Back to resultsA Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking Methotrexate
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ASP1707
Placebo
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Methotrexate, ASP1707, Rheumatoid arthritis
Eligibility Criteria
Inclusion Criteria:
- Subject has RA that was diagnosed according to the 1987 ACR criteria or the 2010 ACR/EULAR criteria.
- 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.
- 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.
Exclusion Criteria:
- Inadequate responders to a biologic DMARD (Disease-modifying antirheumatic drug).
- 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.
- 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.
- Subject has another type of inflammatory arthritis other than RA.
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
- Subject has a positive QuantiFERON-TB Gold test or T-spot.
- Subject has a history of or concurrent malignant tumor.
- 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.
- Subject has a history of clinically significant allergy.
- Subject has clinically significant abnormalities on the 12-lead Electrocardiogram.
- Subject has a history of positive Human Immunodeficiency Virus infection.
Sites / Locations
- Site JP00022
- Site JP00023
- Site JP00017
- Site JP00026
- Site JP00025
- Site JP00012
- Site JP00018
- Site JP00019
- Site JP00006
- Site JP00024
- Site JP00010
- Site JP00011
- Site JP00001
- Site JP00002
- Site JP00003
- Site JP00004
- Site JP00005
- Site JP00016
- Site JP00007
- Site JP00021
- Site JP00014
- Site JP00015
- Site JP00013
- Site JP00020
- Site JP00008
- Site JP00009
- Site JP00027
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ASP1707
Placebo
Arm Description
ASP1707 will be orally administered for 12 weeks.
Placebo will be orally administered for 12 weeks.
Outcomes
Primary Outcome Measures
ACR20 response rate
ACR20: American College of Rheumatology 20
Secondary Outcome Measures
ACR20 response rate
ACR50 response rate
ACR70 response rate
Change from baseline in DAS28-CRP score
DAS28-CRP: Disease Activity Score28 - C-reactive protein
Change from baseline in DAS28-ESR score
DAS28-ESR: Disease Activity Score28 - Erythrocyte sedimentation rate
Change from baseline in Tender Joint Count (68 joints)
Change from baseline in Swollen Joint Count (66 joints)
Percentage of subjects achieving DAS28-CRP score and DAS28-ESR score for remission (<2.6)
Percentage of subjects achieving DAS28-CRP score and DAS28-ESR score for low disease activity (≤3.2)
Change from baseline in CRP
Change from baseline in ESR
Percentage of subjects achieving EULAR response criterion of "Good Response"
EULAR: European league Against Rheumatism
Percentage of subjects achieving EULAR response criterion of "Good Response" or "Moderate Response"
Percentage of subjects achieving ACR/EULAR score for remission
Percentage of subjects achieving SDAI score ≦ 3.3 (SDAI remission)
SDAI: Simplified Disease Activity Index
Change from baseline in the SDAI score
Change from baseline for the HAQ-DI
HAQ-DI: Health Assessment Questionnaire - Disability Index
Safety assessed by incidence of adverse events
Safety assessed by body temperature
Safety assessed by pulse rate
Safety assessed by blood pressure in sitting position
Safety assessed by laboratory tests: Hematology
Safety assessed by laboratory tests: Biochemistry
Safety assessed by laboratory tests: Urinalysis
Safety assessed by standard 12-lead electrocardiogram
Safety assessed by weight
Plasma concentration of ASP1707
Plasma concentration of metabolite of ASP1707
Pharmacodynamics assessed by endocrinology tests
Pharmacodynamics assessed by plasma concentration of TNF-α
TNF: Tumor Necrosis Factor
Pharmacodynamics assessed by plasma concentration of MMP3
MMP3: Matrix metalloproteinase 3
Pharmacodynamics assessed by plasma concentration of IL-6
IL-6: Interleukin-6
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02884635
Brief Title
A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking Methotrexate
Official Title
Phase IIa Study of ASP1707 A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Phase 2a Study of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 16, 2016 (Actual)
Primary Completion Date
October 18, 2017 (Actual)
Study Completion Date
October 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Methotrexate, ASP1707, Rheumatoid arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASP1707
Arm Type
Experimental
Arm Description
ASP1707 will be orally administered for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be orally administered for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
ASP1707
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Methotrexate will be orally administered at stable dose from at least 28 days prior to screening through the screening and treatment periods until the end of the follow-up period.
