Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT01513902
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2012-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1--800--718--1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 28 days after the last dose of study drug (Day 5)', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort I: 12 Years to <18 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter \\[mL\\] to 3 mL) for children weighing \\<40 kilogram (kg) or twice daily as oral tablets (5 milligram \\[mg\\]) for participants weighing greater than or equal to (\\>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.', 'otherNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort II: 6 Years to <12 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing \\<40 kg, oral tablets (5 mg) were used for participants weighing \\>=40 kg. Participants with a body weight of \\>=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).', 'otherNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort III: 2 Years to <6 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing \\<30 kg. Participants weighing \\>=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).', 'otherNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Apparent Oral Clearance (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: 12 Years to <18 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter \\[mL\\] to 3 mL) for children weighing \\<40 kilogram (kg) or twice daily as oral tablets (5 milligram \\[mg\\]) for participants weighing greater than or equal to (\\>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.'}, {'id': 'OG001', 'title': 'Cohort II: 6 Years to <12 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing \\<40 kg, oral tablets (5 mg) were used for participants weighing \\>=40 kg. Participants with a body weight of \\>=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}, {'id': 'OG002', 'title': 'Cohort III: 2 Years to <6 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing \\<30 kg. Participants weighing \\>=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '28.09', 'spread': '22', 'groupId': 'OG000'}, {'value': '25.48', 'spread': '40', 'groupId': 'OG001'}, {'value': '20.53', 'spread': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is also influenced by the fraction of the dose absorbed. Clearance was estimated by non compartmental analysis (NCA) of PK data. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCtau. AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval.', 'unitOfMeasure': 'liter per hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'number of participants analyzed (N)' signifies those participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) All Causalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: 12 Years to <18 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter \\[mL\\] to 3 mL) for children weighing \\<40 kilogram (kg) or twice daily as oral tablets (5 milligram \\[mg\\]) for participants weighing greater than or equal to (\\>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.'}, {'id': 'OG001', 'title': 'Cohort II: 6 Years to <12 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing \\<40 kg, oral tablets (5 mg) were used for participants weighing \\>=40 kg. Participants with a body weight of \\>=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}, {'id': 'OG002', 'title': 'Cohort III: 2 Years to <6 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing \\<30 kg. Participants weighing \\>=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after the last dose of study drug (Day 5)', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs included both serious and non-serious AEs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Test Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: 12 Years to <18 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter \\[mL\\] to 3 mL) for children weighing \\<40 kilogram (kg) or twice daily as oral tablets (5 milligram \\[mg\\]) for participants weighing greater than or equal to (\\>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.'}, {'id': 'OG001', 'title': 'Cohort II: 6 Years to <12 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing \\<40 kg, oral tablets (5 mg) were used for participants weighing \\>=40 kg. Participants with a body weight of \\>=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}, {'id': 'OG002', 'title': 'Cohort III: 2 Years to <6 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing \\<30 kg. Participants weighing \\>=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 5', 'description': 'Participants with laboratory test abnormalities of potential clinical concern without regard to baseline abnormality were reported. Criteria: Hematology(hemoglobin,hematocrit,red blood cell\\[RBC\\] count:\\<0.8\\*lower limit of normal \\[LLN\\], platelets:\\<0.5\\*LLN/greater than \\[\\>\\]1.75\\*upper limit of normal\\[ULN\\], white blood cell \\[WBC\\] count:\\<0.6\\*LLN\\>\\</0\\>1.5\\*ULN, lymphocytes, total neutrophils:\\<0.8\\*LLN or \\>1.2\\*ULN, basophils, eosinophil, monocytes:\\>1.2\\*ULN); Liver Function (total bilirubin: \\>1.5\\*ULN, aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:\\>3.0\\*ULN, total protein, albumin:\\<0.8\\*LLN or \\>1.2\\*ULN);Renal Function (blood urea nitrogen, creatinine:\\>1.3\\*ULN, uric acid:\\>1.2\\*ULN); Electrolytes (sodium:\\<0.95\\*LLN or \\>1.05\\*ULN,potassium,chloride,calcium,bicarbonate:\\<0.9\\*LLN or \\>1.1\\*ULN);Clinical chemistry (glucose \\<0.6\\*LLN or \\>1.5\\*ULN, creatine kinase:\\>3.0\\*ULN); Urinalysis (Urine WBC and RBC: greater than or equal to \\[\\>=\\] 6/High Power Field \\[HPF\\]).