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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002181-12 | EudraCT Number |
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The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate (MTX) in participants with active rheumatoid arthritis (RA) and an inadequate response or intolerance to anti-tumor necrosis factor α (anti-TNF-α) therapy. The primary hypothesis of this study is that among participants with active RA, MK-8457 100 mg twice daily (BID) + MTX will be superior to placebo + MTX as measured by the change in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) after 12 weeks of treatment.
In the Base Study, participants were to receive blinded MK-8457 100 mg + MTX or matched placebo + MTX for up to 24 weeks. At Week 12 and 18, efficacy evaluation was conducted to assess eligibility for early escape, defined as <20% improvement in tender and swollen joint counts. Participants who completed the Base Study and those eligible for early escape could enroll in the 76-week Safety Extension in which participants were to receive open-label MK-8457 100 mg BID + MTX.
All participants must have been treated with MTX for at least 3 months prior to Screening and have been receiving a stable dose of MTX for at least 4 weeks prior to Screening. In addition, each participant must have either failed treatment with 1 or 2 anti-TNF-α therapies or was intolerant to anti-TNF-α therapy prior to Screening. For participants who failed therapy, the treatment with anti-TNF-α therapies must have been for at least 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Base Study: MK-8457 | Experimental | Participants received MK-8457 100 mg dosed twice daily (BID) orally with MTX at the stable dose received upon study enrollment. The Base Study lasted up to 24 weeks. |
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| Base Study: Placebo | Placebo Comparator | Participants received placebo BID orally with MTX at the stable dose received upon study enrollment. The Base Study lasted up to 24 weeks. |
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| Safety Extension: MK-8457 | Experimental | Participants received MK-8457 100 mg dosed twice daily (BID) orally with MTX at the stable dose received upon study enrollment. The Safety Extension was to last up to 76 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8457 100 mg | Drug | MK-8457 100 mg dosed orally BID |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Disease Activity Score (DAS28) as Measured by C-Reactive Protein (CRP) at Week 12 | The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints; 0=absent, 1=present; TEN28), swollen joints (28 joints; 0=absent, 1=present; SW28), CRP (an inflammatory marker, decrease indicates improvement), and Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) (0=doing very well to 100=doing very poor; GH). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. This outcome measure applied to Base Study participants only. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 | ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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This trial was conducted at 53 clinical centers in the United States, Australia, Columbia, Denmark, France, Greece, Hungary, Italy, New Zealand, Poland, South Africa, Spain, and in the United Kingdom. A total of 120 participants were screened and 56 were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Base Study: MK-8457 | MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study |
| FG001 | Base Study: Placebo | Placebo BID + MTX for up to 24 weeks in the Base Study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Base Study |
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| Methotrexate | Drug | MTX dosed at the stable dose received upon study entry |
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| Dose-match placebo | Drug | Dose-matched placebo dosed orally BID |
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| Week 12 |
| Percentage of Participants Achieving an ACR20 Response at Week 24 | ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only. | Week 24 |
| Percentage of Participants Achieving an ACR50 Response at Week 12 | ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR50 response is defined as a ≥50% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥50% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only. | Week 12 |
| Change From Baseline in DAS28-CRP at Week 24 | The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints; 0=absent, 1=present; TEN28), swollen joints (28 joints; 0=absent, 1=present; SW28), CRP (decrease indicates improvement), and Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) (0=doing very well to 100=doing very poor; GH, ). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. This outcome measure applied to Base Study participants only. | Baseline and Week 24 |
| Change From Baseline in the Health Assessment Questionnaire Disability (HAQ Disability Index) at Week 12 | The functional status of the participant was assessed using the Disability Index of the HAQ on a Likert scale. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. The overall score for the Disability Index is the mean of the 8 functional area scores and also ranges from 0 to 3, with a lower score indicating less disability. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only. | Baseline and Week 12 |
| Percentage of Participants Achieving an ACR50 Response at Week 24 | ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR50 response is defined as a ≥50% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0=Absent; 1=Present) and 2) ≥50% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, 0=no pain to 100=extreme pain); b) Patient's Global Assessment of Disease Activity VAS (0=doing very well to 100=doing very poor); c) Investigator's Global Assessment of Disease Activity VAS (0=doing very well to 100=doing very poor; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from 0=no difficulty to 24=inability to perform tasks; and e) CRP (decrease indicates improvement). This outcome measure applied to Base Study participants only. | Week 24 |
| Change From Baseline in the HAQ Disability Index at Week 24 | The functional status of the participant was assessed using the Disability Index of the HAQ on a Likert scale. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. The overall score for the Disability Index is the mean of the 8 functional area scores and also ranges from 0 to 3, with a lower score indicating less disability. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only. | Baseline and Week 24 |
| FG002 | Extension Study: MK-8457 | MK-8457 100 mg BID + MTX for up to 76 weeks in the Extension Study. Participants who completed or had early escape from the Base Study were eligible to enroll in the Extension Study. |
| COMPLETED |
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| NOT COMPLETED |
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| Extension Study |
