A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)
- Conditions
- 10003816joint inflammationJuvenile arthritis10023213
- Registration Number
- NL-OMON52164
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 2
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
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) *1.5 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 fi
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary<br /><br>* Standard laboratory safety data and adverse event (AE) reports. Body weight,<br /><br>height and Tanner stages will be collected to assess growth and physical<br /><br>development.</p><br>
- Secondary Outcome Measures
Name Time Method