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: 12 Years to <18 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter \\[mL\\] to 3 mL) for children weighing \\<40 kilogram (kg) or twice daily as oral tablets (5 milligram \\[mg\\]) for participants weighing greater than or equal to (\\>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.'}, {'id': 'OG001', 'title': 'Cohort II: 6 Years to <12 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing \\<40 kg, oral tablets (5 mg) were used for participants weighing \\>=40 kg. Participants with a body weight of \\>=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}, {'id': 'OG002', 'title': 'Cohort III: 2 Years to <6 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing \\<30 kg. Participants weighing \\>=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 5', 'description': 'Criteria for vital signs of potentially clinical concern included supine/sitting pulse rate of \\<40 beats per minute (bpm) or \\>120 bpm, standing pulse rate of \\<40 bpm or \\>140 bpm, systolic blood pressure of \\>=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure \\<90 mmHg, diastolic blood pressure \\>=20 mmHg change from baseline and diastolic blood pressure \\<50 mm Hg.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: 12 Years to <18 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter \\[mL\\] to 3 mL) for children weighing \\<40 kilogram (kg) or twice daily as oral tablets (5 milligram \\[mg\\]) for participants weighing greater than or equal to (\\>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.'}, {'id': 'OG001', 'title': 'Cohort II: 6 Years to <12 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing \\<40 kg, oral tablets (5 mg) were used for participants weighing \\>=40 kg. Participants with a body weight of \\>=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}, {'id': 'OG002', 'title': 'Cohort III: 2 Years to <6 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing \\<30 kg. Participants weighing \\>=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '156.6', 'spread': '25', 'groupId': 'OG000'}, {'value': '118.8', 'spread': '27', 'groupId': 'OG001'}, {'value': '142.5', 'spread': '32', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: 12 Years to <18 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter \\[mL\\] to 3 mL) for children weighing \\<40 kilogram (kg) or twice daily as oral tablets (5 milligram \\[mg\\]) for participants weighing greater than or equal to (\\>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.'}, {'id': 'OG001', 'title': 'Cohort II: 6 Years to <12 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing \\<40 kg, oral tablets (5 mg) were used for participants weighing \\>=40 kg. Participants with a body weight of \\>=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}, {'id': 'OG002', 'title': 'Cohort III: 2 Years to <6 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing \\<30 kg. Participants weighing \\>=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '46.97', 'spread': '40', 'groupId': 'OG000'}, {'value': '41.67', 'spread': '29', 'groupId': 'OG001'}, {'value': '66.15', 'spread': '28', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: 12 Years to <18 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter \\[mL\\] to 3 mL) for children weighing \\<40 kilogram (kg) or twice daily as oral tablets (5 milligram \\[mg\\]) for participants weighing greater than or equal to (\\>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.'}, {'id': 'OG001', 'title': 'Cohort II: 6 Years to <12 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing \\<40 kg, oral tablets (5 mg) were used for participants weighing \\>=40 kg. Participants with a body weight of \\>=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}, {'id': 'OG002', 'title': 'Cohort III: 2 Years to <6 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing \\<30 kg. Participants weighing \\>=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.750', 'spread': '25', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '6.90'}, {'value': '1.00', 'spread': '27', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '2.05'}, {'value': '0.500', 'spread': '32', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '1.92'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vz/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: 12 Years to <18 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter \\[mL\\] to 3 mL) for children weighing \\<40 kilogram (kg) or twice daily as oral tablets (5 milligram \\[mg\\]) for participants weighing greater than or equal to (\\>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.'