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Rheumatoid ArthritisPhase 2NCT02884635

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

A Phase 2 study testing ASP1707 and Methotrexate in people with Rheumatoid Arthritis, run by Astellas Pharma Inc at 27 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
ASP1707 and Methotrexate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
27 sitesJapan
Study dates
16 Sep 2016to 25 Oct 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Japan27 sites

  • Site JP00022

    Aichi

  • Site JP00023

    Aichi

  • Site JP00017

    Chiba

  • Site JP00026

    Ehime

  • Site JP00025

    Fukui

  • Site JP00012

    Fukuoka

  • Site JP00018

    Fukuoka

  • Site JP00019

    Fukuoka

  • Site JP00006

    Gunma

  • Site JP00024

    Gunma

  • Site JP00010

    Hiroshima

  • Site JP00011

    Hiroshima

  • Site JP00001

    Hokkaido

  • Site JP00002

    Hokkaido

  • Site JP00003

    Hokkaido

  • Site JP00016

    Kagoshima

  • Site JP00007

    Kanagawa

  • Site JP00021

    Kanagawa

  • Site JP00014

    Kumamoto

  • Site JP00015

    Kumamoto

  • Site JP00013

    Nagasaki

  • Site JP00004

    Numakunai, Iwate

  • Site JP00005

    Numakunai, Iwate

  • Site JP00020

    Ōita

  • Site JP00008

    Shizuoka

  • Site JP00009

    Shizuoka

  • Site JP00027

    Tokyo

Other trials in Japan

About this study

Official 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)

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.

Being tested
ASP1707, Placebo, Methotrexate
Keywords
Methotrexate, ASP1707, Rheumatoid arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASP1707Drug

    Oral

  • PlaceboDrug

    Oral

  • MethotrexateDrug

    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.

Study groups in NCT02884635
Study groupRoleWhat they receive
ASP1707ExperimentalASP1707 will be orally administered for 12 weeks.
Receives: Drug: ASP1707; Drug: Methotrexate
PlaceboPlacebo comparatorPlacebo will be orally administered for 12 weeks.
Receives: Drug: Placebo; Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ACR20 response rate

    ACR20: American College of Rheumatology 20

    Measured: Week 12

Secondary outcomes (32)

  1. ACR20 response rate

    Measured: Up to Week 8

  2. ACR50 response rate

    Measured: Up to Week 12

  3. ACR70 response rate

    Measured: Up to Week 12

  4. Change from baseline in DAS28-CRP score

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

    Measured: Baseline and Up to Week 12

  5. Change from baseline in DAS28-ESR score

    DAS28-ESR: Disease Activity Score28 - Erythrocyte sedimentation rate

    Measured: Baseline and Up to Week 12

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

    Measured: Baseline and Up to Week 12

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

    Measured: Baseline and Up to Week 12

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

    Measured: Up to Week 12

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

    Measured: Up to Week 12

  10. Change from baseline in CRP

    Measured: Baseline and Up to Week 12

  11. Change from baseline in ESR

    Measured: Baseline and Up to Week 12

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

    EULAR: European league Against Rheumatism

    Measured: Up to Week 12

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

    Measured: Up to Week 12

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

    Measured: Up to Week 12

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

    SDAI: Simplified Disease Activity Index

    Measured: Up to Week 12

  16. Change from baseline in the SDAI score

    Measured: Baseline and Up to Week 12

  17. Change from baseline for the HAQ-DI

    HAQ-DI: Health Assessment Questionnaire - Disability Index

    Measured: Baseline and Up to Week 12

  18. Safety assessed by incidence of adverse events

    Measured: Up to Week 13

  19. Safety assessed by body temperature

    Measured: Up to Week 13

  20. Safety assessed by pulse rate

    Measured: Up to Week 13

  21. Safety assessed by blood pressure in sitting position

    Measured: Up to Week 13

  22. Safety assessed by laboratory tests: Hematology

    Measured: Up to Week 13

  23. Safety assessed by laboratory tests: Biochemistry

    Measured: Up to Week 13

  24. Safety assessed by laboratory tests: Urinalysis

    Measured: Up to Week 13

  25. Safety assessed by standard 12-lead electrocardiogram

    Measured: Up to Week 13

  26. Safety assessed by weight

    Measured: Up to Week 13

  27. Plasma concentration of ASP1707

    Measured: Up to Week 12

  28. Plasma concentration of metabolite of ASP1707

    Measured: Up to Week 12

  29. Pharmacodynamics assessed by endocrinology tests

    Measured: Up to Week 13

  30. Pharmacodynamics assessed by plasma concentration of TNF-α

    TNF: Tumor Necrosis Factor

    Measured: Up to Week 13

  31. Pharmacodynamics assessed by plasma concentration of MMP3

    MMP3: Matrix metalloproteinase 3

    Measured: Up to Week 13

  32. Pharmacodynamics assessed by plasma concentration of IL-6

    IL-6: Interleukin-6

    Measured: Up to Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2016 (estimated)
  2. Study start16 Sep 2016
  3. Primary completion18 Oct 2017
  4. Study completion25 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02884635
Sponsor's protocol ID
1707-CL-3001
Status last verified
Oct 2024
First submitted
26 Aug 2016
Last updated
23 Oct 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASP1707 and Methotrexate in people with Rheumatoid Arthritis, run by Astellas Pharma Inc at 27 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACR20 response rate (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02884635.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.

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