Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT00132769
Status:
COMPLETED
Last Update Posted:
2015-07-30
First Post:
2005-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Canada', 'Czechia', 'Finland', 'Germany', 'Italy', 'Norway', 'Spain', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'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': 'C532496', 'term': 'MK 0873'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 4 weeks', 'description': 'The safety population consisted of all participants who took at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'MK-0873', 'description': 'Participants receive MK-0873 1.25 mg twice daily for 12 weeks', 'otherNumAtRisk': 53, 'otherNumAffected': 10, 'seriousNumAtRisk': 53, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants receive matching placebo to MK-0873 twice daily for 12 weeks', 'otherNumAtRisk': 53, 'otherNumAffected': 4, 'seriousNumAtRisk': 53, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}], 'seriousEvents': [{'term': 'Uterine Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Mental Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Swollen Joint Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0873', 'description': 'Participants receive MK-0873 1.25 mg twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive matching placebo to MK-0873 twice daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.20', 'groupId': 'OG000', 'lowerLimit': '-9.54', 'upperLimit': '-4.86'}, {'value': '-8.68', 'groupId': 'OG001', 'lowerLimit': '-10.97', 'upperLimit': '-6.39'}]}]}], 'analyses': [{'pValue': '0.278', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '4.18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and the average of Treatment Weeks 8, 10 and 12', 'description': 'Swollen joint count (SJC) was determined by assessing 66 joints (33 right side, 33 left side) for swelling using the following grading system: 0=Absent, 1=Detectable synovial thickening without loss of bony contours, 2=Loss of distinctiveness of bony contours, or 3=Bulging synovial proliferation with cystic characteristics. The total number of joints graded 1, 2, or 3 were then counted to yield the SJC. SJC ranged from 1-66, with increasing score indicating greater number of swollen joints. SJC was averaged over weeks 8, 10 and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean SJC - Baseline SJC.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Patients Treated (APT) population consisted of all participants with a baseline and at least one postbaseline observation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With American College of Rheumatology 20% Response [ACR20]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0873', 'description': 'Participants receive MK-0873 1.25 mg twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive matching placebo to MK-0873 twice daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '39.62', 'groupId': 'OG000'}, {'value': '45.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.543', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.66', 'ciLowerLimit': '-24.45', 'ciUpperLimit': '13.13', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and the average of Treatment Weeks 8, 10 and 12', 'description': 'Participants were categorized as meeting ACR20 criteria when they had at least 20% improvement from Baseline in tender and swollen joint counts, and improvement from Baseline in at least 3 of 5 of the following domains: Pain Visual Analog Scale (VAS), Patient Global Assessement, Physician Global Assessment, Patient Physical Function (Disability) Score and acute-phase reactant (Erythrocyte Sedimentation Rate \\[ESR\\] or C-Reactive Protein \\[CRP\\]). The average percentage of participants that met the ACR20 responder criteria over Treatment Weeks 8, 10 and 12 was calculated.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The APT population consisted of all participants with a baseline and at least one postbaseline observation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joint Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0873', 'description': 'Participants receive MK-0873 1.25 mg twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive matching placebo to MK-0873 twice daily for 12 weeks'}], 'timeFrame': 'Baseline and the average of Treatment Weeks 8, 10 and 12', 'description': 'Tender joint count (TJC) was to be determined by assessing 68 joints (34 right side, 34 left side) for pain using the following grading system: 0=No pain, 1=Patient states that there is pain, 2=Patient states that there is pain and winces, or 3=Patient states that there is pain, winces, and withdraws. The total number of joints graded 1, 2, or 3 were then to be counted to yield the TJC. TJC ranges from 1-68, with increasing score indicating greater number of tender joints. TJC was to be averaged over weeks 8, 10, and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean TJC - Baseline TJC.', 'reportingStatus': 'POSTED', 'populationDescription': 'No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of \\>0.05.'}, {'type': 'SECONDARY', 'title': 'Patient Global Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0873', 'description': 'Participants receive MK-0873 1.25 mg twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive matching placebo to MK-0873 twice daily for 12 weeks'}], 'timeFrame': 'The average of Treatment Weeks 8, 10 and 12', 'description': 'At each clinic visit, participants were to assess disease activity using a 100 mm visual analog scale (VAS) in reponse to the question: "Considering all the ways your arthritis affects you, mark an (X) through the line for how well you are doing." The VAS ranges from "Very Well" (0) to "Very Poor" (100). The mean score at Treatment Weeks 8, 10 and 12 was calculated. A lower score indicates a better disease activity.', 'reportingStatus': 'POSTED', 'populationDescription': 'No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of \\>0.05.'