Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-02-20 @ 4:49 PM
Study NCT ID:
NCT02045732
Status:
TERMINATED
Last Update Posted:
2017-01-16
First Post:
2014-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000710975', 'term': 'monoclonal antibody RN168'}]}}, '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.\n\nInvestigator 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}, 'limitationsAndCaveats': {'description': 'Due to the early termination of the study, the small enrollment number and minimal data, no statistical analyses were performed.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline through Day 127/Early Termination.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo SC every other week during an 85-day treatment period.', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PF-06342674', 'description': 'Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo SC every other week during an 85-day treatment period.'}, {'id': 'OG001', 'title': 'PF-06342674 0.25 mg/kg', 'description': 'Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Withdrawals Due to AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Day 127/Early Termination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug. An 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 are events between first dose of study drug and up to Day 127/Early Termination that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Treatment-Emergent AEs and SAEs by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo SC every other week during an 85-day treatment period.'}, {'id': 'OG001', 'title': 'PF-06342674 0.25 mg/kg', 'description': 'Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Day 127/Early Termination', 'description': "AE severity was graded as mild, moderate, or severe. Mild AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.", 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo SC every other week during an 85-day treatment period.'}, {'id': 'OG001', 'title': 'PF-06342674 0.25 mg/kg', 'description': 'Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Day 127/Early Termination', 'description': 'Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, electrolytes, hormones, clinical chemistry, and urinalysis (dipstick and microscopy). Abnormal laboratory findings included: lymphocytes (absolute) less than (\\<)0.8 x lower limit of normal (LLN); urine blood/hemoglobin (qualitative) more than or equal to (\\>=)1; urine nitrite \\>=1; urine leukocyte esterase \\>=1; urine red blood cell (RBC) \\>=20/high-power field (HPF).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Changes in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo SC every other week during an 85-day treatment period.'}, {'id': 'OG001', 'title': 'PF-06342674 0.25 mg/kg', 'description': 'Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.'}], 'classes': [{'title': 'Supine SBP <90 mm Hg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Supine DBP <50 mm Hg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Increase in supine SBP >=30 mm Hg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in supine SBP >=30 mm Hg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Increase in supine DBP >=20 mm Hg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in supine DBP >=20 mm Hg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Supine pulse rate <40 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Supine pulse rate >120 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Day 127/Early Termination', 'description': 'Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of \\<90 millimeters of mercury (mm Hg) or change in supine SBP of \\>=30 mm Hg; supine diastolic blood pressure (DBP) of \\<50 mm Hg or change in supine DBP of \\>=20 mm Hg; supine pulse rate of \\<40 or more than (\\>)120 beats per minute (bpm).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Electrocardiogram (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo SC every other week during an 85-day treatment period.'}, {'id': 'OG001', 'title': 'PF-06342674 0.25 mg/kg', 'description': 'Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.'}], 'classes': [{'title': 'QTcF Interval 450-<480 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval >=480 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval 30-<60 msec Increase From Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval >=60 msec Increase From Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval 30-<60 msec Decrease From Baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval >=60 msec Decrease From Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Day 127/Early Termination', 'description': 'Criteria for potential clinical concern in ECG parameters: The maximum of the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) \\>=450 milliseconds (msec), maximum QTcF interval change from baseline in range of 30 to \\<60 msec and \\>=60 msec.