A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate
- Conditions
- Rheumatoid Arthritis (RA)
- Interventions
- Registration Number
- NCT03257852
- Lead Sponsor
- Astellas Pharma Inc
- Brief 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).
- Detailed Description
The study drug will be intravenously administered.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASP5094 Group ASP5094 To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate. ASP5094 Group Methotrexate therapy To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate. Placebo Group Placebo To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate. Placebo Group Methotrexate therapy To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
- Primary Outcome Measures
Name Time Method ACR50 response rate Week 12 To assess ACR (American College of Rheumatology) 50 for efficacy
- Secondary Outcome Measures
Name Time Method ACR50 response rate Up to Week 16 To assess ACR (American College of Rheumatology) 50 for efficacy
ACR20 response rate Up to Week 16 To assess ACR (American College of Rheumatology) 20 for efficacy
Anti-ASP5094 anti-bodies Up to Week 16 To assess Anti-ASP5094 anti-bodies for immunogenicity
ACR70 response rate Up to Week 16 To assess ACR (American College of Rheumatology) 70 for efficacy
Percentage of subjects achieving SDAI score ≦ 3.3 (SDAI remission) Up to Week 16 To assess SDAI (Simplified Disease Activity Index) score for efficacy
Change from baseline in DAS28-CRP score Baseline and Up to Week 16 To assess DAS28-CRP (Disease Activity Score28 - C-reactive protein) for efficacy
Change from baseline in Tender Joint Count (68 joints) Baseline and Up to Week 16 To assess Tender Joint Count for efficacy
Percentage of subjects achieving DAS28-ESR score for remission (<2.6) Up to Week 16 To assess DAS28-ESR score for efficacy
Percentage of subjects achieving DAS28-CRP score for low disease activity (≦3.2) Up to Week 16 To assess DAS28-CRP score for efficacy
Percentage of subjects achieving DAS28-ESR score for low disease activity (≦3.2) Up to Week 16 To assess DAS28-ESR score for efficacy
Change from baseline in CRP Baseline and Up to Week 16 To assess CRP (C-reactive protein) for efficacy
Percentage of subjects achieving EULAR response criteria of "Good Response" Up to Week 16 To assess EULAR (European league Against Rheumatism) response criteria for efficacy
Serum concentration of TNF-α Up to Week 16 To assess TNF-α (Tumor Necrosis Factor-α) for pharmacodynamics
Change from baseline in DAS28-ESR score Baseline and Up to Week 16 To assess DAS28-ESR (Disease Activity Score28 - Erythrocyte sedimentation rate) for efficacy
Change from baseline in Swollen Joint Count (66 joints) Baseline and Up to Week 16 To assess Swollen Joint Count for efficacy
Percentage of subjects achieving DAS28-CRP score for remission (<2.6) Up to Week 16 To assess DAS28-CRP score for efficacy
Percentage of subjects achieving EULAR response criteria of "Good Response" or "Moderate Response" Up to Week 16 To assess EULAR response criteria for efficacy
Percentage of subjects achieving ACR/EULAR score for remission Up to Week 16 To assess ACR/EULAR remission for efficacy
Change from baseline for the HAQ-DI Baseline to Up to Week 16 To assess HAQ-DI (Health Assessment Questionnaire - Disability Index) for efficacy
Serum concentration of MMP3 Up to Week 16 To assess MMP3 (Matrix metalloproteinase 3) for pharmacodynamics
Serum concentration of IL-6 Up to Week 16 To assess IL-6 (Interleukin-6) for pharmacodynamics
Change from baseline in ESR Baseline and Up to Week 16 To assess ESR (Erythrocyte sedimentation rate) for efficacy
Percentage of subjects achieving CDAI score ≦ 2.8 (CDAI remission) Up to Week 16 To assess CDAI (Clinical Disease Activity Index) score for efficacy
Safety assessed by incidence of adverse events Up to Week 16 Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Safety assessed by laboratory tests: Hematology Up to Week 16 To assess hematology as a criteria of safety variables.
Safety assessed by laboratory tests: Biochemistry Up to Week 16 To assess Biochemistry as a criteria of safety variables.
Safety assessed by laboratory tests: Urinalysis Up to Week 16 To assess Urinalysis as a criteria of safety variables.
Safety assessed by vital signs: Body temperature Up to Week 16 To assess the vital sign as a criteria of safety variables.
Safety assessed by vital signs: Sitting blood pressure Up to Week 16 To assess the vital sign as a criteria of safety variables.
Safety assessed by vital signs: pulse rate Up to Week 16 To assess the vital sign as a criteria of safety variables.
Safety assessed by weight Up to Week 16 To assess the weight as a criteria of safety variables.
Safety assessed by standard 12-lead electrocardiogram Up to Week 16 To assess the cardiovascular system functioning as a criteria of safety variables.
Serum concentration of ASP5094 Up to Week 16 To assess Serum concentration of ASP5094 for pharmacokinetics
Trial Locations
- Locations (31)
Site JP00016
🇯🇵Ichinomiya, Japan
Site JP00005
🇯🇵Kitamoto, Japan
Site JP00011
🇯🇵Oita, Japan
Site JP00025
🇯🇵Kobe, Japan
Site JP00027
🇯🇵Asahikawa, Japan
Site JP00008
🇯🇵Fukuoka, Japan
Site JP00006
🇯🇵Kyoto, Japan
Site JP00010
🇯🇵Kumamoto, Japan
Site JP00020
🇯🇵Nagano, Japan
Site JP00014
🇯🇵Nagoya, Japan
Site JP00003
🇯🇵Osaki, Japan
Site JP00024
🇯🇵Tsukuba, Japan
Site JP00017
🇯🇵Tomakomai, Japan
Site JP00009
🇯🇵Fukuoka, Japan
Site JP00012
🇯🇵Kanuma, Japan
Site JP00028
🇯🇵Kawachinagano, Japan
Site JP00030
🇯🇵Kobe, Japan
Site JP00018
🇯🇵Meguro, Japan
Site JP00022
🇯🇵Okayama, Japan
Site JP00019
🇯🇵Sagamihara, Japan
Site JP00007
🇯🇵Sanuki, Japan
Site JP00001
🇯🇵Sapporo, Japan
Site JP00023
🇯🇵Shimonoseki, Japan
Site JP00013
🇯🇵Toyohashi, Japan
Site JP00015
🇯🇵Chiba, Japan
Site JP00026
🇯🇵Fukuoka, Japan
Site JP00002
🇯🇵Asahikawa, Japan
Site JP00029
🇯🇵Beppu, Japan
Site JP00021
🇯🇵Shizuoka, Japan
Site JP00004
🇯🇵Takasaki, Japan
Site JP00031
🇯🇵Yokohama, Japan