A long-term, open label, study for treatment of JIA
- Conditions
- JUVENILE IDIOPATHIC ARTHRITIS (JIA)MedDRA version: 15.0Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 15.0Level: LLTClassification 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-IT
- Lead Sponsor
- PFIZER INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 24
Patients must meet all of the following inclusion criteria to be eligible for enrollment into the
study:
1. Pediatric patients 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 RA disease activity to warrant use of CP-690,550 as a DMARD. Patients
turning 18 years of age during participation in the qualifying/index study or
subsequently will be eligible for participation in this study.
2. The patient 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.
3. Fertility:
a. Sterile male, or non sterile male. If the patient is a non sterile male on
background medications (including DMARDs) that require male
contraceptive precautions according to the local drug label and is sexually
active with a female partner of child-bearing potential, he and his partner must
be practicing effective contraceptive measures.
b. Females of childbearing potential must be using a reliable means of
contraception (abstinence being a possible option) throughout the study and
and for at least one ovulatory cycle after CP-690,550 treatment is discontinued.
4. For patients receiving methotrexate (MTX) treatment, MTX may be administered
either orally or parenterally at doses up to the lesser of 20 mg/wk or 15 mg/m2/week.
5. For patients receiving leflunomide treatment, leflunomide may be administered
according to the following dosing scheme:
? 10 mg every other day for patients weighing less than 20 kg,
? 10 mg every day for patients weighing between 20 and 40 kg,
? 20 mg every day for patients weighing over 40 kg;
Or as according to local standards.
6. A negative QuantiFERON-TB Gold In-Tube test4 performed within the 3 months
prior to screening. A negative PPD test can be substituted for the
QuantiFERON-TB Gold In-Tube test only if the central laboratory is unable to
perform the test or cannot determine the results to be positive or negative and the
Pfizer medical monitor approves it, on a case-by-case basis.
7. Evidence of a personally signed and dated informed consent document with assent as
appropriate indicating that the patient (or a legally acceptable representative) has been
informed of all pertinent aspects of the study.
8. Patients who are willing and able to comply with all scheduled visits, treatment plan,
laboratory tests, and other study procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Systemic JIA with active systemic features, persistent oligoarthritis, and
undifferentiated JIA.
2. Blood dyscrasias, 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.
3. Estimated GFR <40 mL/min/1.73 m2 calculated using the Schwartz formula
(Appendix 4) at the Screening Visit.
4. Current or recent history of uncontrolled clinically significant renal, hepatic,
hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological
disease.
5. AST or ALT >/=1.5 times the upper limit of normal or any other clinically significant
laboratory abnormality.
For all patients:
6. History of any other rheumatic autoimmune disease.
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. Latent or active TB or any history of previous TB.
b. Chronic infections.
c. 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.
d. Any treated infections within 2 weeks.
e. A patient known to be infected with human immunodeficiency virus (HIV),
hepatitis B or hepatitis C virus.
f. History of infected joint prosthesis with prosthesis still in situ.
9. History of recurrent (more than one episode) herpes zoster or disseminated (a single
episode) herpes zoster or disseminated (a single episode) herpes simplex.
10. Patients taking potent and moderate cytochrome P450 3A4 (CYP3A4) inhibitors
(Appendix 5).
11. Patients taking potent and moderate CYP3A4 inducers (Appendix 5).
12. Participation in studies of investigational compounds (excluding qualifying/index
study with CP-690,550) within 4 weeks or 5 half-lives (whichever is longer) prior to
the first dose of study drug. Patients 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.
13. 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]. Patients 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.
14. Pregnant or nursing females; females of childbearing potential who are unwilling or
unable to use an acceptable method of contraception as outlined in this protocol
during the study and for least one ovulatory cycle after the last dose of study
medication.
15. Intramuscular or intravenous corticosteroids in the 4 weeks preceding first dose of
study medication.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to determine the long term safety and tolerability of<br>CP-690,550 for treatment of the signs and symptoms of JIA.;Secondary Objective: The secondary objective of this study is to evaluate the persistence of efficacy of<br>CP-690,550 for treatment of the signs and symptoms of JIA.<br>0901;Primary end point(s): Standard laboratory safety data and adverse event (AE) reports. Body weight, height<br>and Tanner Stages will collected to assess growth and physical development.;Timepoint(s) of evaluation of this end point: Primary endpoints consist of 4 items:<br>1) Standard Lab safety data<br>2) AE Assessment<br>3) body weight and height<br>4) Tanner stage
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ? Physician global evaluation of disease activity.<br>? Number of joints with active arthritis.<br>? Number of joints with limitation of motion.<br>? Index of inflammation (C-reactive protein [CRP]).<br>? Juvenile Arthritis Multidimensional Assessment Report (JAMAR).<br>? Parent’s or child evaluation of overall wellbeing (JAMAR Visual Analog Scale<br>[VAS] component).<br>? Functional ability (JAMAR).<br>? Health related quality of life (JAMAR).<br>? American College of Rheumatology (ACR) pediatric response and flare criteria.<br>? Inactive disease status parameters.;Timepoint(s) of evaluation of this end point: The secondary endpoints (section 2.2.2)will be assessed at Baseline, and Months 1,3,6,9 and 12. During study years 2-10 the assessments will be completed at 6 month intervals.