absence of fever due to sJIA in the week preceding the assessment at every visit from Day 7 onward in the open label and double blind phase. [Time Frame: Up to 82 weeks after randomization.]

Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS 27) at every visit from Day 7 onward in the open label and double blind phase. [Time Frame: Up to 82 weeks after randomization.]

Change from baseline in Child Health Assessment Questionnaire (CHAQ) at every visit from Day 7 onward in the open label and double blind phase. [Time Frame: Up to 82 weeks after randomization.]

Occurrence of inactive disease status and clinical remission at every visit from Day 7 onward (JIA ACR) in the open label and double blind phase. [Time Frame: Up to 82 weeks after randomization.]

Time to first Adapted JIA ACR 30 response in Part 1 of the open label phase. [Time Frame: 12 to 40 weeks]

Change from baseline in each JIA ACR core variable at every visit from Day 7 onward in the open label and double blind phase. [Time Frame: Up to 82 weeks after randomization.]

Occurrence of disease flare in double-blind phase [Time Frame: Up to 82 weeks after randomization]

Secondary ID(s)

A3921165

2017-002018-29

Source(s) of Monetary Support

Please refer to primary and secondary sponsors