}, {'id': 'OG001', 'title': 'Cohort II: 6 Years to <12 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing \\<40 kg, oral tablets (5 mg) were used for participants weighing \\>=40 kg. Participants with a body weight of \\>=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}, {'id': 'OG002', 'title': 'Cohort III: 2 Years to <6 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing \\<30 kg. Participants weighing \\>=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '104.9', 'spread': '35', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '6.90'}, {'value': '71.0', 'spread': '40', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '2.05'}, {'value': '51.44', 'spread': '34', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '1.92'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.', 'unitOfMeasure': 'liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-Life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: 12 Years to <18 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter \\[mL\\] to 3 mL) for children weighing \\<40 kilogram (kg) or twice daily as oral tablets (5 milligram \\[mg\\]) for participants weighing greater than or equal to (\\>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.'}, {'id': 'OG001', 'title': 'Cohort II: 6 Years to <12 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing \\<40 kg, oral tablets (5 mg) were used for participants weighing \\>=40 kg. Participants with a body weight of \\>=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}, {'id': 'OG002', 'title': 'Cohort III: 2 Years to <6 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing \\<30 kg. Participants weighing \\>=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.616', 'spread': '0.454', 'groupId': 'OG000'}, {'value': '1.949', 'spread': '0.294', 'groupId': 'OG001'}, {'value': '1.771', 'spread': '0.406', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Taste Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I: 12 Years to <18 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter \\[mL\\] to 3 mL) for children weighing \\<40 kilogram (kg) or twice daily as oral tablets (5 milligram \\[mg\\]) for participants weighing greater than or equal to (\\>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.'}, {'id': 'OG001', 'title': 'Cohort II: 6 Years to <12 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing \\<40 kg, oral tablets (5 mg) were used for participants weighing \\>=40 kg. Participants with a body weight of \\>=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}, {'id': 'OG002', 'title': 'Cohort III: 2 Years to <6 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing \\<30 kg. Participants weighing \\>=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}], 'classes': [{'title': 'Day 1: Dislike very much', 'categories': [{'measurements': [{'value': '0', 'spread': '0.45350', 'groupId': 'OG000'}, {'value': '1', 'spread': '0.29396', 'groupId': 'OG001'}, {'value': '1', 'spread': '0.40634', 'groupId': 'OG002'}]}]}, {'title': 'Day 1: Dislike a little', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Day 1: Not sure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Day 1: Like a little', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Day 1: Like very much', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Day 5: Dislike very much', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 5: Dislike a little', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Day 5: Not sure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Day 5: Like a little', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Day 5: Like very much', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, Day 5', 'description': 'Participants were evaluated for taste assessment using a 5 categories questionnaire. Participants were asked to answer one of the following to describe the taste of oral solution of tofacitinib: Dislike very much, dislike a little, not sure, like a little, or like very much. The taste assessment was only performed for participants who received the oral solution. Number of participants within each category are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as all participants who had received at least 1 oral solution formulation of tofacitinib.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort I: 12 Years to <18 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter \\[mL\\] to 3 mL) for children weighing \\<40 kilogram (kg) or twice daily as oral tablets (5 milligram \\[mg\\]) for participants weighing greater than or equal to (\\>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.'}, {'id': 'FG001', 'title': 'Cohort II: 6 Years to <12 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing \\<40 kg, oral tablets (5 mg) were used for participants weighing \\>=40 kg. Participants with a body weight of \\>=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}, {'id': 'FG002', 'title': 'Cohort III: 2 Years to <6 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing \\<30 kg. Participants weighing \\>=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants aged 2 to less than (\\<)18 years with juvenile idiopathic arthritis (JIA) were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort I: 12 Years to <18 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter \\[mL\\] to 3 mL) for children weighing \\<40 kilogram (kg) or twice daily as oral tablets (5 milligram \\[mg\\]) for participants weighing greater than or equal to (\\>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.'}, {'id': 'BG001', 'title': 'Cohort II: 6 Years to <12 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing \\<40 kg, oral tablets (5 mg) were used for participants weighing \\>=40 kg. Participants with a body weight of \\>=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}, {'id': 'BG002', 'title': 'Cohort III: 2 Years to <6 Years', 'description': 'CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing \\<30 kg. Participants weighing \\>=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '9.4', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '4.0', 'spread': '1.0', 'groupId': 'BG002'}, {'value': '9.0', 'spread': '4.