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Rheumatoid Arthritis (RA)Phase 2NCT03257852

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

A Phase 2 study testing ASP5094 and Methotrexate therapy in people with Rheumatoid Arthritis (RA), run by Astellas Pharma Inc at 31 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, safety and pharmacokinetics of ASP5094 in patients with rheumatoid arthritis (RA) treated with background methotrexate (MTX). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Rheumatoid Arthritis (RA)
What is being tested?
ASP5094 and Methotrexate therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
31 sitesJapan
Study dates
29 Sep 2017to 16 Oct 2018
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

Japan31 sites

  • Site JP00002

    Asahikawa

  • Site JP00027

    Asahikawa

  • Site JP00029

    Beppu

  • Site JP00015

    Chiba

  • Site JP00008

    Fukuoka

  • Site JP00009

    Fukuoka

  • Site JP00026

    Fukuoka

  • Site JP00016

    Ichinomiya

  • Site JP00012

    Kanuma

  • Site JP00028

    Kawachi-Nagano

  • Site JP00005

    Kitamoto

  • Site JP00025

    Kobe

  • Site JP00030

    Kobe

  • Site JP00010

    Kumamoto

  • Site JP00006

    Kyoto

  • Site JP00018

    Meguro City

  • Site JP00020

    Nagano

  • Site JP00014

    Nagoya

  • Site JP00011

    Ōita

  • Site JP00022

    Okayama

  • Site JP00003

    Ōsaki

  • Site JP00019

    Sagamihara

  • Site JP00007

    Sanuki

  • Site JP00001

    Sapporo

  • Site JP00023

    Shimonoseki

  • Site JP00021

    Shizuoka

  • Site JP00004

    Takasaki

  • Site JP00017

    Tomakomai

  • Site JP00013

    Toyohashi

  • Site JP00024

    Tsukuba

  • Site JP00031

    Yokohama

Other trials in Japan

About this study

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

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).

Read the detailed description

The study drug will be intravenously administered.

Being tested
ASP5094, Placebo, Methotrexate therapy
Keywords
Methotrexate, Arthritis, Rheumatoid, ASP5094
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • ASP5094Drug

    intravenously administration

  • PlaceboDrug

    intravenously administration

  • Methotrexate therapyOther

    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.

Study groups in NCT03257852
Study groupRoleWhat they receive
ASP5094 GroupExperimentalTo be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
Receives: Drug: ASP5094; Other: Methotrexate therapy
Placebo GroupPlacebo comparatorTo be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
Receives: Drug: Placebo; Other: Methotrexate therapy

What is being measured

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

  1. ACR50 response rate

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

    Measured: Week 12

Secondary outcomes (33)

  1. ACR50 response rate

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

    Measured: Up to Week 16

  2. ACR20 response rate

    To assess ACR (American College of Rheumatology) 20 for efficacy

    Measured: Up to Week 16

  3. ACR70 response rate

    To assess ACR (American College of Rheumatology) 70 for efficacy

    Measured: Up to Week 16

  4. Change from baseline in DAS28-CRP score

    To assess DAS28-CRP (Disease Activity Score28 - C-reactive protein) for efficacy

    Measured: Baseline and Up to Week 16

  5. Change from baseline in DAS28-ESR score

    To assess DAS28-ESR (Disease Activity Score28 - Erythrocyte sedimentation rate) for efficacy

    Measured: Baseline and Up to Week 16

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

    To assess Tender Joint Count for efficacy

    Measured: Baseline and Up to Week 16

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

    To assess Swollen Joint Count for efficacy

    Measured: Baseline and Up to Week 16

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

    To assess DAS28-CRP score for efficacy

    Measured: Up to Week 16

  9. Percentage of subjects achieving DAS28-ESR score for remission (<2.6)

    To assess DAS28-ESR score for efficacy

    Measured: Up to Week 16

  10. Percentage of subjects achieving DAS28-CRP score for low disease activity (≦3.2)

    To assess DAS28-CRP score for efficacy

    Measured: Up to Week 16

  11. Percentage of subjects achieving DAS28-ESR score for low disease activity (≦3.2)

    To assess DAS28-ESR score for efficacy

    Measured: Up to Week 16

  12. Change from baseline in CRP

    To assess CRP (C-reactive protein) for efficacy

    Measured: Baseline and Up to Week 16

  13. Change from baseline in ESR

    To assess ESR (Erythrocyte sedimentation rate) for efficacy

    Measured: Baseline and Up to Week 16

  14. Percentage of subjects achieving EULAR response criteria of "Good Response"

    To assess EULAR (European league Against Rheumatism) response criteria for efficacy

