Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)

Coherus Oncology, Inc.647 enrolled

Overview

This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies. Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety. Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

647

Conditions

Rheumatoid Arthritis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female adults * RA (Rheumatoid Arthritis) diagnosis for 6 months * On stable dose of MTX of 8mg to 25mg per week * Active disease: greater than 6 tender joints, greater than 6 swollen joints, C-reactive protein (CRP) greater than or equal to 0.5mg/dL, and disease activity score (DAS) with 28 joints (DAS28-CRP(4)) greater than or equal to 3.2 Exclusion Criteria: * Use of prednisone greater than 10mg/day * Use of greater than one non-steroidal anti-inflammatory drug (NSAID) * Use of biologic therapies for any cause * Chemistry and hematology values outside protocol specified range * Positive QuantiFERON-tuberculosis (TB) Gold Test * Evidence of active lung disease on chest x-ray * Major systemic infections * Presence of significant comorbid conditions * Known allergy to latex * Women who are pregnant or nursing

Locations (141)

Elite Clinical Studies

Phoenix, Arizona, United States

Arizona Research Center

Phoenix, Arizona, United States

NEA Baptist Clinic

Jonesboro, Arkansas, United States

Dream Team Clinical Research

Anaheim, California, United States

Advanced Medical Research

Lakewood, California, United States

Outcomes

Primary Outcomes

ACR-20 - 20% Improvement According to American College of Rheumatology Criteria

The primary efficacy endpoint in Part 1 was the percentage of subjects who achieved ACR20 (20% improvement according to American College of Rheumatology criteria) at week 24 compared to baseline (last non-missing value prior to first dose). Subjects were considered an ACR20 responder if when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC (Swollen joint count), 20% decrease in TJC (Tender joint count), and 20% improvement in 3 of the following 5 measures: high sensitivity C reactive protein(hs-CRP), Health Assessment Questionnaire Disability Index(HAQ-DI), subjects global assessment of pain(SPA, VAS), subject's global assessment of disease activity(SGA-VAS), physician's global assessment of disease activity(PGA-VAS)

Time frame: 24-weeks

Secondary Outcomes

ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18

Subjects were considered an ACR20 responder if, when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC, 20% decrease in TJC, and 20% improvement in 3 of the following 5 measures: * High sensitivity C-reactive protein (hs-CRP); * Health Assessment Questionnaire-Disability Index (HAQ-DI); * Subject's global assessment of pain (ie, subject's pain assessment \[SPA\]-visual analog scale \[VAS\]); * Subject's global assessment of disease activity (SGA-VAS); and * Physician's global assessment of disease activity (PGA-VAS). In these calculations, the percent change from baseline to endpoint was used to determine ACR20. For percentage change calculations, results were rounded to 5 decimal places prior to comparing to the threshold of 20%.For SJCs and TJCs, the assessment of efficacy was based on mean change from baseline (last non-missing value prior to first dose evaluation).

Time frame: Weeks 4, 8, 12 and 18

Summary of Change in Tender Joint Count (TJC) by Study Visit

The average percent improvement from baseline in individual ACR response criteria: TJC (Tender joint count) the 66/68 Joint Count evaluates 68 joints for tenderness and pain with movement. The temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), distal interphalangeal (DIP), hip, knee, ankle, tarsus, metatarsophalangeal (MTP), and interphalangeal of the feet are included in this joint count. Hip joints can be evaluated for tenderness.