A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking Methotrexate
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)
1 other identifier
interventional
72
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started Sep 2016
Shorter than P25 for phase_2 rheumatoid-arthritis
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2016
CompletedFirst Posted
Study publicly available on registry
August 31, 2016
CompletedStudy Start
First participant enrolled
September 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2017
CompletedOctober 23, 2024
October 1, 2024
1.1 years
August 26, 2016
October 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ACR20 response rate
ACR20: American College of Rheumatology 20
Week 12
Secondary Outcomes (32)
ACR20 response rate
Up to Week 8
ACR50 response rate
Up to Week 12
ACR70 response rate
Up to Week 12
Change from baseline in DAS28-CRP score
Baseline and Up to Week 12
Change from baseline in DAS28-ESR score
Baseline and Up to Week 12
- +27 more secondary outcomes
Study Arms (2)
ASP1707
EXPERIMENTALASP1707 will be orally administered for 12 weeks.
Placebo
PLACEBO COMPARATORPlacebo will be orally administered for 12 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Site JP00004
Numakunai, Iwate, Japan
Site JP00005
Numakunai, Iwate, Japan
Site JP00022
Aichi, Japan
Site JP00023
Aichi, Japan
Site JP00017
Chiba, Japan
Site JP00026
Ehime, Japan
Site JP00025
Fukui, Japan
Site JP00012
Fukuoka, Japan
Site JP00018
Fukuoka, Japan
Site JP00019
Fukuoka, Japan
Site JP00006
Gunma, Japan
Site JP00024
Gunma, Japan
Site JP00010
Hiroshima, Japan
Site JP00011
Hiroshima, Japan
Site JP00001
Hokkaido, Japan
Site JP00002
Hokkaido, Japan
Site JP00003
Hokkaido, Japan
Site JP00016
Kagoshima, Japan
Site JP00007
Kanagawa, Japan
Site JP00021
Kanagawa, Japan
Site JP00014
Kumamoto, Japan
Site JP00015
Kumamoto, Japan
Site JP00013
Nagasaki, Japan
Site JP00020
Ōita, Japan
Site JP00008
Shizuoka, Japan
Site JP00009
Shizuoka, Japan
Site JP00027
Tokyo, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2016
First Posted
August 31, 2016
Study Start
September 16, 2016
Primary Completion
October 18, 2017
Study Completion
October 25, 2017
Last Updated
October 23, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.