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Completed

NCT Number: NCT03257852

A 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).

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Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site JP00002, Asahikawa, Japan

Loading trial locations.

About this study

The study drug will be intravenously administered.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASP5094

Drug

intravenously administration

Placebo

Drug

intravenously administration

Methotrexate therapy

Other

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 outcomes

  1. ACR50 response rate

    Time frame: Week 12

    To assess ACR (American College of Rheumatology) 50 for efficacy

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2017
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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