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

Rheumatoid Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884635
• Other study ID #: 1707-CL-3001
• Status: Completed
• Phase: Phase 2
• Start date: September 16, 2016
• Est. completion date: October 25, 2017

Study information

• Verified date: October 2018
• 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, pharmacokinetics, pharmacodynamics and safety of ASP1707 in combination with MTX in postmenopausal female patients with RA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 25, 2017
• Est. primary completion date: October 18, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

• 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.

Exclusion Criteria:

• 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

• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• ASP1707
Oral
• Placebo
Oral
• Methotrexate
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.

Locations

Country	Name	City	State
Japan	Site JP00022	Aichi
Japan	Site JP00023	Aichi
Japan	Site JP00017	Chiba
Japan	Site JP00026	Ehime
Japan	Site JP00025	Fukui
Japan	Site JP00012	Fukuoka
Japan	Site JP00018	Fukuoka
Japan	Site JP00019	Fukuoka
Japan	Site JP00006	Gunma
Japan	Site JP00024	Gunma
Japan	Site JP00010	Hiroshima
Japan	Site JP00011	Hiroshima
Japan	Site JP00001	Hokkaido
Japan	Site JP00002	Hokkaido
Japan	Site JP00003	Hokkaido
Japan	Site JP00004	Iwate
Japan	Site JP00005	Iwate
Japan	Site JP00016	Kagoshima
Japan	Site JP00007	Kanagawa
Japan	Site JP00021	Kanagawa
Japan	Site JP00014	Kumamoto
Japan	Site JP00015	Kumamoto
Japan	Site JP00013	Nagasaki
Japan	Site JP00020	Oita
Japan	Site JP00008	Shizuoka
Japan	Site JP00009	Shizuoka
Japan	Site JP00027	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20 response rate	ACR20: American College of Rheumatology 20	Week 12
Secondary	ACR20 response rate		Up to Week 8
Secondary	ACR50 response rate		Up to Week 12
Secondary	ACR70 response rate		Up to Week 12
Secondary	Change from baseline in DAS28-CRP score	DAS28-CRP: Disease Activity Score28 - C-reactive protein	Baseline and Up to Week 12
Secondary	Change from baseline in DAS28-ESR score	DAS28-ESR: Disease Activity Score28 - Erythrocyte sedimentation rate	Baseline and Up to Week 12
Secondary	Change from baseline in Tender Joint Count (68 joints)		Baseline and Up to Week 12
Secondary	Change from baseline in Swollen Joint Count (66 joints)		Baseline and Up to Week 12
Secondary	Percentage of subjects achieving DAS28-CRP score and DAS28-ESR score for remission (<2.6)		Up to Week 12
Secondary	Percentage of subjects achieving DAS28-CRP score and DAS28-ESR score for low disease activity (=3.2)		Up to Week 12
Secondary	Change from baseline in CRP		Baseline and Up to Week 12
Secondary	Change from baseline in ESR		Baseline and Up to Week 12
Secondary	Percentage of subjects achieving EULAR response criterion of "Good Response"	EULAR: European league Against Rheumatism	Up to Week 12
Secondary	Percentage of subjects achieving EULAR response criterion of "Good Response" or "Moderate Response"		Up to Week 12
Secondary	Percentage of subjects achieving ACR/EULAR score for remission		Up to Week 12
Secondary	Percentage of subjects achieving SDAI score ? 3.3 (SDAI remission)	SDAI: Simplified Disease Activity Index	Up to Week 12
Secondary	Change from baseline in the SDAI score		Baseline and Up to Week 12
Secondary	Change from baseline for the HAQ-DI	HAQ-DI: Health Assessment Questionnaire - Disability Index	Baseline and Up to Week 12
Secondary	Safety assessed by incidence of adverse events		Up to Week 13
Secondary	Safety assessed by body temperature		Up to Week 13
Secondary	Safety assessed by pulse rate		Up to Week 13
Secondary	Safety assessed by blood pressure in sitting position		Up to Week 13
Secondary	Safety assessed by laboratory tests: Hematology		Up to Week 13
Secondary	Safety assessed by laboratory tests: Biochemistry		Up to Week 13
Secondary	Safety assessed by laboratory tests: Urinalysis		Up to Week 13
Secondary	Safety assessed by standard 12-lead electrocardiogram		Up to Week 13
Secondary	Safety assessed by weight		Up to Week 13
Secondary	Plasma concentration of ASP1707		Up to Week 12
Secondary	Plasma concentration of metabolite of ASP1707		Up to Week 12
Secondary	Pharmacodynamics assessed by endocrinology tests		Up to Week 13
Secondary	Pharmacodynamics assessed by plasma concentration of TNF-a	TNF: Tumor Necrosis Factor	Up to Week 13
Secondary	Pharmacodynamics assessed by plasma concentration of MMP3	MMP3: Matrix metalloproteinase 3	Up to Week 13
Secondary	Pharmacodynamics assessed by plasma concentration of IL-6	IL-6: Interleukin-6	Up to Week 13

External Links

•   Link to results on the Astellas Clinical Study Results website