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All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Base Study: MK-8457 | MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study |
| BG001 | Base Study: Placebo | Placebo BID + MTX for up to 24 weeks in the Base Study |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Disease Activity Score (DAS28) as Measured by C-Reactive Protein (CRP) at Week 12 | The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints; 0=absent, 1=present; TEN28), swollen joints (28 joints; 0=absent, 1=present; SW28), CRP (an inflammatory marker, decrease indicates improvement), and Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) (0=doing very well to 100=doing very poor; GH). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. This outcome measure applied to Base Study participants only. | Randomized participants in the Base Study who received at least one dose of study drug and had both Baseline and Week 12 DAS28-CRP measurements | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline and Week 12 |
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| Secondary | Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 | ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only. | Randomized participants in the Base Study who received at least one dose of study drug and had at least one post-baseline ACR20 measurement (last observation carried forward) | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving an ACR20 Response at Week 24 | ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only. | Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available. | Posted | Week 24 |
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| Secondary | Percentage of Participants Achieving an ACR50 Response at Week 12 | ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR50 response is defined as a ≥50% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥50% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only. | Randomized participants in the Base Study who received at least one dose of study drug and had at least one post-baseline ACR50 measurement (last observation carried forward) | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | Change From Baseline in DAS28-CRP at Week 24 | The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints; 0=absent, 1=present; TEN28), swollen joints (28 joints; 0=absent, 1=present; SW28), CRP (decrease indicates improvement), and Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) (0=doing very well to 100=doing very poor; GH, ). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. This outcome measure applied to Base Study participants only. | Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available. | Posted | Baseline and Week 24 |
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| Secondary | Change From Baseline in the Health Assessment Questionnaire Disability (HAQ Disability Index) at Week 12 | The functional status of the participant was assessed using the Disability Index of the HAQ on a Likert scale. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. The overall score for the Disability Index is the mean of the 8 functional area scores and also ranges from 0 to 3, with a lower score indicating less disability. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only. | Randomized participants in the Base Study who received at least one dose of study drug and had both Baseline and Week 12 HAQ Disability Index measurement | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline and Week 12 |
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| Secondary | Percentage of Participants Achieving an ACR50 Response at Week 24 | ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR50 response is defined as a ≥50% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0=Absent; 1=Present) and 2) ≥50% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, 0=no pain to 100=extreme pain); b) Patient's Global Assessment of Disease Activity VAS (0=doing very well to 100=doing very poor); c) Investigator's Global Assessment of Disease Activity VAS (0=doing very well to 100=doing very poor; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from 0=no difficulty to 24=inability to perform tasks; and e) CRP (decrease indicates improvement). This outcome measure applied to Base Study participants only. | Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available. | Posted | Week 24 |
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| Secondary | Change From Baseline in the HAQ Disability Index at Week 24 | The functional status of the participant was assessed using the Disability Index of the HAQ on a Likert scale. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. The overall score for the Disability Index is the mean of the 8 functional area scores and also ranges from 0 to 3, with a lower score indicating less disability. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only. | Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available. | Posted | Baseline and Week 24 |
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Base Study: up to 24 weeks: Extension Study: up to approximately 40 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Base Study: MK-8457 | MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study | 5 | 30 | 10 | 30 | ||
| EG001 | Base Study: Placebo | Placebo BID + MTX for up to 24 weeks in the Base Study | 0 | 26 | 2 | 26 | ||
| EG002 | Extension Study: MK-8457 | MK-8457 100 mg BID + MTX for up to 76 weeks in the Extension Study. Participants who completed or had early escape from the Base Study were eligible to enroll in the Extension Study | 2 | 14 | 6 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 16.1 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA version 16.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA version 16.1 | Systematic Assessment |
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| Atrioventricular block first degree | Cardiac disorders | MedDRA version 16.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment |
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| Mouth injury | Injury, poisoning and procedural complications | MedDRA version 16.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA version 16.1 | Systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA version 16.1 | Systematic Assessment |
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This study was terminated early (12 September 2013) based on preliminary analysis of data. The results of this study need to be interpreted with caution given the small sample size (56 participants) resulting from early termination of the study.
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. Any information identified by the sponsor as confidential must be deleted prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck, Sharp & Dohme Corp. | 1-800-672-6372 | ClinialTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| ≥65 years |
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| Male |
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