}, {'type': 'SECONDARY', 'title': 'Investigator Global Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0873', 'description': 'Participants receive MK-0873 1.25 mg twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive matching placebo to MK-0873 twice daily for 12 weeks'}], 'timeFrame': 'Treatment Week 12', 'description': 'At each clinic visit, the Investigator was to make a global assessment of participant disease activity on a 5-point Likert scale with grading as follows: 1=Very well, 2=Well, 3=Fair, 4=Poor, or 5=Very poor (scale range: 1-5). A lower score indicates a more positive assessment of participant disease activity.', 'reportingStatus': 'POSTED', 'populationDescription': 'No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of \\>0.05.'}, {'type': 'SECONDARY', 'title': 'Patient Global Assessment of Response to Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0873', 'description': 'Participants receive MK-0873 1.25 mg twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive matching placebo to MK-0873 twice daily for 12 weeks'}], 'timeFrame': 'Treatment Week 12', 'description': 'Participants were to rate their overall response to the study drug on a 5-point Likert scale with grading as follows: 0=None, 1=Poor, 2=Fair, 3=Good, or 4=Excellent (scale range: 0-4). A higher score indicates a more positive response to study drug.', 'reportingStatus': 'POSTED', 'populationDescription': 'No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of \\>0.05.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0873', 'description': 'Participants receive MK-0873 1.25 mg twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive matching placebo to MK-0873 twice daily for 12 weeks'}], 'timeFrame': 'The average of Treatment Weeks 8, 10 and 12', 'description': 'The Stanford Health Assessment Questionnaire Disability Index assesses participant functional ability based on 20 questions in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Responses range from 0=No disability to 3=Completely disabled. The score for each category subscale is the single response within the category with the highest score (greatest difficulty). The overall score for the Disability Index is the mean of the 8 category scores and also ranges from 0-3, with a lower score indicating less disability.', 'reportingStatus': 'POSTED', 'populationDescription': 'No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of \\>0.05.'}, {'type': 'SECONDARY', 'title': "Patient's Assessment of Pain", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0873', 'description': 'Participants receive MK-0873 1.25 mg twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive matching placebo to MK-0873 twice daily for 12 weeks'}], 'timeFrame': 'Treatment Week 12', 'description': 'At each clinic visit, participants were to assess their amount of pain due to arthritis during the previous 48 hours on a 100 mm visual analog scale (VAS) that ranged from "No pain" (0) to "Extreme pain" (100). A lower score indicates less pain.', 'reportingStatus': 'POSTED', 'populationDescription': 'No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of \\>0.05.'}, {'type': 'SECONDARY', 'title': 'Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0873', 'description': 'Participants receive MK-0873 1.25 mg twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive matching placebo to MK-0873 twice daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.70', 'upperLimit': '1.16'}, {'value': '1.08', 'groupId': 'OG001', 'lowerLimit': '0.85', 'upperLimit': '1.38'}]}]}], 'analyses': [{'pValue': '0.225', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean ratio between treatments', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and the average of Treatment Weeks 8, 10 and 12', 'description': 'C-reactive protein levels rise in response to inflammation in the body. The ratio of On-treatment serum C-reative protein:Baseline serum C-reactive protein was calculated to determine a treatment effect. On-treatment C-reactive protein = the mean of serum C-reactive protein levels for Treatment Weeks 8, 10 and 12. A ratio of less than 1.0 is consistent with lower inflammation and was to be considered an improvement.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The APT population consisted of all participants with a baseline and at least one postbaseline observation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK-0873', 'description': 'Participants receive MK-0873 1.25 mg twice daily for 12 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants receive matching placebo to MK-0873 twice daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MK-0873', 'description': 'Participants receive MK-0873 1.25 mg twice daily for 12 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants receive matching placebo to MK-0873 twice daily for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'spread': '9.30', 'groupId': 'BG000'}, {'value': '53.5', 'spread': '8.99', 'groupId': 'BG001'}, {'value': '52.3', 'spread': '9.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-29', 'studyFirstSubmitDate': '2005-08-02', 'resultsFirstSubmitDate': '2013-10-07', 'studyFirstSubmitQcDate': '2005-08-19', 'lastUpdatePostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-17', 'studyFirstPostDateStruct': {'date': '2005-08-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Swollen Joint Count', 'timeFrame': 'Baseline and the average of Treatment Weeks 8, 10 and 12', 'description': 'Swollen joint count (SJC) was determined by assessing 66 joints (33 right side, 33 left side) for swelling using the following grading system: 0=Absent, 1=Detectable synovial thickening without loss of bony contours, 2=Loss of distinctiveness of bony contours, or 3=Bulging synovial proliferation with cystic characteristics. The total number of joints graded 1, 2, or 3 were then counted to yield the SJC. SJC ranged from 1-66, with increasing score indicating greater number of swollen joints. SJC was averaged over weeks 8, 10 and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean SJC - Baseline SJC.