A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking Methotrexate
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT02884635
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The objective of this study is to evaluate the efficacy, pharmacokinetics, pharmacodynamics and safety of ASP1707 in combination with MTX in postmenopausal female patients with RA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 72
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Subject has RA that was diagnosed according to the 1987 ACR criteria or the 2010 ACR/EULAR criteria.
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Subject meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III.
-
subject has active RA as evidenced by both of the followings:
- ≥ 6 tender/painful joints (using 68-joint assessment)
- ≥ 6 swollen joints (using 66-joint assessment)
-
CRP (C-reactive protein) of > 0.3 mg/dL or ESR (Erythrocyte sedimentation rate) of > 28 mm/hr at screening.
-
Subject who continuously received MTX and who is able to continue stable dose of MTX.
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Subject who did not receive the following drugs, or received the drugs with stable dosage:
Non-steroidal anti-inflammatory drugs, oral morphine or equivalent opioid analgesics, acetaminophen, or oral corticosteroids.
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Inadequate responders to a biologic DMARD (Disease-modifying antirheumatic drug).
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Subject has taken other investigational research products are prohibited within 12 weeks (84 days) or within 5 half-lives, whichever is longer, prior to screening.
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Subject has undergone surgery which has residual effects on the assessed joints, or is scheduled to undergo surgery that may affect the study evaluation of the assessed joints.
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Subject has another type of inflammatory arthritis other than RA.
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Subject who meets any of the following criteria of laboratory values at screening:
- White blood cell count <4000/μL
- Platelet count <100000/μL
- ALT (Alanine Aminotransferase) ≥ 2 x ULN (Upper Limit of Normal)
- AST (Aspartate Aminotransferase) ≥ 2 x ULN
- Total bilirubin ≥ 1.5 x ULN
- Positive Hepatitis B surface antigen, Hepatitis B virus-DNA quantitation, or Hepatitis C virus antibody
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Subject has a positive QuantiFERON-TB Gold test or T-spot.
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Subject has a history of or concurrent malignant tumor.
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Subject has any ongoing severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, infectious, or autoimmune disease except for RA, or diseases which preclude the subject's participation in the study.
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Subject has a history of clinically significant allergy.
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Subject has clinically significant abnormalities on the 12-lead Electrocardiogram.
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Subject has a history of positive Human Immunodeficiency Virus infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo will be orally administered for 12 weeks. Placebo Methotrexate Placebo will be orally administered for 12 weeks. ASP1707 ASP1707 ASP1707 will be orally administered for 12 weeks. ASP1707 Methotrexate ASP1707 will be orally administered for 12 weeks.
- Primary Outcome Measures
Name Time Method ACR20 response rate Week 12 ACR20: American College of Rheumatology 20
- Secondary Outcome Measures
Name Time Method ACR50 response rate Up to Week 12 Change from baseline in Tender Joint Count (68 joints) Baseline and Up to Week 12 Change from baseline in Swollen Joint Count (66 joints) Baseline and Up to Week 12 Change from baseline in CRP Baseline and Up to Week 12 Percentage of subjects achieving EULAR response criterion of "Good Response" Up to Week 12 EULAR: European league Against Rheumatism
ACR20 response rate Up to Week 8 Percentage of subjects achieving DAS28-CRP score and DAS28-ESR score for remission (<2.6) Up to Week 12 Percentage of subjects achieving DAS28-CRP score and DAS28-ESR score for low disease activity (≤3.2) Up to Week 12 ACR70 response rate Up to Week 12 Change from baseline in ESR Baseline and Up to Week 12 Safety assessed by incidence of adverse events Up to Week 13 Safety assessed by pulse rate Up to Week 13 Safety assessed by laboratory tests: Hematology Up to Week 13 Safety assessed by laboratory tests: Biochemistry Up to Week 13 Safety assessed by laboratory tests: Urinalysis Up to Week 13 Change from baseline in DAS28-CRP score Baseline and Up to Week 12 DAS28-CRP: Disease Activity Score28 - C-reactive protein
Change from baseline in DAS28-ESR score Baseline and Up to Week 12 DAS28-ESR: Disease Activity Score28 - Erythrocyte sedimentation rate
Change from baseline in the SDAI score Baseline and Up to Week 12 Safety assessed by body temperature Up to Week 13 Safety assessed by standard 12-lead electrocardiogram Up to Week 13 Safety assessed by weight Up to Week 13 Pharmacodynamics assessed by plasma concentration of TNF-α Up to Week 13 TNF: Tumor Necrosis Factor
Percentage of subjects achieving ACR/EULAR score for remission Up to Week 12 Percentage of subjects achieving SDAI score ≦ 3.3 (SDAI remission) Up to Week 12 SDAI: Simplified Disease Activity Index
Plasma concentration of metabolite of ASP1707 Up to Week 12 Pharmacodynamics assessed by endocrinology tests Up to Week 13 Percentage of subjects achieving EULAR response criterion of "Good Response" or "Moderate Response" Up to Week 12 Change from baseline for the HAQ-DI Baseline and Up to Week 12 HAQ-DI: Health Assessment Questionnaire - Disability Index
Safety assessed by blood pressure in sitting position Up to Week 13 Pharmacodynamics assessed by plasma concentration of MMP3 Up to Week 13 MMP3: Matrix metalloproteinase 3
Plasma concentration of ASP1707 Up to Week 12 Pharmacodynamics assessed by plasma concentration of IL-6 Up to Week 13 IL-6: Interleukin-6
Trial Locations
- Locations (27)
Site JP00010
🇯🇵Hiroshima, Japan
Site JP00022
🇯🇵Aichi, Japan
Site JP00023
🇯🇵Aichi, Japan
Site JP00006
🇯🇵Gunma, Japan
Site JP00024
🇯🇵Gunma, Japan
Site JP00011
🇯🇵Hiroshima, Japan
Site JP00018
🇯🇵Fukuoka, Japan
Site JP00019
🇯🇵Fukuoka, Japan
Site JP00021
🇯🇵Kanagawa, Japan
Site JP00020
🇯🇵Oita, Japan
Site JP00015
🇯🇵Kumamoto, Japan
Site JP00013
🇯🇵Nagasaki, Japan
Site JP00009
🇯🇵Shizuoka, Japan
Site JP00004
🇯🇵Iwate, Japan
Site JP00026
🇯🇵Ehime, Japan
Site JP00001
🇯🇵Hokkaido, Japan
Site JP00008
🇯🇵Shizuoka, Japan
Site JP00002
🇯🇵Hokkaido, Japan
Site JP00016
🇯🇵Kagoshima, Japan
Site JP00007
🇯🇵Kanagawa, Japan
Site JP00014
🇯🇵Kumamoto, Japan
Site JP00017
🇯🇵Chiba, Japan
Site JP00012
🇯🇵Fukuoka, Japan
Site JP00025
🇯🇵Fukui, Japan
Site JP00005
🇯🇵Iwate, Japan
Site JP00003
🇯🇵Hokkaido, Japan
Site JP00027
🇯🇵Tokyo, Japan