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The purpose of this study is to determine the Efficacy, Safety, and Pharmacokinetics of MP-435 administered for 12 weeks in subjects with rheumatoid arthritis (RA) on stable doses of Methotrexate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | dose1 |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-435(dose1) + Methotrexate | Drug | MP-435 dose1 + stable weekly dose of Methotrexate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20 (ACR 20) Response | ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count [TJC and SJC] and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ-DI]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]). | Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving ACR 50 Response | ACR 50 response is a decrease of at least 50 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain VAS with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; HAQ-DI: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; CRP). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Osaka | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy. |
| FG001 | MP-435 100mg BID | MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy. |
| FG002 | MP-435 400mg BID | MP-435 400mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy. |
| BG001 | MP-435 100mg BID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Percentage of Participants Achieving American College of Rheumatology 20 (ACR 20) Response | ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count [TJC and SJC] and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ-DI]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]). | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time) |
|
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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 | Placebo | MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tuberculous pleurisy | Infections and infestations | MedDRA (14.1) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Placebo + Methotrexate |
| Drug |
Placebo + stable weekly dose of Methotrexate |
|
| Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time) |
| Percentage of Participants Achieving American College of Rheumatology 70 (ACR 70) Response | ACR 70 response is a decrease of at least 70 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain VAS with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; HAQ-DI: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; CRP). | Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time) |
| Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components | DAS28 (CRP) is calculated using TJC, SJC C-Reactive Protein ( CRP in mg/dL ), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x log (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity. DAS28 (ESR) is calculated using TJC, SJC erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x log (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative change score indicates improvement. Higher score indicated more disease activity. DAS28 =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity. | LOCF (Week 12 or discontinuation time) |
| Percent Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components | ACR components are tender joints count (TJC), swollen joints count (SJC), participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR). | LOCF (Week 12 or discontinuation time) |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Other reason |
|
MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
MP-435 400mg:
There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.
Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis.
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | MP-435 100mg BID | MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy. MP-435 400mg: There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point. Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis. |
|
|
| Secondary | Percentage of Participants Achieving ACR 50 Response | ACR 50 response is a decrease of at least 50 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain VAS with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; HAQ-DI: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; CRP). | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time) |
|
|
|
| Secondary | Percentage of Participants Achieving American College of Rheumatology 70 (ACR 70) Response | ACR 70 response is a decrease of at least 70 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain VAS with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; HAQ-DI: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; CRP). | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time) |
|
|
|
| Secondary | Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components | DAS28 (CRP) is calculated using TJC, SJC C-Reactive Protein ( CRP in mg/dL ), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x log (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity. DAS28 (ESR) is calculated using TJC, SJC erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x log (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative change score indicates improvement. Higher score indicated more disease activity. DAS28 =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity. | Posted | Mean | Standard Deviation | units on a scale | LOCF (Week 12 or discontinuation time) |
|
|
|
| Secondary | Percent Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components | ACR components are tender joints count (TJC), swollen joints count (SJC), participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR). | Posted | Mean | Standard Deviation | percentage of change from baseline | LOCF (Week 12 or discontinuation time) |
|
|
|
| 3 |
| 49 |
| 11 |
| 49 |
| EG001 | MP-435 100mg BID | MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy. MP-435 400mg: There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point. Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis. | 0 | 50 | 22 | 50 |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (14.1) |
|
| Liver function test abnormal | Investigations | MedDRA (14.1) |
|
| Headache | Nervous system disorders | MedDRA (14.1) |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (14.1) |
|
| Liver function test abnormal | Investigations | MedDRA (14.1) |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Week 6 |
|
| Week 8 |
|
| Week 12 |
|
| LOCF (Week 12 or discontinuation time) |
|
| Week 6 |
|
| Week 8 |
|
| Week 12 |
|
| LOCF (Week 12 or discontinuation time) |
|
| DAS 28 (ESR) Week 0 |
|
| DAS 28 (ESR) Week 12 or discontinuation time |
|
| participant assessment |
|
| participant global assessment of disease activity |
|
| physician global assessment of disease activity |
|
| HAQ-DI |
|
| CRP |
|
| ESR |
|