AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA)

• Register: EUCTR
• Last refreshed on: 21 December 2021
• Main ID: EUCTR2011-004914-40-HU
• Date of registration: 17/05/2012
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017
• Public title: AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA)
• Scientific title: AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA)
• Date of first enrolment: 03/08/2012
• Target sample size: 24
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004914-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Czech Republic, Germany, Hungary, Italy, Mexico, Poland, Russian Federation, Serbia, Slovakia

Contacts

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc.

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
Patient eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before patients are included in the study. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Pediatric patients with JIA aged from 2 to less than 18 years with active JIA (extended oligoarthritis, polyarthritis rheumatoid factor positive or negative, psoriatic arthritis, enthesitis related arthritis), in 5 or more joints (using ACR definition of active joint) at the time of the first study drug administration.
1. The patient has discontinued prohibited concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 4 of the protocol, and is taking only those concomitant medications in doses and frequency allowed by the protocol.
2. Fertility:
a. Sterile male, or non sterile male. If the patient is a non sterile male receiving MTX treatment and is sexually active with a female partner of child bearing potential, he and his partner must be using an acceptable method of contraception during the study, and after therapy for the duration according to the local drug label.
b. Females of childbearing potential must be using an acceptable method of contraception (abstinence being a possible option) starting at least 14 days prior to the first dose of study drug and continuing for at least one ovulatory cycle after the last dose of study drug.
3. For patients receiving MTX treatment, minimum duration of therapy is 4 months and dose stable for at least 6 weeks prior to first dose of study drug. MTX may be administered either orally or parenterally at doses up to the lesser of 20 mg/wk or 15 mg/m2/week.
4. A negative QuantiFERON® TB Gold In Tube test 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.
5. Written informed consent for study participation obtained from parents or legal guardian, with assent as appropriate by the patient, depending on the level of the patient’s understanding.
6. 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

Exclusion criteria:
1.Systemic JIA, persistent oligoarthritis, undifferentiated arthritis. 2.Hgb<11 g/dL or Hct<33% (b) WBC <3.0 x 10 to the power of 9/L ; Neutrophil count<1.2 x 10 to the power of 9/L; Lymphocyte count<0.5x10 to the power of 9/L; Platelet count<100x 10 to the power of 9/L. 3. Estimated GFR <40 mL/min by Schwartz formula. 4.Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease. 5.AST or ALT=1.5XULN or other clinically significant laboratory abnormality. 6.History of any other rheumatic autoimmune disease. 7.History or current symptoms suggestive of any lymphoproliferative disorder (eg, Epstein Barr Virus related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease). 8 Infections: Latent or active TB or any history of previous TB; Chronic infections; Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 6months prior to the first dose of study drug; Any treated infections within 2weeks; Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus; History of infected joint prosthesis with prosthesis still in situ. 9History of recurrent or disseminated herpes zoster or disseminated herpes simplex. 10. Any condition possibly affecting drug absorption. 11.Potent and moderate CYP3A4 inhibitors. 12.Potent and moderate CYP3A4 inducers. 13.Following treatments are disallowed during this study and must be discontinued prior to first dose of study drug for at least:Anakinra and Etanercept, for 4weeks; Adalimumab, for 6weeks;Infliximab,for 8weeks; Golimumab, for 10weeks; Abatacept, tocilizumab and certolizumab pegol, for 12weeks; Auranofin (oral gold), aurothioglucose (injectable gold), aurothiomalate (injectable gold), for 8weeks; Sulfasalazine, d penicillamine, azathioprine, chloroquine, hydroxychloroquine, cyclosporine, tacrolimus, and staphylococcal protein A immuno absorbant pheresis columns, for 4weeks; 14.Following treatments are disallowed during this study and must be discontinued prior to first dose of study drug for at least: Leflunomide, for 8weeks. Alternatively, a washout procedure may be used; Ustekinumab, for 12weeks; Alefacept must be discontinued for 8weeks; UVB phototherapy for at least 2weeks. Psoralens +UVA phototherapy (PUVA) for 4 weeks.
15.Participation in studies of investigational compounds within 4 weeks or 5 half lives (whichever is longer) prior to the first dose of study drug or at any time during the study. 16.Any prior treatment with non B cell specific lymphocyte depleting agents/therapies [eg, almetuzuma, 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. 17.Pregnant or nursing females; females of childbearing potential unwilling or unable to use an acceptable method of contraception from at least 14 days prior to the first dose of study drug and for least one ovulatory cycle after the last dose. 18.Intramuscular, intravenous or intraarticular corticosteroids in the 4 weeks preceding first dose of study drug. 19.Vaccination wi

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

JUVENILE IDIOPATHIC ARTHRITIS
MedDRA version: 15.1 Level: LLT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 100000004859

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Code: CP-690,550-10
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tofacitinib
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550-10
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Product Code: CP-690,550-10
Pharmaceutical Form: Oral solution
INN or Proposed INN: Tofacitinib
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550-10
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)

Primary end point(s): - Oral clearance (CL/F) on Day 5.

- Safety and tolerability.

Secondary Objective: To evaluate taste acceptability of the oral formulation of CP 690,550 in pediatric patients with JIA.

Main Objective: To characterize the PK and safety of CP 690,550 following multiple oral doses in pediatric patients (from 2 to less than 18 years) with active JIA.

Timepoint(s) of evaluation of this end point: Baseline/Day 1 and Day 5

Secondary Outcome(s)

Secondary end point(s): - AUCt, Cmax, tmax and half life.

-Evaluation of taste acceptability of oral formulation.

Timepoint(s) of evaluation of this end point: Baseline/Day 1 and Day 5

Secondary ID(s)

A3921103

NCT01513902

2011-004914-40-PL

Source(s) of Monetary Support

Pfizer Inc.

Ethics review

Status: Approved
Approval date: 03/08/2012
Contact:

Results

• Results available: Yes
• Date Posted: 13/07/2016
• Date Completed: 04/12/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004914-40/results