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

Rheumatoid Arthritis (RA) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257852
• Other study ID #: 5094-CL-0201
• Status: Completed
• Phase: Phase 2
• Start date: September 29, 2017
• Est. completion date: October 16, 2018

Study information

• Verified date: October 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Description:

The study drug will be intravenously administered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 16, 2018
• Est. primary completion date: September 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Intervention

Drug:
• ASP5094
intravenously administration
• Placebo
intravenously administration

Other:
• Methotrexate therapy
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.

Locations

Country	Name	City	State
Japan	Site JP00002	Asahikawa
Japan	Site JP00027	Asahikawa
Japan	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	Kawachinagano
Japan	Site JP00005	Kitamoto
Japan	Site JP00025	Kobe
Japan	Site JP00030	Kobe
Japan	Site JP00010	Kumamoto
Japan	Site JP00006	Kyoto
Japan	Site JP00018	Meguro
Japan	Site JP00020	Nagano
Japan	Site JP00014	Nagoya
Japan	Site JP00011	Oita
Japan	Site JP00022	Okayama
Japan	Site JP00003	Osaki
Japan	Site JP00019	Sagamihara
Japan	Site JP00007	Sanuki
Japan	Site JP00001	Sapporo
Japan	Site JP00023	Shimonoseki
Japan	Site JP00021	Shizuoka
Japan	Site JP00004	Takasaki
Japan	Site JP00017	Tomakomai
Japan	Site JP00013	Toyohashi
Japan	Site JP00024	Tsukuba
Japan	Site JP00031	Yokohama

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR50 response rate	To assess ACR (American College of Rheumatology) 50 for efficacy	Week 12
Secondary	ACR50 response rate	To assess ACR (American College of Rheumatology) 50 for efficacy	Up to Week 16
Secondary	ACR20 response rate	To assess ACR (American College of Rheumatology) 20 for efficacy	Up to Week 16
Secondary	ACR70 response rate	To assess ACR (American College of Rheumatology) 70 for efficacy	Up to Week 16
Secondary	Change from baseline in DAS28-CRP score	To assess DAS28-CRP (Disease Activity Score28 - C-reactive protein) for efficacy	Baseline and Up to Week 16
Secondary	Change from baseline in DAS28-ESR score	To assess DAS28-ESR (Disease Activity Score28 - Erythrocyte sedimentation rate) for efficacy	Baseline and Up to Week 16
Secondary	Change from baseline in Tender Joint Count (68 joints)	To assess Tender Joint Count for efficacy	Baseline and Up to Week 16
Secondary	Change from baseline in Swollen Joint Count (66 joints)	To assess Swollen Joint Count for efficacy	Baseline and Up to Week 16
Secondary	Percentage of subjects achieving DAS28-CRP score for remission (<2.6)	To assess DAS28-CRP score for efficacy	Up to Week 16
Secondary	Percentage of subjects achieving DAS28-ESR score for remission (<2.6)	To assess DAS28-ESR score for efficacy	Up to Week 16
Secondary	Percentage of subjects achieving DAS28-CRP score for low disease activity (?3.2)	To assess DAS28-CRP score for efficacy	Up to Week 16
Secondary	Percentage of subjects achieving DAS28-ESR score for low disease activity (?3.2)	To assess DAS28-ESR score for efficacy	Up to Week 16
Secondary	Change from baseline in CRP	To assess CRP (C-reactive protein) for efficacy	Baseline and Up to Week 16
Secondary	Change from baseline in ESR	To assess ESR (Erythrocyte sedimentation rate) for efficacy	Baseline and Up to Week 16
Secondary	Percentage of subjects achieving EULAR response criteria of "Good Response"	To assess EULAR (European league Against Rheumatism) response criteria for efficacy	Up to Week 16
Secondary	Percentage of subjects achieving EULAR response criteria of "Good Response" or "Moderate Response"	To assess EULAR response criteria for efficacy	Up to Week 16
Secondary	Percentage of subjects achieving ACR/EULAR score for remission	To assess ACR/EULAR remission for efficacy	Up to Week 16
Secondary	Percentage of subjects achieving SDAI score ? 3.3 (SDAI remission)	To assess SDAI (Simplified Disease Activity Index) score for efficacy	Up to Week 16
Secondary	Percentage of subjects achieving CDAI score ? 2.8 (CDAI remission)	To assess CDAI (Clinical Disease Activity Index) score for efficacy	Up to Week 16
Secondary	Change from baseline for the HAQ-DI	To assess HAQ-DI (Health Assessment Questionnaire - Disability Index) for efficacy	Baseline to Up to Week 16
Secondary	Safety assessed by incidence of adverse events	Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA).	Up to Week 16
Secondary	Safety assessed by laboratory tests: Hematology	To assess hematology as a criteria of safety variables.	Up to Week 16
Secondary	Safety assessed by laboratory tests: Biochemistry	To assess Biochemistry as a criteria of safety variables.	Up to Week 16
Secondary	Safety assessed by laboratory tests: Urinalysis	To assess Urinalysis as a criteria of safety variables.	Up to Week 16
Secondary	Safety assessed by vital signs: Body temperature	To assess the vital sign as a criteria of safety variables.	Up to Week 16
Secondary	Safety assessed by vital signs: Sitting blood pressure	To assess the vital sign as a criteria of safety variables.	Up to Week 16
Secondary	Safety assessed by vital signs: pulse rate	To assess the vital sign as a criteria of safety variables.	Up to Week 16
Secondary	Safety assessed by weight	To assess the weight as a criteria of safety variables.	Up to Week 16
Secondary	Safety assessed by standard 12-lead electrocardiogram	To assess the cardiovascular system functioning as a criteria of safety variables.	Up to Week 16
Secondary	Serum concentration of ASP5094	To assess Serum concentration of ASP5094 for pharmacokinetics	Up to Week 16
Secondary	Serum concentration of TNF-a	To assess TNF-a (Tumor Necrosis Factor-a) for pharmacodynamics	Up to Week 16
Secondary	Serum concentration of MMP3	To assess MMP3 (Matrix metalloproteinase 3) for pharmacodynamics	Up to Week 16
Secondary	Serum concentration of IL-6	To assess IL-6 (Interleukin-6) for pharmacodynamics	Up to Week 16
Secondary	Anti-ASP5094 anti-bodies	To assess Anti-ASP5094 anti-bodies for immunogenicity	Up to Week 16

External Links

•   Link to results on the Astellas Clinical Study Results website