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of all participants who received at least 1 dose of study drug. The QTcF interval of the participant in the placebo arm was in this range of 450 to \\<480 msec at Baseline. This participant experienced a decrease in QTcF of 30 to \\<60 msec on Day 30, which then returned to baseline levels on Day 57.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo SC every other week during an 85-day treatment period.'}, {'id': 'OG001', 'title': 'PF-06342674 0.25 mg/kg', 'description': 'Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination', 'description': 'Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive enzyme-linked immunosorbent assay (ELISA) result in combination with a negative baseline sample ELISA result. ADA positive was defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) \\>=4.32.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population consists of all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Concentration of PF-06342674', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo SC every other week during an 85-day treatment period.'}, {'id': 'OG001', 'title': 'PF-06342674 0.25 mg/kg', 'description': 'Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Due to the early termination of the study, the small enrollment number and minimal data, concentration data were not summarized.', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline through Day 127/Early Termination', 'unitOfMeasure': 'nanogram/milliliter (ng/ml)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the placebo arm did not receive PF-06342674. Due to the early termination of the study, the small enrollment number and minimal data, concentration data were listed but not summarized, and pharmacokinetic (PK) parameters were not calculated for the PF-06342674 0.25 mg/kg arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo subcutaneously (SC) every other week during an 85-day treatment period.'}, {'id': 'FG001', 'title': 'PF-06342674 0.25 mg/kg', 'description': 'Participants received PF-06342674 0.25 milligram (mg)/kilogram (kg) SC every other week during an 85-day treatment period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'At the discretion of the investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was a Phase 1b, randomized, multi-center, double-blind, sponsor-open, placebo controlled study to evaluate multiple ascending doses of PF-06342674 in participants with Multiple Sclerosis (MS). Up to 60 participants were planned to be enrolled. However, only 4 participants were randomized due to the early termination of the study.', 'preAssignmentDetails': 'Participants were screened within 45 days prior to the first administration of the study drug to confirm that they met the participant inclusion criteria for the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo SC every other week during an 85-day treatment period.'}, {'id': 'BG001', 'title': 'PF-06342674 0.25 mg/kg', 'description': 'Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '0', 'groupId': 'BG000'}, {'value': '45.3', 'spread': '14.2', 'groupId': 'BG001'}, {'value': '42.3', 'spread': '13.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'This study terminated on April 8, 2015 due to a corporate decision and not related to the safety or efficacy of the protocol.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-18', 'studyFirstSubmitDate': '2014-01-22', 'resultsFirstSubmitDate': '2016-11-18', 'studyFirstSubmitQcDate': '2014-01-22', 'lastUpdatePostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-18', 'studyFirstPostDateStruct': {'date': '2014-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs', 'timeFrame': 'Baseline through Day 127/Early Termination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug. An 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 are events between first dose of study drug and up to Day 127/Early Termination that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.'}, {'measure': 'Number of Treatment-Emergent AEs and SAEs by Severity', 'timeFrame': 'Baseline through Day 127/Early Termination', 'description': "AE severity was graded as mild, moderate, or severe. Mild AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function."}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities', 'timeFrame': 'Baseline through Day 127/Early Termination', 'description': 'Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, electrolytes, hormones, clinical chemistry, and urinalysis (dipstick and microscopy). Abnormal laboratory findings included: lymphocytes (absolute) less than (\\<)0.8 x lower limit of normal (LLN); urine blood/hemoglobin (qualitative) more than or equal to (\\>=)1; urine nitrite \\>=1; urine leukocyte esterase \\>=1; urine red blood cell (RBC) \\>=20/high-power field (HPF).'}, {'measure': 'Number of Participants With Clinically Significant Changes in Vital Signs', 'timeFrame': 'Baseline through Day 127/Early Termination', 'description': 'Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of \\<90 millimeters of mercury (mm Hg) or change in supine SBP of \\>=30 mm Hg; supine diastolic blood pressure (DBP) of \\<50 mm Hg or change in supine DBP of \\>=20 mm Hg; supine pulse rate of \\<40 or more than (\\>)120 beats per minute (bpm).'