A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate
A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate
1 other identifier
interventional
66
1 country
31
Brief Summary
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP5094 in patients with rheumatoid arthritis (RA) treated with background methotrexate (MTX).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2017
Shorter than P25 for phase_2
31 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 20, 2017
CompletedFirst Posted
Study publicly available on registry
August 22, 2017
CompletedStudy Start
First participant enrolled
September 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2018
CompletedOctober 31, 2024
October 1, 2024
12 months
August 20, 2017
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ACR50 response rate
To assess ACR (American College of Rheumatology) 50 for efficacy
Week 12
Secondary Outcomes (33)
ACR50 response rate
Up to Week 16
ACR20 response rate
Up to Week 16
ACR70 response rate
Up to Week 16
Change from baseline in DAS28-CRP score
Baseline and Up to Week 16
Change from baseline in DAS28-ESR score
Baseline and Up to Week 16
- +28 more secondary outcomes
Study Arms (2)
ASP5094 Group
EXPERIMENTALTo be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
Placebo Group
PLACEBO COMPARATORTo be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
Interventions
MTX must have been continuously orally administered for at least 90 days prior to screening, with stable dosage for at least 28 days prior to screening, and will be continuously administered with the same dosage throughout the study period.
Eligibility Criteria
You may qualify if:
- Subject has RA diagnosed according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism (EULAR) criteria at least 6 months prior to screening.
- Subject meets the 1991 ACR Revised Criteria for the Classification of Global Functional Status in RA Class I, II, or III at screening.
- At screening and baseline, subject has active RA as evidenced by both of the following:
- ≥ 6 tender/painful joints (using 68-joint assessment)
- ≥ 6 swollen joints (using 66-joint assessment)
- Subject meets the criterion for a CRP level (Latex Agglutination method) at screening.
- Subject who has continuously received Methotrexate for at least 90 days prior to screening and who is able to continue a stable dose of Methotrexate from at least 28 days prior to screening throughout the study period.
You may not qualify if:
- Subject has deviated from the criteria for previous and concomitant treatment before baseline.
- Subject has an ongoing infection requiring antibiotics.
- Subject is determined to be an inadequate responder to a prior biologic disease modifying antirheumatic drugs (DMARDs) or Janus kinase (JAK) inhibitors.
- Subject has participated in previous ASP5094 clinical trial.
- Subject has participated in a clinical trial or post-marketing clinical study of another ethical drug or medical device within 12 weeks (84 days).
- Subject has another inflammatory arthritis than RA, or any other articular symptom which may affect on joint assessment.
- Subject meets any of the criteria for laboratory values at screening.
- Subject has a positive T-SPOT or QuantiFERON Gold test within 90 days prior to screening or at screening.
- Subject has a history of or concurrent malignant tumor.
- Subject has autoimmune disease except for RA or any severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, or mental illness.
- Subject has a history of clinically significant allergy.
- Subject has clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening.
- Subject has a history of Human Immunodeficiency Virus (HIV) infection.
- Subject had surgery within 30 days prior to screening or has a planned elective surgery.
- Subject has a wound that is currently healing at baseline.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Site JP00002
Asahikawa, Japan
Site JP00027
Asahikawa, Japan
Site JP00029
Beppu, Japan
Site JP00015
Chiba, Japan
Site JP00008
Fukuoka, Japan
Site JP00009
Fukuoka, Japan
Site JP00026
Fukuoka, Japan
Site JP00016
Ichinomiya, Japan
Site JP00012
Kanuma, Japan
Site JP00028
Kawachi-Nagano, Japan
Site JP00005
Kitamoto, Japan
Site JP00025
Kobe, Japan
Site JP00030
Kobe, Japan
Site JP00010
Kumamoto, Japan
Site JP00006
Kyoto, Japan
Site JP00018
Meguro City, Japan
Site JP00020
Nagano, Japan
Site JP00014
Nagoya, Japan
Site JP00022
Okayama, Japan
Site JP00011
Ōita, Japan
Site JP00003
Ōsaki, Japan
Site JP00019
Sagamihara, Japan
Site JP00007
Sanuki, Japan
Site JP00001
Sapporo, Japan
Site JP00023
Shimonoseki, Japan
Site JP00021
Shizuoka, Japan
Site JP00004
Takasaki, Japan
Site JP00017
Tomakomai, Japan
Site JP00013
Toyohashi, Japan
Site JP00024
Tsukuba, Japan
Site JP00031
Yokohama, Japan
Related Publications (1)
Takeuchi T, Tanaka Y, Erdman J, Kaneko Y, Saito M, Higashitani C, Smulders R, Lademacher C. ASP5094, a humanized monoclonal antibody against integrin alpha-9, did not show efficacy in patients with rheumatoid arthritis refractory to methotrexate: results from a phase 2a, randomized, double-blind, placebo-controlled trial. Arthritis Res Ther. 2020 Oct 21;22(1):252. doi: 10.1186/s13075-020-02336-3.
PMID: 33087159DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2017
First Posted
August 22, 2017
Study Start
September 29, 2017
Primary Completion
September 19, 2018
Study Completion
October 16, 2018
Last Updated
October 31, 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 Agreement.
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/.