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Completed

NCT Number: NCT02884635

A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking Methotrexate

The objective of this study is to evaluate the efficacy, pharmacokinetics, pharmacodynamics and safety of ASP1707 in combination with MTX in postmenopausal female patients with RA.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Site JP00004, Numakunai, Iwate, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject has RA that was diagnosed according to the 1987 ACR criteria or the 2010 ACR/EULAR criteria.
  • Subject meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III.
  • subject has active RA as evidenced by both of the followings:
  • ≥ 6 tender/painful joints (using 68-joint assessment)
  • ≥ 6 swollen joints (using 66-joint assessment)
  • CRP (C-reactive protein) of > 0.3 mg/dL or ESR (Erythrocyte sedimentation rate) of > 28 mm/hr at screening.
  • Subject who continuously received MTX and who is able to continue stable dose of MTX.
  • Subject who did not receive the following drugs, or received the drugs with stable dosage:

Non-steroidal anti-inflammatory drugs, oral morphine or equivalent opioid analgesics, acetaminophen, or oral corticosteroids.

Exclusion criteria

  • Inadequate responders to a biologic DMARD (Disease-modifying antirheumatic drug).
  • Subject has taken other investigational research products are prohibited within 12 weeks (84 days) or within 5 half-lives, whichever is longer, prior to screening.
  • Subject has undergone surgery which has residual effects on the assessed joints, or is scheduled to undergo surgery that may affect the study evaluation of the assessed joints.
  • Subject has another type of inflammatory arthritis other than RA.
  • Subject who meets any of the following criteria of laboratory values at screening:
  • White blood cell count <4000/μL
  • Platelet count <100000/μL
  • ALT (Alanine Aminotransferase) ≥ 2 x ULN (Upper Limit of Normal)
  • AST (Aspartate Aminotransferase) ≥ 2 x ULN
  • Total bilirubin ≥ 1.5 x ULN
  • Positive Hepatitis B surface antigen, Hepatitis B virus-DNA quantitation, or Hepatitis C virus antibody
  • Subject has a positive QuantiFERON-TB Gold test or T-spot.
  • Subject has a history of or concurrent malignant tumor.
  • Subject has any ongoing severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, infectious, or autoimmune disease except for RA, or diseases which preclude the subject's participation in the study.
  • Subject has a history of clinically significant allergy.
  • Subject has clinically significant abnormalities on the 12-lead Electrocardiogram.
  • Subject has a history of positive Human Immunodeficiency Virus infection.

Treatment and study plan

ASP1707

Drug

Oral

Placebo

Drug

Oral

methotrexate

Drug

Methotrexate will be orally administered at stable dose from at least 28 days prior to screening through the screening and treatment periods until the end of the follow-up period.

Primary outcomes

  1. ACR20 response rate

    Time frame: Week 12

    ACR20: American College of Rheumatology 20

Secondary outcomes

  1. ACR20 response rate

    Time frame: Up to Week 8

  2. ACR50 response rate

    Time frame: Up to Week 12

  3. ACR70 response rate

    Time frame: Up to Week 12

  4. Change from baseline in DAS28-CRP score

    Time frame: Baseline and Up to Week 12

    DAS28-CRP: Disease Activity Score28 - C-reactive protein

  5. Change from baseline in DAS28-ESR score

    Time frame: Baseline and Up to Week 12

    DAS28-ESR: Disease Activity Score28 - Erythrocyte sedimentation rate

  6. Change from baseline in Tender Joint Count (68 joints)

    Time frame: Baseline and Up to Week 12

  7. Change from baseline in Swollen Joint Count (66 joints)

    Time frame: Baseline and Up to Week 12

  8. Percentage of subjects achieving DAS28-CRP score and DAS28-ESR score for remission (<2.6)

    Time frame: Up to Week 12

  9. Percentage of subjects achieving DAS28-CRP score and DAS28-ESR score for low disease activity (≤3.2)

    Time frame: Up to Week 12

  10. Change from baseline in CRP

    Time frame: Baseline and Up to Week 12

  11. Change from baseline in ESR

    Time frame: Baseline and Up to Week 12

  12. Percentage of subjects achieving EULAR response criterion of "Good Response"

    Time frame: Up to Week 12

    EULAR: European league Against Rheumatism

  13. Percentage of subjects achieving EULAR response criterion of "Good Response" or "Moderate Response"

    Time frame: Up to Week 12

  14. Percentage of subjects achieving ACR/EULAR score for remission

    Time frame: Up to Week 12

  15. Percentage of subjects achieving SDAI score ≦ 3.3 (SDAI remission)

    Time frame: Up to Week 12

    SDAI: Simplified Disease Activity Index

  16. Change from baseline in the SDAI score

    Time frame: Baseline and Up to Week 12

  17. Change from baseline for the HAQ-DI

    Time frame: Baseline and Up to Week 12

    HAQ-DI: Health Assessment Questionnaire - Disability Index

  18. Safety assessed by incidence of adverse events

    Time frame: Up to Week 13

  19. Safety assessed by body temperature

    Time frame: Up to Week 13

  20. Safety assessed by pulse rate

    Time frame: Up to Week 13

  21. Safety assessed by blood pressure in sitting position

    Time frame: Up to Week 13

  22. Safety assessed by laboratory tests: Hematology

    Time frame: Up to Week 13

  23. Safety assessed by laboratory tests: Biochemistry

    Time frame: Up to Week 13

  24. Safety assessed by laboratory tests: Urinalysis

    Time frame: Up to Week 13

  25. Safety assessed by standard 12-lead electrocardiogram

    Time frame: Up to Week 13

  26. Safety assessed by weight

    Time frame: Up to Week 13

  27. Plasma concentration of ASP1707

    Time frame: Up to Week 12

  28. Plasma concentration of metabolite of ASP1707

    Time frame: Up to Week 12

  29. Pharmacodynamics assessed by endocrinology tests

    Time frame: Up to Week 13

  30. Pharmacodynamics assessed by plasma concentration of TNF-α

    Time frame: Up to Week 13

    TNF: Tumor Necrosis Factor

  31. Pharmacodynamics assessed by plasma concentration of MMP3

    Time frame: Up to Week 13

    MMP3: Matrix metalloproteinase 3

  32. Pharmacodynamics assessed by plasma concentration of IL-6

    Time frame: Up to Week 13

    IL-6: Interleukin-6

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Phase IIa Study of ASP1707 A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Phase 2a Study of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 31, 2016
Registry last updated
Oct 23, 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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