Clinical Trials/NCT02884635

NCT02884635

Completed

Phase 2

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)

Astellas Pharma Inc27 sites in 1 country72 target enrollmentSeptember 16, 2016

ConditionsRheumatoid Arthritis

InterventionsASP1707 Methotrexate Placebo

DrugsASP1707 Placebo Methotrexate

Overview

Phase: Phase 2
Intervention: ASP1707
Conditions: Rheumatoid Arthritis
Sponsor: Astellas Pharma Inc
Enrollment: 72
Locations: 27
Primary Endpoint: ACR20 response rate
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 16, 2016

End Date

October 25, 2017

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Astellas Pharma Inc

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

ASP1707

ASP1707 will be orally administered for 12 weeks.

Intervention: ASP1707

ASP1707

ASP1707 will be orally administered for 12 weeks.

Intervention: Methotrexate

Placebo

Placebo will be orally administered for 12 weeks.

Intervention: Placebo

Placebo

Placebo will be orally administered for 12 weeks.

Intervention: Methotrexate

Outcomes

Primary Outcomes

ACR20 response rate

Time Frame: Week 12

ACR20: American College of Rheumatology 20

Secondary Outcomes

ACR50 response rate(Up to Week 12)
Percentage of subjects achieving EULAR response criterion of "Good Response"(Up to Week 12)
Change from baseline in Tender Joint Count (68 joints)(Baseline and Up to Week 12)
Change from baseline in Swollen Joint Count (66 joints)(Baseline and Up to Week 12)
Change from baseline in CRP(Baseline and Up to Week 12)
ACR20 response rate(Up to Week 8)
Percentage of subjects achieving DAS28-CRP score and DAS28-ESR score for remission (<2.6)(Up to Week 12)
Percentage of subjects achieving DAS28-CRP score and DAS28-ESR score for low disease activity (≤3.2)(Up to Week 12)
ACR70 response rate(Up to Week 12)
Change from baseline in ESR(Baseline and Up to Week 12)
Safety assessed by incidence of adverse events(Up to Week 13)
Safety assessed by pulse rate(Up to Week 13)
Safety assessed by laboratory tests: Hematology(Up to Week 13)
Safety assessed by laboratory tests: Biochemistry(Up to Week 13)
Safety assessed by laboratory tests: Urinalysis(Up to Week 13)
Change from baseline in DAS28-CRP score(Baseline and Up to Week 12)
Change from baseline in DAS28-ESR score(Baseline and Up to Week 12)
Change from baseline in the SDAI score(Baseline and Up to Week 12)
Safety assessed by body temperature(Up to Week 13)
Safety assessed by standard 12-lead electrocardiogram(Up to Week 13)
Safety assessed by weight(Up to Week 13)
Pharmacodynamics assessed by plasma concentration of TNF-α(Up to Week 13)
Percentage of subjects achieving ACR/EULAR score for remission(Up to Week 12)
Percentage of subjects achieving SDAI score ≦ 3.3 (SDAI remission)(Up to Week 12)
Plasma concentration of metabolite of ASP1707(Up to Week 12)
Pharmacodynamics assessed by endocrinology tests(Up to Week 13)
Percentage of subjects achieving EULAR response criterion of "Good Response" or "Moderate Response"(Up to Week 12)
Change from baseline for the HAQ-DI(Baseline and Up to Week 12)
Safety assessed by blood pressure in sitting position(Up to Week 13)
Pharmacodynamics assessed by plasma concentration of MMP3(Up to Week 13)
Plasma concentration of ASP1707(Up to Week 12)
Pharmacodynamics assessed by plasma concentration of IL-6(Up to Week 13)