Primary Outcome Measure Information:
Title
ACR20 response rate
Description
ACR20: American College of Rheumatology 20
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
ACR20 response rate
Time Frame
Up to Week 8
Title
ACR50 response rate
Time Frame
Up to Week 12
Title
ACR70 response rate
Time Frame
Up to Week 12
Title
Change from baseline in DAS28-CRP score
Description
DAS28-CRP: Disease Activity Score28 - C-reactive protein
Time Frame
Baseline and Up to Week 12
Title
Change from baseline in DAS28-ESR score
Description
DAS28-ESR: Disease Activity Score28 - Erythrocyte sedimentation rate
Time Frame
Baseline and Up to Week 12
Title
Change from baseline in Tender Joint Count (68 joints)
Time Frame
Baseline and Up to Week 12
Title
Change from baseline in Swollen Joint Count (66 joints)
Time Frame
Baseline and Up to Week 12
Title
Percentage of subjects achieving DAS28-CRP score and DAS28-ESR score for remission (<2.6)
Time Frame
Up to Week 12
Title
Percentage of subjects achieving DAS28-CRP score and DAS28-ESR score for low disease activity (≤3.2)
Time Frame
Up to Week 12
Title
Change from baseline in CRP
Time Frame
Baseline and Up to Week 12
Title
Change from baseline in ESR
Time Frame
Baseline and Up to Week 12
Title
Percentage of subjects achieving EULAR response criterion of "Good Response"
Description
EULAR: European league Against Rheumatism
Time Frame
Up to Week 12
Title
Percentage of subjects achieving EULAR response criterion of "Good Response" or "Moderate Response"
Time Frame
Up to Week 12
Title
Percentage of subjects achieving ACR/EULAR score for remission
Time Frame
Up to Week 12
Title
Percentage of subjects achieving SDAI score ≦ 3.3 (SDAI remission)
Description
SDAI: Simplified Disease Activity Index
Time Frame
Up to Week 12
Title
Change from baseline in the SDAI score
Time Frame
Baseline and Up to Week 12
Title
Change from baseline for the HAQ-DI
Description
HAQ-DI: Health Assessment Questionnaire - Disability Index
Time Frame
Baseline and Up to Week 12
Title
Safety assessed by incidence of adverse events
Time Frame
Up to Week 13
Title
Safety assessed by body temperature
Time Frame
Up to Week 13
Title
Safety assessed by pulse rate
Time Frame
Up to Week 13
Title
Safety assessed by blood pressure in sitting position
Time Frame
Up to Week 13
Title
Safety assessed by laboratory tests: Hematology
Time Frame
Up to Week 13
Title
Safety assessed by laboratory tests: Biochemistry
Time Frame
Up to Week 13
Title
Safety assessed by laboratory tests: Urinalysis
Time Frame
Up to Week 13
Title
Safety assessed by standard 12-lead electrocardiogram
Time Frame
Up to Week 13
Title
Safety assessed by weight
Time Frame
Up to Week 13
Title
Plasma concentration of ASP1707
Time Frame
Up to Week 12
Title
Plasma concentration of metabolite of ASP1707
Time Frame
Up to Week 12
Title
Pharmacodynamics assessed by endocrinology tests
Time Frame
Up to Week 13
Title
Pharmacodynamics assessed by plasma concentration of TNF-α
Description
TNF: Tumor Necrosis Factor
Time Frame
Up to Week 13
Title
Pharmacodynamics assessed by plasma concentration of MMP3
Description
MMP3: Matrix metalloproteinase 3
Time Frame
Up to Week 13
Title
Pharmacodynamics assessed by plasma concentration of IL-6
Description
IL-6: Interleukin-6
Time Frame
Up to Week 13
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has RA that was diagnosed according to the 1987 ACR criteria or the 2010 ACR/EULAR criteria.
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.
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.
Exclusion Criteria:
Inadequate responders to a biologic DMARD (Disease-modifying antirheumatic drug).
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.
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.
Subject has another type of inflammatory arthritis other than RA.
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
Subject has a positive QuantiFERON-TB Gold test or T-spot.
Subject has a history of or concurrent malignant tumor.
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.
Subject has a history of clinically significant allergy.
Subject has clinically significant abnormalities on the 12-lead Electrocardiogram.
Subject has a history of positive Human Immunodeficiency Virus infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
Facility Name
Site JP00022
City
Aichi
Country
Japan
Facility Name
Site JP00023
City
Aichi
Country
Japan
Facility Name
Site JP00017
City
Chiba
Country
Japan
Facility Name
Site JP00026
City
Ehime
Country
Japan
Facility Name
Site JP00025
City
Fukui
Country
Japan
Facility Name
Site JP00012
City
Fukuoka
Country
Japan
Facility Name
Site JP00018
City
Fukuoka
Country
Japan
Facility Name
Site JP00019
City
Fukuoka
Country
Japan
Facility Name
Site JP00006
City
Gunma
Country
Japan
Facility Name
Site JP00024
City
Gunma
Country
Japan
Facility Name
Site JP00010
City
Hiroshima
Country
Japan
Facility Name
Site JP00011
City
Hiroshima
Country
Japan
Facility Name
Site JP00001
City
Hokkaido
Country
Japan
Facility Name
Site JP00002
City
Hokkaido
Country
Japan
Facility Name
Site JP00003
City
Hokkaido
Country
Japan
Facility Name
Site JP00004
City
Iwate
Country
Japan
Facility Name
Site JP00005
City
Iwate
Country
Japan
Facility Name
Site JP00016
City
Kagoshima
Country
Japan
Facility Name
Site JP00007
City
Kanagawa
Country
Japan
Facility Name
Site JP00021
City
Kanagawa
Country
Japan
Facility Name
Site JP00014
City
Kumamoto
Country
Japan
Facility Name
Site JP00015
City
Kumamoto
Country
Japan
Facility Name
Site JP00013
City
Nagasaki
Country
Japan
Facility Name
Site JP00020
City
Oita
Country
Japan
Facility Name
Site JP00008
City
Shizuoka
Country
Japan
Facility Name
Site JP00009
City
Shizuoka
Country
Japan
Facility Name
Site JP00027
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD Sharing Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing
IPD Sharing URL
https://www.clinicalstudydatarequest.com
Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/findresult.aspx?RID=;;;1707-CL-3001;;;
Description
Link to results on the Astellas Clinical Study Results website
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking Methotrexate
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