A3921145 - A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)

Pfizer Inc.5 sites in 3 countries8 target enrollmentJune 17, 2024

Overview

Phase: Phase 2/3
Intervention: Not specified
Conditions: Not specified
Sponsor: Pfizer Inc.
Enrollment: 8
Locations: 5
Primary Endpoint: Standard laboratory safety data and adverse event (AE) reports. Body weight, height and Tanner Stages will be collected to assess growth and physical development.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to determine the long term safety and tolerability of tofacitinib for treatment of the signs and symptoms of JIA.

Registry

euclinicaltrials.eu

Start Date

June 17, 2024

End Date

TBD

Last Updated

last year

Investigators

Sponsor

Pfizer Inc.

Responsible Party

Principal Investigator

Clinical Medical Lead

Scientific

Pfizer Inc.

Eligibility Criteria

Inclusion Criteria

•JIA subjects aged 2 to <18 years who met entry criteria for qualifying/index study with sufficient JIA disease activity to use tofacitinib.
•Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
•Subjects for whom, in the Investigator's opinion, treatment with tofacitinib is considered clinically appropriate. Subjects who enroll outside the 14 day window of the EOS Visit of their qualifying/index study must also meet the below:
•No evidence of active tuberculosis (TB) or inadequately treated tuberculosis (TB) infection (active or latent) as defined in the protocol.
•Discontinuation of disallowed concomitant medications for the required time prior to first dose of study drug and only taking concomitant medications in allowable doses/frequencies.
•Fertile male 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 throughout the study and for at least 28 days after the last dose of study drug.
•Previously completed participation in a qualifying JIA study of tofacitinib.
•If receiving MTX, use of MTX orally or parenterally at doses not to exceed 25 mg/week or 20 mg/m2/week, whichever is lower. Must also take folic acid/folinic acid in accordance with local standards.
•If receiving an oral glucocorticoid, use of glucocorticoids at a max dose of 0.20 mg/kg/day or 10 mg/day, prednisone or equivalent, whichever is lower. For A3921165 subjects, a higher prednisone equivalent dose may be continued or started
•If receiving leflunomide treatment, use of leflunomide at the following doses: 10 mg every other day for subjects weighing 40 kg; Or as according to local standards.

Exclusion Criteria

•For subjects who enroll outside the 14 day window of the EOS Visit of their qualifying/index study (Exclusion 1-3): Blood dyscrasas, including: a. Hgb <10 g/dL or Hct <33%. b. WBC <3.0 x 109/L. c. Neutrophil count <1.2 x 109/L. d. Platelet count <100 x 109/L. e. Lymphocyte count of <0.75 x 109/L.
•Subjects taking potent and moderate cytochrome P450 3A4 (CYP3A4) inhibitors (Appendix 6).
•Subjects taking potent and moderate CYP3A4 inducers (Appendix 6).
•Participation in studies of investigational compounds (excluding qualifying/index study with tofacitinib) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug. Subjects cannot participate in studies of other investigational compounds at any time during their participation in this study. Exposure to investigational biologics should be discussed with the Pfizer Medical Monitor
•Any prior treatment with non B cell-specific lymphocyte depleting agents/therapies [eg, almetuzumab (CAMPATH®), alkylating agents (eg, cyclophosphamide or chlorambucil), total lymphoid irradiation, etc]. Subjects who have received rituximab or other selective B lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least 1 year prior to study baseline and have normal CD 19/20+ counts by FACS analysis.
•Pregnant or nursing females are excluded.
•Intramuscular or intravenous corticosteroids in the 4 weeks preceding first dose of study medication (oral cortico steroids permitted as per inclusion criterion).
•Subjects who have been vaccinated with live or attenuated vaccines within the 6 weeks prior to the first dose of study medication. All study participants should be up-to-date with respect to standard of care vaccinations (as defined by their country health ministry). (See Life Style Guidelines for further information regarding avoidance of household contacts who may be vaccinated).
•Use of prohibited prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
•Herbal supplements must be discontinued at least 4 weeks prior to the first dose of study medication.

Outcomes

Primary Outcomes

Standard laboratory safety data and adverse event (AE) reports. Body weight, height and Tanner Stages will be collected to assess growth and physical development.

Secondary Outcomes

Physician global evaluation of disease activity at each visit.
Number of joints with active arthritis at each visit.
Number of joints with limitation of motion at each visit.
Index of inflammation (C reactive protein [CRP]) and Erythrocyte Sedimentation Rate [ESR]) at each visit.
Childhood Health Assessment Questionnaire (CHAQ) at each visit.
Parent's Assessment of Physical Function (CHAQ Disability Index).
Parent's Assessment of Child's Arthritis Pain (CHAQ Discomfort Index, Visual Analog Scale [VAS]).
Parent's Assessment of Overall Wellbeing (CHAQ subsection Visual Analog Scale [VAS]).
JIA American College of Rheumatology (ACR) response and occurrence of JIA ACR disease flare at each visit.
JIA American Clinical Inactive Disease status and Clinical Remission of Medication at each visit and occurrence of JIA ACR disease flare at each visit after Month 3.
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.
Eligibility of tapering defined per protocol for corticosteroids, MTX/lefluomide, and tofacitinib.
In subjects with sJIA: "Absence of Fever", defined as absence of fever due to sJIA in the week preceding the assessment at each visit.
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 response at various visits.
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.