A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate

October 29, 2024 updated by: Astellas Pharma Inc

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study drug will be intravenously administered.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Asahikawa, Japan
        • Site JP00002
      • Asahikawa, Japan
        • Site JP00027
      • Beppu, Japan
        • Site JP00029
      • Chiba, Japan
        • Site JP00015
      • Fukuoka, Japan
        • Site JP00008
      • Fukuoka, Japan
        • Site JP00009
      • Fukuoka, Japan
        • Site JP00026
      • Ichinomiya, Japan
        • Site JP00016
      • Kanuma, Japan
        • Site JP00012
      • Kawachinagano, Japan
        • Site JP00028
      • Kitamoto, Japan
        • Site JP00005
      • Kobe, Japan
        • Site JP00025
      • Kobe, Japan
        • Site JP00030
      • Kumamoto, Japan
        • Site JP00010
      • Kyoto, Japan
        • Site JP00006
      • Meguro, Japan
        • Site JP00018
      • Nagano, Japan
        • Site JP00020
      • Nagoya, Japan
        • Site JP00014
      • Oita, Japan
        • Site JP00011
      • Okayama, Japan
        • Site JP00022
      • Osaki, Japan
        • Site JP00003
      • Sagamihara, Japan
        • Site JP00019
      • Sanuki, Japan
        • Site JP00007
      • Sapporo, Japan
        • Site JP00001
      • Shimonoseki, Japan
        • Site JP00023
      • Shizuoka, Japan
        • Site JP00021
      • Takasaki, Japan
        • Site JP00004
      • Tomakomai, Japan
        • Site JP00017
      • Toyohashi, Japan
        • Site JP00013
      • Tsukuba, Japan
        • Site JP00024
      • Yokohama, Japan
        • Site JP00031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ASP5094 Group
To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
Drug: ASP5094
intravenously administration
Other: 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 Comparator: Placebo Group
To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
Other: 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.
Drug: Placebo
intravenously administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ACR50 response rate
Time Frame: Week 12
To assess ACR (American College of Rheumatology) 50 for efficacy
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ACR50 response rate
Time Frame: Up to Week 16
To assess ACR (American College of Rheumatology) 50 for efficacy
Up to Week 16
ACR20 response rate
Time Frame: Up to Week 16
To assess ACR (American College of Rheumatology) 20 for efficacy
Up to Week 16
ACR70 response rate
Time Frame: Up to Week 16
To assess ACR (American College of Rheumatology) 70 for efficacy
Up to Week 16
Change from baseline in DAS28-CRP score
Time Frame: Baseline and Up to Week 16
To assess DAS28-CRP (Disease Activity Score28 - C-reactive protein) for efficacy
Baseline and Up to Week 16
Change from baseline in DAS28-ESR score
Time Frame: Baseline and Up to Week 16
To assess DAS28-ESR (Disease Activity Score28 - Erythrocyte sedimentation rate) for efficacy
Baseline and Up to Week 16
Change from baseline in Tender Joint Count (68 joints)
Time Frame: Baseline and Up to Week 16
To assess Tender Joint Count for efficacy
Baseline and Up to Week 16
Change from baseline in Swollen Joint Count (66 joints)
Time Frame: Baseline and Up to Week 16
To assess Swollen Joint Count for efficacy
Baseline and Up to Week 16
Percentage of subjects achieving DAS28-CRP score for remission (<2.6)
Time Frame: Up to Week 16
To assess DAS28-CRP score for efficacy
Up to Week 16
Percentage of subjects achieving DAS28-ESR score for remission (<2.6)
Time Frame: Up to Week 16
To assess DAS28-ESR score for efficacy
Up to Week 16
Percentage of subjects achieving DAS28-CRP score for low disease activity (≦3.2)
Time Frame: Up to Week 16
To assess DAS28-CRP score for efficacy