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety analysis population included all participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-24', 'studyFirstSubmitDate': '2012-01-17', 'resultsFirstSubmitDate': '2016-05-24', 'studyFirstSubmitQcDate': '2012-01-17', 'lastUpdatePostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-24', 'studyFirstPostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apparent Oral Clearance (CL/F)', 'timeFrame': 'Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is also influenced by the fraction of the dose absorbed. Clearance was estimated by non compartmental analysis (NCA) of PK data. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCtau. AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) All Causalities', 'timeFrame': 'Baseline up to 28 days after the last dose of study drug (Day 5)', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs included both serious and non-serious AEs.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities', 'timeFrame': 'Baseline up to Day 5', 'description': 'Participants with laboratory test abnormalities of potential clinical concern without regard to baseline abnormality were reported. Criteria: Hematology(hemoglobin,hematocrit,red blood cell\\[RBC\\] count:\\<0.8\\*lower limit of normal \\[LLN\\], platelets:\\<0.5\\*LLN/greater than \\[\\>\\]1.75\\*upper limit of normal\\[ULN\\], white blood cell \\[WBC\\] count:\\<0.6\\*LLN\\>\\</0\\>1.5\\*ULN, lymphocytes, total neutrophils:\\<0.8\\*LLN or \\>1.2\\*ULN, basophils, eosinophil, monocytes:\\>1.2\\*ULN); Liver Function (total bilirubin: \\>1.5\\*ULN, aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:\\>3.0\\*ULN, total protein, albumin:\\<0.8\\*LLN or \\>1.2\\*ULN);Renal Function (blood urea nitrogen, creatinine:\\>1.3\\*ULN, uric acid:\\>1.2\\*ULN); Electrolytes (sodium:\\<0.95\\*LLN or \\>1.05\\*ULN,potassium,chloride,calcium,bicarbonate:\\<0.9\\*LLN or \\>1.1\\*ULN);Clinical chemistry (glucose \\<0.6\\*LLN or \\>1.5\\*ULN, creatine kinase:\\>3.0\\*ULN); Urinalysis (Urine WBC and RBC: greater than or equal to \\[\\>=\\] 6/High Power Field \\[HPF\\]).'}, {'measure': 'Number of Participants With Clinically Significant Vital Signs Abnormalities', 'timeFrame': 'Baseline up to Day 5', 'description': 'Criteria for vital signs of potentially clinical concern included supine/sitting pulse rate of \\<40 beats per minute (bpm) or \\>120 bpm, standing pulse rate of \\<40 bpm or \\>140 bpm, systolic blood pressure of \\>=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure \\<90 mmHg, diastolic blood pressure \\>=20 mmHg change from baseline and diastolic blood pressure \\<50 mm Hg.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)', 'timeFrame': 'Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': 'Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose'}, {'measure': 'Apparent Volume of Distribution (Vz/F)', 'timeFrame': 'Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.'}, {'measure': 'Plasma Decay Half-Life (t1/2)', 'timeFrame': 'Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Taste Assessment', 'timeFrame': 'Day 1, Day 5', 'description': 'Participants were evaluated for taste assessment using a 5 categories questionnaire. Participants were asked to answer one of the following to describe the taste of oral solution of tofacitinib: Dislike very much, dislike a little, not sure, like a little, or like very much. The taste assessment was only performed for participants who received the oral solution. Number of participants within each category are reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arthritis', 'Pediatric', 'Tofacitinib', 'JIA'], 'conditions': ['Juvenile Idiopathic Arthritis']}, 'referencesModule': {'references': [{'pmid': '38298058', 'type': 'DERIVED', 'citation': 'Chang C, Vong C, Wang X, Hazra A, Diehl A, Nicholas T, Mukherjee A. Tofacitinib pharmacokinetics in children and adolescents with juvenile idiopathic arthritis. CPT Pharmacometrics Syst Pharmacol. 2024 Apr;13(4):599-611. doi: 10.1002/psp4.13104. Epub 2024 Jan 31.'}, {'pmid': '29282090', 'type': 'DERIVED', 'citation': 'Ruperto N, Brunner HI, Zuber Z, Tzaribachev N, Kingsbury DJ, Foeldvari I, Horneff G, Smolewska E, Vehe RK, Hazra A, Wang R, Mebus CA, Alvey C, Lamba M, Krishnaswami S, Stock TC, Wang M, Suehiro R, Martini A, Lovell DJ; Pediatric Rheumatology International Trials Organization (PRINTO); Pediatric Rheumatology Collaborative Study Group (PRCSG). Pharmacokinetic and safety profile of tofacitinib in children with polyarticular course juvenile idiopathic arthritis: results of a phase 1, open-label, multicenter study. Pediatr Rheumatol Online J. 2017 Dec 28;15(1):86. doi: 10.1186/s12969-017-0212-y.