A Randomized Controlled, Double-blind, Phase III, Multicenter Clinical Study of HS628 Versus Actemra® in Combination With Methotrexate as Therapy in Patients With Moderate to Severe Rheumatoid Arthritis

Zhejiang Hisun Pharmaceutical Co. Ltd.1 site in 1 country669 target enrollmentDecember 28, 2020

ConditionsModerate to Severe Active Rheumatoid Arthritis

InterventionsHS628+MTX Actemra +MTX

DrugsHS628+MTX Actemra +MTX

Overview

Phase: Phase 3
Intervention: HS628+MTX
Conditions: Moderate to Severe Active Rheumatoid Arthritis
Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
Enrollment: 669
Locations: 1
Primary Endpoint: Proportion of patients with an ACR20 response
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-center, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of intravenous HS628 in combination with MTX versus Actemra in combination with MTX, in participants with moderate to severe active rheumatoid arthritis (RA) who have inadequate response to current MTX therapy. The study comprises a 24-week treatment phase, followed by a 4-week safety observation period.

Registry

clinicaltrials.gov

Start Date

December 28, 2020

End Date

January 31, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhejiang Hisun Pharmaceutical Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•the person who has signed the informed consent and can complete the test according to the program;
•age ≥18 years old and ≤75 years old (subject to the date of signing the informed consent), male or female;
•weight ≥30kg;
•according to the 2010 ACR/EULAR diagnostic criteria, rheumatoid arthritis was diagnosed with the disease duration ≥ 6 months;
•swelling and tenderness joint count ≥ 6 (based on 66 joint counts) and tenderness joint count ≥ 6 (based on 68 joint counts) during the screening period, if both swelling and tenderness are present in the same joint, the joint shall be included in both swelling and tenderness joint count (excluding artificial joints);
•C-reactive protein (CRP) ≥10mg/L or erythrocyte sedimentation rate (ESR) \> 28mm/hr at the screening stage;
•patinents who had received DMARD treatment for at least 3 months before screening visit;
•Inadequate response to previous or current methotrexate treatment;
•patients who received at least 12 weeks of oral methotrexate treatment (≥ 7.5mg/week) and at least 4 weeks of stable oral dose (methotrexate dose 7.5-25mg/week, with critical value) before random administration;
•all non-biological agents DMARD except methotrexate should be discontinued for at least 2 weeks before random administration( In addition, leflunomide should be discontinued for ≥8 weeks, and at least 2 weeks before randomized administration if standard coletenide therapy or activated carbon elution has been followed; Discontinuation of sulfasalazine ≥4 weeks; Yunke withdrawal ≥12 weeks）;

Exclusion Criteria

•Subjects have previously received Tocilizumab treatment or are allergic to any component of Tocilizumab (or investigational drug product);
•Subjects with long-term bedridden/wheelchair;
•Subjects with inflammatory joint disease other than rheumatoid arthritis in their previous or current medical history; or other systemic autoimmune diseases;
•Current symptoms of severe, progressive or uncontrolled diseases of renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral. Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study;
•Subjects with history of severe hypersensitivity or anaphylaxis to human, humanized or mouse monoclonal antibodies.

Arms & Interventions

HS628

Subjects will receive 8mg/kg intravenous(IV) HS628 at Week 0,Week 4, Week 8, Week 12, Week 16, Week 20,Week 24

Intervention: HS628+MTX

Actemra

Subjects will receive 8mg/kg intravenous(IV) ACTEMRA® at Week 0,Week 4, Week 8, Week 12, Week 16, Week 20,Week 24

Intervention: Actemra +MTX

Outcomes

Primary Outcomes

Proportion of patients with an ACR20 response

Time Frame: Week 24

The ACR 20 responses: greater than or equal to 20 percent improvement in TJC and SJC (28 assessed joints), and 20% improvement in 3 of the following 5 criteria, respectively: 1) PtAAP- VAS, 2) PtGADA-VAS, 3) PhGADA-VAS, 4) HAQ-DI, and 5) CRP or ESR

Secondary Outcomes

Change From Baseline in VAS（PtAAP-VAS、PtGADA-VAS、PhGADA-VAS）(Week 12、Week 24)
Proportion of patients with an ACR20, 50, 70 response(Week 12)
Simplified Disease Activity Index (SDAI)Change From Baseline(Week 12、 Week 24)
Change From Baseline in TJC and SJC(Week 24)
Change From Baseline in ESR(Week 12、Week 24)
Proportion of patients with an ACR50, 70 response(Week 24)
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)(Week 24)
Change From Baseline in CRP(Week 12、Week 24)
Proportion of patients with DAS28 (ESP、CRP) ≤3.2 and <2.6(Week 24)
Change From Baseline in the Short Form 36 (SF-36) Health Survey(Week 24)
Clinical Disease Activity Index (CDAI)（Change From Baseline）(Week 12、 Week 24)