A Long-Term, Open-Label, Study for Treatment of JIA
- Conditions
- JUVENILE IDIOPATHIC ARTHRITIS (JIA)MedDRA version: 23.1Level: PTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2011-004915-22-NL
- Lead Sponsor
- Pfizer Inc, 235 East 42nd Street, New York, New York 10017
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 340
Subjects eligibility should be reviewed and documented by an appropriately investigator before subjects are included in the study. All subjects must meet Inclusion Criteria 1-11 to be eligible for enrollment into the study: 1) 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. 2) 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 frequencies allowed by the protocol. 3) 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. 4) 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. 5) For subjects receiving methotrexate (MTX) treatment, MTX may be administered either orally or parenterally at doses not to exceed 25mg/week or 20 mg/m2/week, whichever is lower. Subjects taking methotrexate must be taking folic acid or folinic acid in accordance with local standards. 6)For subjects receiving an oral glucocorticoid, glucocorticoids may be administered at a maximum dose of 0.20 mg/kg/day or 10 mg/day, prednisone or equivalent, whichever is lower. 7)For subjects receiving leflunomide treatment, leflunomide may be administered according to the following dosing scheme:10 mg every other day for subjects patients weighing less than 20 kg; 10 mg every day for subjects weighing between 20 and 40 kg,; 20 mg every day for subjects weighing over 40 kg; Or as according to local standards. 8)For subjects receiving sulfasalazine, chloroquine, or hydroxychloroquine treatment, these medications may be administered according to local standards. 9)Evidence of a personally signed and dated informed consent document with assent as appropriate indicating that the subject (or a legally acceptable representative/ parent(s)/legal guardian) has been informed of all pertinent aspects of the study. 10)Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. 11)Subjects for whom, in the Investigator’s opinion, treatment with tofacitinib is considered clinically appropriate while also taking into consideration currently available therapies and prior response to these therapies. Subjects who enroll outside the 14 day window of the EOS Visit of their qualifying/index study must also meet Inclusion Criterion 12 to be eligible for enrollment into the study: 12) No evidence of active tuberculosis (TB) or inadequately treated tuberculosis (TB) infection (active or latent) as evidenced by all of the following: a) A negative QuantiFERONÒ-TB Gold In-Tube test4 performed within the 3 m
Subjects presenting with any of the following will not be included in the study: For subjects who enroll outside the 14 day window of the EOS Visit of their qualifying/index study (Exclusion 1-3):
1) 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. 2) Estimated glomerular filtration rate [GFR] <40 mL/min/1.73 m2 calculated using Bedside Schwartz formula (Appendix 5) at the Screening Visit. 3) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ³1.5 times the upper limit of normal or any other clinically significant laboratory abnormality. For all subjects: 4) Persistent oligoarthritis, and undifferentiated JIA. 5) Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease. 6) History of any other rheumatic autoimmune disease, other than Sjogren’s syndrome. 7) History or current symptoms suggestive of any lymphoproliferative disorder, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease. 8 ) Infections: a) Chronic infections. b) Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 6 months prior to the first dose of study drug: c) Any treated infections within 2 weeks of baseline visit. (excluding those treated with topicals only) d) A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.e.History of infected joint prosthesis with prosthesis still in situ. 9) History of recurrent (more than one episode) herpes zoster or a single episode of disseminated herpes zoster or a single episode of disseminated (both oral and gential lesions simutaneously, or widespread lesions not contaminaed to oral or gential regions alone) herpes simplex. 10) Previously failed treatment with another JAK inhibitor, such as baricitinib. 11) Subjects taking potent and moderate cytochrome P450 3A4 (CYP3A4) inhibitors (Appendix 6). 12) Subjects taking potent and moderate CYP3A4 inducers (Appendix 6).13) 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. 14) Any prior treatment with non B cell-specific lymphocyte depleting agents/therapies [eg. almetuzumab (CAMPATHÒ), 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. 15) Pregnant or nursing females are excluded. 16) Intramuscular or intravenous corticosteroids in the 4 weeks preceding first dose of study medication (oral corticosteriods permitted as per inlcusion criterion). 17) Subjects who have been vaccinated with live or attenuated
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method