A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate
NCT ID: NCT03257852
Last Updated: 2024-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2017-09-29
2018-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ASP5094 Group
To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
ASP5094
intravenously administration
Methotrexate therapy
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.
Placebo Group
To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
Placebo
intravenously administration
Methotrexate therapy
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.
Interventions
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ASP5094
intravenously administration
Placebo
intravenously administration
Methotrexate therapy
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
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
20 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Inc
Locations
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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
Countries
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References
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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.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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5094-CL-0201
Identifier Type: -
Identifier Source: org_study_id
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