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921103&StudyName=Pharmacokinetics%20Of%20CP-690%2C550%20In%20Pediatric%20Patients%20With%20Juvenile%20Idiopathic%20Arthritis%20%28JIA%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Phase 1 study to describe pharmacokinetics of CP-690,550 in pediatric patients 2 to less than 18 years of age with Juvenile Idiopathic Rheumatoid Arthritis (JIA).', 'detailedDescription': 'This is an open-label, non-randomized, multi-center, oral CP-690,550, multiple-dose (twice daily for 5 days \\[except Day 5 when only morning dose will be given\\]) study in pediatric subjects with JIA aged from 2 to less than 18 years. Baseline visit will occur within 1 month of the completion of the Screening Visit. The study will consist of three cohorts based on the age of the subjects, Cohort 3: 2 to less than 6 years, Cohort 2: 6 to less than 12 years and Cohort 1: 12 to less than 18 years. In each cohort, at least 8 pediatric subjects with JIA will participate in the study ensuring a total number of at least 24 pediatric evaluable subjects completing the PK period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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 American College Rheumatology definition of active joint) at the time of the first study drug administration.\n2. For subjects 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 not to exceed 20 mg/wk or 15 mg/m2/week.\n3. 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.\n\nExclusion Criteria:\n\n1. Systemic JIA, persistent oligoarthritis, undifferentiated arthritis.\n2. Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease.\n3. History of any other rheumatic autoimmune disease.\n4. Infections:\n\n 1. Latent or active TB or any history of previous TB.\n 2. Chronic infections.\n 3. 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.\n 4. Any treated infections within 2 weeks of Baseline visit.\n 5. A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.\n 6. History of infected joint prosthesis with prosthesis still in situ.\n5. History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.\n6. The biologic agents and DMARDs are disallowed at any time during this study. If a subject needs to be treated with one of these agents, the subject should be discontinued from the study.\n7. Subjects who have been vaccinated with live or attenuated vaccines within the 6 weeks prior to the first dose of study medication or is to be vaccinated with these vaccines at any time during treatment or within 6 weeks following discontinuation of study drug.\n8. Subjects with a malignancy or with a history of malignancy with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.'}, 'identificationModule': {'nctId': 'NCT01513902', 'briefTitle': 'Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'A3921103'}, 'secondaryIdInfos': [{'id': '2011-004914-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Ages 12 to less than 18', 'interventionNames': ['Drug: CP-690,550']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Ages 6 to less than 12', 'interventionNames': ['Drug: CP-690,550']}, {'type': 'EXPERIMENTAL', 'label': 'Corhort 3', 'description': 'Ages 2 to less than 6', 'interventionNames': ['Drug: CP-690,550']}], 'interventions': [{'name': 'CP-690,550', 'type': 'DRUG', 'otherNames': ['Tofacitinib'], 'description': 'CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing \\<40 kg. Oral tablets will be used for children weighing ≥40 kg. Children aged 12 to less than 18 years who are unable to swallow tablets will have the option of taking oral solution. Body Weight (kg) Dose (mg) Volume (mL) 5-11 1 1; 12-18 1.5 1.5; 19-24 2 2; 25-31 2.5 2.5; 32-39 3 3; ≥40 5 5', 'armGroupLabels': ['Cohort 1']}, {'name': 'CP-690,550', 'type': 'DRUG', 'otherNames': ['Tofacitinib'], 'description': 'CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing \\<40 kg. Oral tablets will be used for children weighing ≥40 kg. Children less than 12 years of age with a body weight of ≥40 kg will have the option of taking oral solution or tablets. Body Weight (kg) Dose (mg) Volume (mL) 5-11 1 1; 12-18 1.5 1.5; 19-24 2 2; 25-31 2.5 2.5; 32-39 3 3; ≥40 5 5', 'armGroupLabels': ['Cohort 2']}, {'name': 'CP-690,550', 'type': 'DRUG', 'otherNames': ['Tofacitinib'], 'description': 'CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Children with a body weight ≥30 kg will have the option of taking oral solution or tablets, and children weighing \\<30 kg will be dosed with the oral solution. Body Weight (kg) Dose (mg) Volume (mL) 5-6 1 1; 7-9 1.5 1.5; 10-12 2 2; 21-15 2.5 2.5; 16-19 3 3; 20-22 3.5 3.5; 23-26 4 4; 27-29 4.5 4.5; ≥30 5 5', 'armGroupLabels': ['Corhort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Explorer Clinic, University of Minnesota Children's Hospital", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Clinical and Translational Science Institute Masonic Clinical Research Unit (Administration Only)', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': "Randall Children's Hospital at Legacy Emanuel", 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '24576', 'city': 'Bad Bramstedt', 'country': 'Germany', 'facility': 'PRI - Pediatric Rheumatology Research Institute GmbH', 'geoPoint': {'lat': 53.91827, 'lon': 9.88243}}, {'zip': '22081', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Hamburger Zentrum fuer Kinder-und Jugendrheumatologie SchoenKlinik Hamburg Eilbek', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '53757', 'city': 'Sankt Augustin', 'country': 'Germany', 'facility': 'Asklepios Klinik Sankt Augustin Gmbh', 'geoPoint': {'lat': 50.77538, 'lon': 7.197}}, {'zip': '31-503', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '91-738', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Klinika Kardiologii i Reumatologii Dzieciecej', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '921 12', 'city': 'Piešťany', 'country': 'Slovakia', 'facility': 'Narodny ustav reumatickych chorob', 'geoPoint': {'lat': 48.59479, 'lon': 17.82591}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}