    Measured: Up to Week 16

  15. Percentage of subjects achieving EULAR response criteria of "Good Response" or "Moderate Response"

    To assess EULAR response criteria for efficacy

    Measured: Up to Week 16

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

    To assess ACR/EULAR remission for efficacy

    Measured: Up to Week 16

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

    To assess SDAI (Simplified Disease Activity Index) score for efficacy

    Measured: Up to Week 16

  18. Percentage of subjects achieving CDAI score ≦ 2.8 (CDAI remission)

    To assess CDAI (Clinical Disease Activity Index) score for efficacy

    Measured: Up to Week 16

  19. Change from baseline for the HAQ-DI

    To assess HAQ-DI (Health Assessment Questionnaire - Disability Index) for efficacy

    Measured: Baseline to Up to Week 16

  20. Safety assessed by incidence of adverse events

    Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA).

    Measured: Up to Week 16

  21. Safety assessed by laboratory tests: Hematology

    To assess hematology as a criteria of safety variables.

    Measured: Up to Week 16

  22. Safety assessed by laboratory tests: Biochemistry

    To assess Biochemistry as a criteria of safety variables.

    Measured: Up to Week 16

  23. Safety assessed by laboratory tests: Urinalysis

    To assess Urinalysis as a criteria of safety variables.

    Measured: Up to Week 16

  24. Safety assessed by vital signs: Body temperature

    To assess the vital sign as a criteria of safety variables.

    Measured: Up to Week 16

  25. Safety assessed by vital signs: Sitting blood pressure

    To assess the vital sign as a criteria of safety variables.

    Measured: Up to Week 16

  26. Safety assessed by vital signs: pulse rate

    To assess the vital sign as a criteria of safety variables.

    Measured: Up to Week 16

  27. Safety assessed by weight

    To assess the weight as a criteria of safety variables.

    Measured: Up to Week 16

  28. Safety assessed by standard 12-lead electrocardiogram

    To assess the cardiovascular system functioning as a criteria of safety variables.

    Measured: Up to Week 16

  29. Serum concentration of ASP5094

    To assess Serum concentration of ASP5094 for pharmacokinetics

    Measured: Up to Week 16

  30. Serum concentration of TNF-α

    To assess TNF-α (Tumor Necrosis Factor-α) for pharmacodynamics

    Measured: Up to Week 16

  31. Serum concentration of MMP3

    To assess MMP3 (Matrix metalloproteinase 3) for pharmacodynamics

    Measured: Up to Week 16

  32. Serum concentration of IL-6

    To assess IL-6 (Interleukin-6) for pharmacodynamics

    Measured: Up to Week 16

  33. Anti-ASP5094 anti-bodies

    To assess Anti-ASP5094 anti-bodies for immunogenicity

    Measured: Up to Week 16

Timeline

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

  1. First posted22 Aug 2017
  2. Study start29 Sep 2017
  3. Primary completion19 Sep 2018
  4. Study completion16 Oct 2018

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03257852
Sponsor's protocol ID
5094-CL-0201
Status last verified
Oct 2024
First submitted
20 Aug 2017
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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/.

Publications

  • Takeuchi T, Tanaka Y, Erdman J, Kaneko Y, Saito M, Higashitani C, Smulders R, Lademacher C. ASP5094, a humanized monoclonal antibody against integrin alpha-9, did not show efficacy in patients with rheumatoid arthritis refractory to methotrexate: results from a phase 2a, randomized, double-blind, placebo-controlled trial. Arthritis Res Ther. 2020 Oct 21;22(1):252. doi: 10.1186/s13075-020-02336-3.

    PubMed 33087159

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASP5094 and Methotrexate therapy in people with Rheumatoid Arthritis (RA), run by Astellas Pharma Inc at 31 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 7 inclusion and 15 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 31 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 31 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?

ACR50 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 NCT03257852, which also lists 1 linked publication.

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 31 Oct 2024.

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