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

Astellas Pharma Inc66 enrolled

Overview

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).

The study drug will be intravenously administered.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Rheumatoid Arthritis (RA)

Interventions

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (31)

Site JP00002

Asahikawa, Japan

Site JP00027

Outcomes

Primary Outcomes

ACR50 response rate

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

Time frame: Week 12

Secondary Outcomes

ACR50 response rate

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

Time frame: Up to Week 16

ACR20 response rate

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

Time frame: Up to Week 16

ACR70 response rate

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

Time frame: Up to Week 16

Change from baseline in DAS28-CRP score

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

Time frame: Baseline and Up to Week 16

Change from baseline in DAS28-ESR score

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

Time frame: Baseline and Up to Week 16

Change from baseline in Tender Joint Count (68 joints)

To assess Tender Joint Count for efficacy

Time frame: Baseline and Up to Week 16

Change from baseline in Swollen Joint Count (66 joints)

To assess Swollen Joint Count for efficacy

Time frame: Baseline and Up to Week 16

Data from ClinicalTrials.gov

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Site JP00029

Beppu, Japan

Site JP00015

Chiba, Japan

Site JP00008

Fukuoka, Japan

Site JP00009

Fukuoka, Japan

Site JP00026

Fukuoka, Japan

Site JP00016

Ichinomiya, Japan

Site JP00012

Kanuma, Japan

Site JP00028

Kawachi-Nagano, Japan

...and 21 more locations

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

To assess DAS28-CRP score for efficacy

Time frame: Up to Week 16

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

To assess DAS28-ESR score for efficacy

Time frame: Up to Week 16

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

To assess DAS28-CRP score for efficacy

Time frame: Up to Week 16

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

To assess DAS28-ESR score for efficacy

Time frame: Up to Week 16

Change from baseline in CRP

To assess CRP (C-reactive protein) for efficacy

Time frame: Baseline and Up to Week 16

Change from baseline in ESR

To assess ESR (Erythrocyte sedimentation rate) for efficacy

Time frame: Baseline and Up to Week 16

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

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

Time frame: Up to Week 16

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

To assess EULAR response criteria for efficacy

Time frame: Up to Week 16

Percentage of subjects achieving ACR/EULAR score for remission

To assess ACR/EULAR remission for efficacy

Time frame: Up to Week 16

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

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

Time frame: Up to Week 16

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

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

Time frame: Up to Week 16

Change from baseline for the HAQ-DI

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

Time frame: Baseline to Up to Week 16

Safety assessed by incidence of adverse events

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

Time frame: Up to Week 16

Safety assessed by laboratory tests: Hematology

To assess hematology as a criteria of safety variables.

Time frame: Up to Week 16

Safety assessed by laboratory tests: Biochemistry

To assess Biochemistry as a criteria of safety variables.

Time frame: Up to Week 16

Safety assessed by laboratory tests: Urinalysis

To assess Urinalysis as a criteria of safety variables.

Time frame: Up to Week 16

Safety assessed by vital signs: Body temperature

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

Time frame: Up to Week 16

Safety assessed by vital signs: Sitting blood pressure

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

Time frame: Up to Week 16

Safety assessed by vital signs: pulse rate

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

Time frame: Up to Week 16

Safety assessed by weight

To assess the weight as a criteria of safety variables.

Time frame: Up to Week 16

Safety assessed by standard 12-lead electrocardiogram

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

Time frame: Up to Week 16

Serum concentration of ASP5094

To assess Serum concentration of ASP5094 for pharmacokinetics

Time frame: Up to Week 16

Serum concentration of TNF-α

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

Time frame: Up to Week 16

Serum concentration of MMP3

To assess MMP3 (Matrix metalloproteinase 3) for pharmacodynamics

Time frame: Up to Week 16

Serum concentration of IL-6

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

Time frame: Up to Week 16

Anti-ASP5094 anti-bodies

To assess Anti-ASP5094 anti-bodies for immunogenicity

Time frame: Up to Week 16