}, {'measure': 'Number of Participants With Abnormal Electrocardiogram (ECG)', 'timeFrame': 'Baseline through Day 127/Early Termination', 'description': 'Criteria for potential clinical concern in ECG parameters: The maximum of the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) \\>=450 milliseconds (msec), maximum QTcF interval change from baseline in range of 30 to \\<60 msec and \\>=60 msec.'}, {'measure': 'Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs)', 'timeFrame': 'Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination', 'description': 'Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive enzyme-linked immunosorbent assay (ELISA) result in combination with a negative baseline sample ELISA result. ADA positive was defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) \\>=4.32.'}], 'secondaryOutcomes': [{'measure': 'Concentration of PF-06342674', 'timeFrame': 'Baseline through Day 127/Early Termination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'MRI'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4351002&StudyName=A%20Study%20To%20Evaluate%20The%20Safety%20And%20Tolerability%20Of%20PF-06342674%20%28RN168%29%20In%20Subjects%20with%20Multiple%20Sclerosis%20%28MS%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'PF-06342674 (RN168), being developed for the treatment of multiple sclerosis (MS), is an antibody that binds to and inhibits the human interleukin-7 receptor, a component potentially involved in MS. PF-06342674 (RN168) is expected to play a role in slowing down the progression of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women and men aged 18-55 yrs.\n* Confirmed diagnosis of Multiple Sclerosis (MS) according to the 2010 revision of the McDonald Criteria.\n* Expanded Disability Status Scale (EDSS) between 0-5, inclusive.\n\nExclusion Criteria:\n\n* Relapse episode of MS within 2 weeks of enrollment.\n* Primary progressive MS without a relapsing component.\n* Intolerant or unwilling to undergo MRI scanning. Treatment with disease modifying agents up to 6 weeks prior to enrollment.'}, 'identificationModule': {'nctId': 'NCT02045732', 'briefTitle': 'A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1b, Double-blinded, Placebo-controlled, Randomized Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Doses Of Pf-06342674 (rn168) In Subjects With Multiple Sclerosis (ms)', 'orgStudyIdInfo': {'id': 'B4351002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'interventionNames': ['Biological: PF-06342674 0.25 mg/kg', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PF-06342674 1.5 mg/kg', 'interventionNames': ['Biological: Placebo', 'Biological: PF-06342674 1.5 mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'PF-06342674 6.0 mg/kg (q2 Weeks)', 'interventionNames': ['Biological: Placebo', 'Biological: PF-06342674 6.0 mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'PF-06342674 6.0 mg/kg (q1 Week)', 'interventionNames': ['Biological: Placebo', 'Biological: PF-06342674 6.0 mg/kg']}], 'interventions': [{'name': 'PF-06342674 0.25 mg/kg', 'type': 'BIOLOGICAL', 'description': 'Bi-Weekly Subcutaneous Injections X 6', 'armGroupLabels': ['Cohort 1']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Bi-Weekly Subcutaneous Injections X 6', 'armGroupLabels': ['Cohort 1', 'PF-06342674 1.5 mg/kg', 'PF-06342674 6.0 mg/kg (q1 Week)', 'PF-06342674 6.0 mg/kg (q2 Weeks)']}, {'name': 'PF-06342674 1.5 mg/kg', 'type': 'BIOLOGICAL', 'description': 'Bi-Weekly Subcutaneous Injections X 6', 'armGroupLabels': ['PF-06342674 1.5 mg/kg']}, {'name': 'PF-06342674 6.0 mg/kg', 'type': 'BIOLOGICAL', 'description': 'Bi-Weekly Subcutaneous Injections X 6', 'armGroupLabels': ['PF-06342674 6.0 mg/kg (q1 Week)', 'PF-06342674 6.0 mg/kg (q2 Weeks)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12205', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Advanced Imaging', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '12110', 'city': 'Latham', 'state': 'New York', 'country': 'United States', 'facility': 'Fallon Wellness Pharmacy', 'geoPoint': {'lat': 42.74702, 'lon': -73.75901}}, {'zip': '12110', 'city': 'Latham', 'state': 'New York', 'country': 'United States', 'facility': 'Northeast Eye Center', 'geoPoint': {'lat': 42.74702, 'lon': -73.75901}}, {'zip': '12110', 'city': 'Latham', 'state': 'New York', 'country': 'United States', 'facility': 'The MS Center of Northeastern New York', 'geoPoint': {'lat': 42.74702, 'lon': -73.75901}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73013', 'city': 'Edmond', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Retina Vitreous Center', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lynn Health Science Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Radiology Associates (X-ray facility only)', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}