Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 May 2025
• Main ID: NCT01500551
• Date of registration: 22/12/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis
• Scientific title: A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)
• Date of first enrolment: March 18, 2013
• Target sample size: 302
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01500551
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

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

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteria
for the qualifying/index study and in the opinion of the investigator have
sufficient evidence of JIA disease activity to warrant use of tofacitinib as a
DMARD. Subjects turning 18 years of age during participation in the qualifying/index
study or subsequently will be eligible for participation in this study.

- The subject has discontinued disallowed concomitant medications for the required
time prior to the first dose of study drug, as defined in Appendix 1, and is taking
only those concomitant medications in doses and frequency allowed by the protocol.

- Fertile male subjects and female subjects of childbearing potential who are, in the
opinion of the investigator, sexually active and at risk for pregnancy with their
partner(s) must be using a highly effective method of contraception as outlined in
this protocol throughout the study and for at least 28 days after the last dose of
study medication.

- Subjects must have previously completed participation in a qualifying study of
tofacitinib for the treatment of JIA. Subjects who have required earlier
discontinuation of treatment in a qualifying study for reasons other than
tofacitinib related serious adverse events may be eligible.

Exclusion Criteria:

- persistent oligoarthritis, and undifferentiated JIA.

- Infections:

1. Chronic infections.

2. Any infection requiring hospitalization, parenteral antimicrobial therapy or
judged to be opportunistic by the investigator within the 3 months prior to the
first dose of study drug.

3. Any treated infections within 2 weeks of baseline visit.

4. A subject known to be infected with human immunodeficiency virus (HIV),
hepatitis B or hepatitis C virus.

5. History of infected joint prosthesis with prosthesis still in situ.

- History of recurrent (more than one episode) herpes zoster or disseminated (a single
episode) herpes zoster or disseminated (a single episode) herpes simplex.


Age minimum: 2 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Juvenile Idiopathic Arthritis

Intervention(s)

Drug: Tofacitinib

Primary Outcome(s)

Standard laboratory safety data and adverse event (AE) reports. Body weight, height and Tanner Stages will collected to assess growth and physical development. [Time Frame: up to 8 years]

Secondary Outcome(s)

Index of inflammation (C-reactive protein [CRP] and Erythrocyte Sedimentation Rate [ESR]) at each visit. [Time Frame: up to 8 years]

JIA American College of Rheumatology (ACR) response and occurrence of JIA ACR disease flare at each visit. [Time Frame: up to 8 years]

In subjects with Enthesitis Related Arthritis (ERA): Change from baseline in the Tender Entheseal Assessment, Modified Schober's Test, Overall Back Pain and Nocturnal Back Pain responses at various visits. [Time Frame: up to 8 years]

Number of joints with active arthritis at each visit. [Time Frame: up to 8 years]

Parent's Assessment of Physical Function (Childhood Health Assessment Questionnaire [CHAQ]Disability Index)at each visit. [Time Frame: up to 8 years]

Parent's Global Assessment of Overall Wellbeing (Childhood Health Assessment Questionnaire [CHAQ] subsection, Visual Analog Scale [VAS])at each visit. [Time Frame: up to 8 years]

Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS) 27- CRP and JADAS 27-ESR, and occurrence of JADAS minimum disease activity and inactive disease at each visit. [Time Frame: up to 8 years]

Number of joints with limitation of motion at each visit. [Time Frame: up to 8 years]

Eligibility of tapering defined per protocol for corticosteroids [Time Frame: up to 8 years]

Eligibility of tapering defined per protocol for leflunomide [Time Frame: Up to 8 years]

Eligibility of tapering defined per protocol for methotrexate [Time Frame: up to 8 years]

Eligibility of tapering defined per protocol for tofacitinib [Time Frame: Up to 8 years]

In subjects with sJIA: "Absence of Fever", defined as absence of fever due to sJIA in the week preceding the assessment at each visit. [Time Frame: up to 8 years]

JIA ACR Clinical Inactive Disease status and Clinical Remission on Medication at each visit. [Time Frame: up to 8 years]

Physician global evaluation of disease activity at each visit. [Time Frame: up to 8 years]

In subjects with psoriatic arthritis (PsA): Change from baseline in body surface area (BSA) affected by psoriasis and Physician's Global Assessment (PGA) of psoriasis) at various visits. [Time Frame: up to 8 years]

Parent's Assessment of Child's Arthritis Pain (Childhood Health Assessment Questionnaire [CHAQ] Discomfort Index, Visual Analog Scale [VAS])at each visit. [Time Frame: up to 8 years]

Secondary ID(s)

JIA

2023-509651-14-00

A3921145

Source(s) of Monetary Support

Please refer to primary and secondary sponsors