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With American College of Rheumatology 20% Response [ACR20]', 'timeFrame': 'Baseline and the average of Treatment Weeks 8, 10 and 12', 'description': 'Participants were categorized as meeting ACR20 criteria when they had at least 20% improvement from Baseline in tender and swollen joint counts, and improvement from Baseline in at least 3 of 5 of the following domains: Pain Visual Analog Scale (VAS), Patient Global Assessement, Physician Global Assessment, Patient Physical Function (Disability) Score and acute-phase reactant (Erythrocyte Sedimentation Rate \\[ESR\\] or C-Reactive Protein \\[CRP\\]). The average percentage of participants that met the ACR20 responder criteria over Treatment Weeks 8, 10 and 12 was calculated.'}, {'measure': 'Change From Baseline in Tender Joint Count', 'timeFrame': 'Baseline and the average of Treatment Weeks 8, 10 and 12', 'description': 'Tender joint count (TJC) was to be determined by assessing 68 joints (34 right side, 34 left side) for pain using the following grading system: 0=No pain, 1=Patient states that there is pain, 2=Patient states that there is pain and winces, or 3=Patient states that there is pain, winces, and withdraws. The total number of joints graded 1, 2, or 3 were then to be counted to yield the TJC. TJC ranges from 1-68, with increasing score indicating greater number of tender joints. TJC was to be averaged over weeks 8, 10, and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean TJC - Baseline TJC.'}, {'measure': 'Patient Global Assessment of Disease Activity', 'timeFrame': 'The average of Treatment Weeks 8, 10 and 12', 'description': 'At each clinic visit, participants were to assess disease activity using a 100 mm visual analog scale (VAS) in reponse to the question: "Considering all the ways your arthritis affects you, mark an (X) through the line for how well you are doing." The VAS ranges from "Very Well" (0) to "Very Poor" (100). The mean score at Treatment Weeks 8, 10 and 12 was calculated. A lower score indicates a better disease activity.'}, {'measure': 'Investigator Global Assessment of Disease Activity', 'timeFrame': 'Treatment Week 12', 'description': 'At each clinic visit, the Investigator was to make a global assessment of participant disease activity on a 5-point Likert scale with grading as follows: 1=Very well, 2=Well, 3=Fair, 4=Poor, or 5=Very poor (scale range: 1-5). A lower score indicates a more positive assessment of participant disease activity.'}, {'measure': 'Patient Global Assessment of Response to Therapy', 'timeFrame': 'Treatment Week 12', 'description': 'Participants were to rate their overall response to the study drug on a 5-point Likert scale with grading as follows: 0=None, 1=Poor, 2=Fair, 3=Good, or 4=Excellent (scale range: 0-4). A higher score indicates a more positive response to study drug.'}, {'measure': 'Health Assessment Questionnaire Disability Index', 'timeFrame': 'The average of Treatment Weeks 8, 10 and 12', 'description': 'The Stanford Health Assessment Questionnaire Disability Index assesses participant functional ability based on 20 questions in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Responses range from 0=No disability to 3=Completely disabled. The score for each category subscale is the single response within the category with the highest score (greatest difficulty). The overall score for the Disability Index is the mean of the 8 category scores and also ranges from 0-3, with a lower score indicating less disability.'}, {'measure': "Patient's Assessment of Pain", 'timeFrame': 'Treatment Week 12', 'description': 'At each clinic visit, participants were to assess their amount of pain due to arthritis during the previous 48 hours on a 100 mm visual analog scale (VAS) that ranged from "No pain" (0) to "Extreme pain" (100). A lower score indicates less pain.'}, {'measure': 'Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein', 'timeFrame': 'Baseline and the average of Treatment Weeks 8, 10 and 12', 'description': 'C-reactive protein levels rise in response to inflammation in the body. The ratio of On-treatment serum C-reative protein:Baseline serum C-reactive protein was calculated to determine a treatment effect. On-treatment C-reactive protein = the mean of serum C-reactive protein levels for Treatment Weeks 8, 10 and 12. A ratio of less than 1.0 is consistent with lower inflammation and was to be considered an improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by participants with the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rheumatoid arthritis, according to the American College of Rheumatology criteria, with active disease despite current medications\n* Other criteria also apply\n\nExclusion Criteria:\n\n* Other major illnesses\n* Past history of certain other disorders\n* Certain prohibited medications'}, 'identificationModule': {'nctId': 'NCT00132769', 'briefTitle': 'A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK-0873 in Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': '0873-012'}, 'secondaryIdInfos': [{'id': '2005_029', 'type': 'OTHER', 'domain': 'Telerex Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-0873', 'description': 'MK-0873 1.25 mg twice daily for 12 weeks', 'interventionNames': ['Drug: MK-0873']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks', 'interventionNames': ['Drug: Comparator: Placebo']}], 'interventions': [{'name': 'MK-0873', 'type': 'DRUG', 'description': 'MK-0873 1.25 mg twice daily for 12 weeks', 'armGroupLabels': ['MK-0873']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}