Efficacy and Safety Study of MP-435 in Combination With Methotrexate (MTX) in Patients With Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo + Methotrexate; Drug: MP-435(dose1) + Methotrexate

• Registration Number: NCT01143337
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2014-09-10
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-07
• Last Update Submitted: 2014-10-07
• Results First Posted: 2014-10-13
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987) for at least 6 months.
• Subjects who inadequately response for stable dose of MTX.

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Exclusion Criteria

• Patients with Class IV functional activity by the Steinbrocker's scale.
• Patients who have received a biological agent in the past.
• Patients who have other rheumatic diseases, or who have other diseases with joint symptoms.
• Patients with severe or uncontrolled endocrine, psychiatric, cardiac, hematological, pulmonary, hepatic, kidney, gastrointestinal, or thyroid disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo + Methotrexate	Placebo
1	MP-435(dose1) + Methotrexate	dose1

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving American College of Rheumatology 20 (ACR 20) Response	Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)	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\[CRP\]).

Secondary Outcome Measures

Name	Time	Method
Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components	LOCF (Week 12 or discontinuation time)	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.
Percentage of Participants Achieving ACR 50 Response	Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)	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).
Percent Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components	LOCF (Week 12 or discontinuation time)	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).
Percentage of Participants Achieving American College of Rheumatology 70 (ACR 70) Response	Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)	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).

Trial Locations

Locations (1)

Investigational site; 🇯🇵 Osaka, Japan