Up to Week 16
Percentage of subjects achieving DAS28-ESR score for low disease activity (≦3.2)
Time Frame: Up to Week 16
To assess DAS28-ESR score for efficacy
Up to Week 16
Change from baseline in CRP
Time Frame: Baseline and Up to Week 16
To assess CRP (C-reactive protein) for efficacy
Baseline and Up to Week 16
Change from baseline in ESR
Time Frame: Baseline and Up to Week 16
To assess ESR (Erythrocyte sedimentation rate) for efficacy
Baseline and Up to Week 16
Percentage of subjects achieving EULAR response criteria of "Good Response"
Time Frame: Up to Week 16
To assess EULAR (European league Against Rheumatism) response criteria for efficacy
Up to Week 16
Percentage of subjects achieving EULAR response criteria of "Good Response" or "Moderate Response"
Time Frame: Up to Week 16
To assess EULAR response criteria for efficacy
Up to Week 16
Percentage of subjects achieving ACR/EULAR score for remission
Time Frame: Up to Week 16
To assess ACR/EULAR remission for efficacy
Up to Week 16
Percentage of subjects achieving SDAI score ≦ 3.3 (SDAI remission)
Time Frame: Up to Week 16
To assess SDAI (Simplified Disease Activity Index) score for efficacy
Up to Week 16
Percentage of subjects achieving CDAI score ≦ 2.8 (CDAI remission)
Time Frame: Up to Week 16
To assess CDAI (Clinical Disease Activity Index) score for efficacy
Up to Week 16
Change from baseline for the HAQ-DI
Time Frame: Baseline to Up to Week 16
To assess HAQ-DI (Health Assessment Questionnaire - Disability Index) for efficacy
Baseline to Up to Week 16
Safety assessed by incidence of adverse events
Time Frame: Up to Week 16
Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Up to Week 16
Safety assessed by laboratory tests: Hematology
Time Frame: Up to Week 16
To assess hematology as a criteria of safety variables.
Up to Week 16
Safety assessed by laboratory tests: Biochemistry
Time Frame: Up to Week 16
To assess Biochemistry as a criteria of safety variables.
Up to Week 16
Safety assessed by laboratory tests: Urinalysis
Time Frame: Up to Week 16
To assess Urinalysis as a criteria of safety variables.
Up to Week 16
Safety assessed by vital signs: Body temperature
Time Frame: Up to Week 16
To assess the vital sign as a criteria of safety variables.
Up to Week 16
Safety assessed by vital signs: Sitting blood pressure
Time Frame: Up to Week 16
To assess the vital sign as a criteria of safety variables.
Up to Week 16
Safety assessed by vital signs: pulse rate
Time Frame: Up to Week 16
To assess the vital sign as a criteria of safety variables.
Up to Week 16
Safety assessed by weight
Time Frame: Up to Week 16
To assess the weight as a criteria of safety variables.
Up to Week 16
Safety assessed by standard 12-lead electrocardiogram
Time Frame: Up to Week 16
To assess the cardiovascular system functioning as a criteria of safety variables.
Up to Week 16
Serum concentration of ASP5094
Time Frame: Up to Week 16
To assess Serum concentration of ASP5094 for pharmacokinetics
Up to Week 16
Serum concentration of TNF-α
Time Frame: Up to Week 16
To assess TNF-α (Tumor Necrosis Factor-α) for pharmacodynamics
Up to Week 16
Serum concentration of MMP3
Time Frame: Up to Week 16
To assess MMP3 (Matrix metalloproteinase 3) for pharmacodynamics
Up to Week 16
Serum concentration of IL-6
Time Frame: Up to Week 16
To assess IL-6 (Interleukin-6) for pharmacodynamics
Up to Week 16
Anti-ASP5094 anti-bodies
Time Frame: Up to Week 16
To assess Anti-ASP5094 anti-bodies for immunogenicity
Up to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 19, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5094-CL-0201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/.

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 Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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