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

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ClinicalTrials.gov Identifier: NCT03257852
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis (RA) Drug: ASP5094 Drug: Placebo Other: Methotrexate therapy Phase 2

Detailed Description:
The study drug will be intravenously administered.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 29, 2017
Actual Primary Completion Date : September 19, 2018
Actual Study Completion Date : October 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Placebo
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.




Primary Outcome Measures :
  1. ACR50 response rate [ Time Frame: Week 12 ]
    To assess ACR (American College of Rheumatology) 50 for efficacy


Secondary Outcome Measures :
  1. ACR50 response rate [ Time Frame: Up to Week 16 ]
    To assess ACR (American College of Rheumatology) 50 for efficacy

  2. ACR20 response rate [ Time Frame: Up to Week 16 ]
    To assess ACR (American College of Rheumatology) 20 for efficacy

  3. ACR70 response rate [ Time Frame: Up to Week 16 ]
    To assess ACR (American College of Rheumatology) 70 for efficacy

  4. 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

  5. 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

  6. Change from baseline in Tender Joint Count (68 joints) [ Time Frame: Baseline and Up to Week 16 ]
    To assess Tender Joint Count for efficacy

  7. Change from baseline in Swollen Joint Count (66 joints) [ Time Frame: Baseline and Up to Week 16 ]
    To assess Swollen Joint Count for efficacy

  8. Percentage of subjects achieving DAS28-CRP score for remission (<2.6) [ Time Frame: Up to Week 16 ]
    To assess DAS28-CRP score for efficacy

  9. Percentage of subjects achieving DAS28-ESR score for remission (<2.6) [ Time Frame: Up to Week 16 ]
    To assess DAS28-ESR score for efficacy

  10. 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

  11. 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

  12. Change from baseline in CRP [ Time Frame: Baseline and Up to Week 16 ]
    To assess CRP (C-reactive protein) for efficacy

  13. Change from baseline in ESR [ Time Frame: Baseline and Up to Week 16 ]
    To assess ESR (Erythrocyte sedimentation rate) for efficacy

  14. 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

  15. 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

  16. Percentage of subjects achieving ACR/EULAR score for remission [ Time Frame: Up to Week 16 ]
    To assess ACR/EULAR remission for efficacy

  17. 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

  18. 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

  19. 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

  20. 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).

  21. Safety assessed by laboratory tests: Hematology [ Time Frame: Up to Week 16 ]
    To assess hematology as a criteria of safety variables.

  22. Safety assessed by laboratory tests: Biochemistry [ Time Frame: Up to Week 16 ]
    To assess Biochemistry as a criteria of safety variables.

  23. Safety assessed by laboratory tests: Urinalysis [ Time Frame: Up to Week 16 ]
    To assess Urinalysis as a criteria of safety variables.

  24. Safety assessed by vital signs: Body temperature [ Time Frame: Up to Week 16 ]
    To assess the vital sign as a criteria of safety variables.

  25. 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.

  26. Safety assessed by vital signs: pulse rate [ Time Frame: Up to Week 16 ]
    To assess the vital sign as a criteria of safety variables.

  27. Safety assessed by weight [ Time Frame: Up to Week 16 ]
    To assess the weight as a criteria of safety variables.

  28. 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.

  29. Serum concentration of ASP5094 [ Time Frame: Up to Week 16 ]
    To assess Serum concentration of ASP5094 for pharmacokinetics

  30. Serum concentration of TNF-α [ Time Frame: Up to Week 16 ]
    To assess TNF-α (Tumor Necrosis Factor-α) for pharmacodynamics

  31. Serum concentration of MMP3 [ Time Frame: Up to Week 16 ]
    To assess MMP3 (Matrix metalloproteinase 3) for pharmacodynamics

  32. Serum concentration of IL-6 [ Time Frame: Up to Week 16 ]
    To assess IL-6 (Interleukin-6) for pharmacodynamics

  33. Anti-ASP5094 anti-bodies [ Time Frame: Up to Week 16 ]
    To assess Anti-ASP5094 anti-bodies for immunogenicity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257852


Locations
Show Show 31 study locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT03257852    
Other Study ID Numbers: 5094-CL-0201
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc:
Methotrexate
Arthritis, Rheumatoid
ASP5094
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors