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A Long Term Safety Extension Study (CHS-0214-05)

Primary Purpose

Rheumatoid Arthritis, Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
CHS-0214
Sponsored by
Coherus Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have completed 48 weeks of evaluations in CHS-0214-02 and, at Week 48, had at least an ACR20, or completed 48 weeks of evaluations in CHS-0214-04 and, at Week 48, had at least a PASI-50

Exclusion Criteria:

  • None

Sites / Locations

  • Oribe Clinic of Rheumatism and Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CHS-0214

Arm Description

CHS-0214 50 mg weekly

Outcomes

Primary Outcome Measures

Durability of Response (Maintenance of an ACR20 Response or Greater), Which Was Measured at Each Visit in Subjects of RA
The ACR20 is a composite endpoint based on the following assessments: 66/68 swollen joint count (SJC) or tender joint count (TJC), Subject's pain assessment (SPA)-visual analog scale (VAS),Subject's global assessment of disease activity (SGA)-VAS,Physician's global assessment of disease activity (PGA)-VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and High sensitivity C-reactive protein (hs-CRP).The baseline value to assess the ACR20 during this study was the same baseline value used to assess the ACR20 during the parent study (ie, the Week 0 assessment in the parent study). Subjects were considered an ACR20 responder at a visit if compared to baseline in the parent study (CHS-0214-02) they achieved: At least 20% decrease in SJC, At least 20% decrease in TJC, and At least 20% improvement in at least 3 of the following 5 measures: C-reactive protein, HAQ-DI, SPA (using a VAS) for pain,SGA (using a VAS), orPGA (using a VAS).
In Subjects With PsO, Durability of Response (Maintenance of PASI-50 Response or Greater), Which Was Measured at Each Visit.
All PASI score assessors must have demonstrated proficiency at performing the PASI. Every attempt was made to use the same assessor for each subject throughout the study. n subjects with PsO, durability of response (maintenance of a PASI-50 response or greater at each assessment) was based on scoring the PsO lesions on a scale of 0 to 4 for 3 characteristics: erythema, induration, and desquamation, and within 4 anatomical regions: head, trunk, upper extremities, and lower extremities. Within each of these regions, the area of involvement was scored on a scale of 0 to 6, with the total score being a weighted average, and weights defined by the area of involvement. The clinician assessed the subject's PsO lesions according to the PASI and provided this score within the case report form at Weeks 0 (as the Week 48 assessment of the parent study), 4, 12, 24, 36, and 48. Subjects were classified as having a PASI-50 response based upon 50% reduction from baseline of the parent study.

Secondary Outcome Measures

Disease Activity Score Using 28 Tender and Swollen Joint Counts, High Sensitivity C-reactive Protein, and Subject's Global Assessment of Disease Activity (DAS28-CRP[4]) <3.2 (ie, Low Disease Activity) at All Visits for All Subjects With RA.
The DAS28-CRP(4) is a composite score (ranging from 0 to 9.4) calculated using the results of the TJC (using a 28 joint subset), SJC (using a 28 joint subset), hs-CRP level (mg/L), and SGA (0 to 100 scale). The DAS28-CRP(4) was calculated using the following formula:0.56*sqrt(28TJC) + 0.28*sqrt(28SJC) + 0.36*ln(CRP+1) + 0.014* SGA + 0.96. For DAS28-CRP(4), scores indicating high disease activity are >5.1; low disease activity are <3.2;and remission are <2.6.
DAS28-CRP(4) <2.6 (ie, Remission) on All Visits After DAS28-CRP(4) <2.6 Was Achieved for Subjects With RA.
The DAS28-CRP(4) is a composite score (ranging from 0 to 9.4) calculated using the results of the TJC (using a 28 joint subset), SJC (using a 28 joint subset), hs-CRP level (mg/L), and SGA (0 to 100 scale). The DAS28-CRP(4) was calculated using the following formula:0.56*sqrt(28TJC) + 0.28*sqrt(28SJC) + 0.36*ln(CRP+1) + 0.014* SGA + 0.96. For DAS28-CRP(4), scores indicating high disease activity are >5.1; low disease activity are <3.2;and remission are <2.6.

Full Information

First Posted
June 26, 2015
Last Updated
December 4, 2018
Sponsor
Coherus Biosciences, Inc.
Collaborators
Daiichi Sankyo Co., Ltd., Shire
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1. Study Identification

Unique Protocol Identification Number
NCT02486939
Brief Title
A Long Term Safety Extension Study (CHS-0214-05)
Official Title
An Open-Label Safety Extension Study (OLSES) Evaluating the Long Term Safety and Durability of Response of CHS-0214 (CHS-0214-05)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coherus Biosciences, Inc.
Collaborators
Daiichi Sankyo Co., Ltd., Shire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
An Open-label, Safety Extension Study (OLSES) evaluating the longer-term safety and durability of response of subjects who completed 48 weeks of evaluations in the confirmatory safety and efficacy studies, CHS 0214-02 or CHS-0214-04, evaluating CHS-0214 in patients with rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
359 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHS-0214
Arm Type
Experimental
Arm Description
CHS-0214 50 mg weekly
Intervention Type
Drug
Intervention Name(s)
CHS-0214
Intervention Description
Open label
Primary Outcome Measure Information:
Title
Durability of Response (Maintenance of an ACR20 Response or Greater), Which Was Measured at Each Visit in Subjects of RA
Description
The ACR20 is a composite endpoint based on the following assessments: 66/68 swollen joint count (SJC) or tender joint count (TJC), Subject's pain assessment (SPA)-visual analog scale (VAS),Subject's global assessment of disease activity (SGA)-VAS,Physician's global assessment of disease activity (PGA)-VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and High sensitivity C-reactive protein (hs-CRP).The baseline value to assess the ACR20 during this study was the same baseline value used to assess the ACR20 during the parent study (ie, the Week 0 assessment in the parent study). Subjects were considered an ACR20 responder at a visit if compared to baseline in the parent study (CHS-0214-02) they achieved: At least 20% decrease in SJC, At least 20% decrease in TJC, and At least 20% improvement in at least 3 of the following 5 measures: C-reactive protein, HAQ-DI, SPA (using a VAS) for pain,SGA (using a VAS), orPGA (using a VAS).
Time Frame
48 Weeks
Title
In Subjects With PsO, Durability of Response (Maintenance of PASI-50 Response or Greater), Which Was Measured at Each Visit.
Description
All PASI score assessors must have demonstrated proficiency at performing the PASI. Every attempt was made to use the same assessor for each subject throughout the study. n subjects with PsO, durability of response (maintenance of a PASI-50 response or greater at each assessment) was based on scoring the PsO lesions on a scale of 0 to 4 for 3 characteristics: erythema, induration, and desquamation, and within 4 anatomical regions: head, trunk, upper extremities, and lower extremities. Within each of these regions, the area of involvement was scored on a scale of 0 to 6, with the total score being a weighted average, and weights defined by the area of involvement. The clinician assessed the subject's PsO lesions according to the PASI and provided this score within the case report form at Weeks 0 (as the Week 48 assessment of the parent study), 4, 12, 24, 36, and 48. Subjects were classified as having a PASI-50 response based upon 50% reduction from baseline of the parent study.
Time Frame
Week 0,4,12,24,36,48
Secondary Outcome Measure Information:
Title
Disease Activity Score Using 28 Tender and Swollen Joint Counts, High Sensitivity C-reactive Protein, and Subject's Global Assessment of Disease Activity (DAS28-CRP[4]) <3.2 (ie, Low Disease Activity) at All Visits for All Subjects With RA.
Description
The DAS28-CRP(4) is a composite score (ranging from 0 to 9.4) calculated using the results of the TJC (using a 28 joint subset), SJC (using a 28 joint subset), hs-CRP level (mg/L), and SGA (0 to 100 scale). The DAS28-CRP(4) was calculated using the following formula:0.56*sqrt(28TJC) + 0.28*sqrt(28SJC) + 0.36*ln(CRP+1) + 0.014* SGA + 0.96. For DAS28-CRP(4), scores indicating high disease activity are >5.1; low disease activity are <3.2;and remission are <2.6.
Time Frame
108 Weeks
Title
DAS28-CRP(4) <2.6 (ie, Remission) on All Visits After DAS28-CRP(4) <2.6 Was Achieved for Subjects With RA.
Description
The DAS28-CRP(4) is a composite score (ranging from 0 to 9.4) calculated using the results of the TJC (using a 28 joint subset), SJC (using a 28 joint subset), hs-CRP level (mg/L), and SGA (0 to 100 scale). The DAS28-CRP(4) was calculated using the following formula:0.56*sqrt(28TJC) + 0.28*sqrt(28SJC) + 0.36*ln(CRP+1) + 0.014* SGA + 0.96. For DAS28-CRP(4), scores indicating high disease activity are >5.1; low disease activity are <3.2;and remission are <2.6.
Time Frame
48 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have completed 48 weeks of evaluations in CHS-0214-02 and, at Week 48, had at least an ACR20, or completed 48 weeks of evaluations in CHS-0214-04 and, at Week 48, had at least a PASI-50 Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Finck, MD
Organizational Affiliation
Coherus Biosciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Oribe Clinic of Rheumatism and Medicine
City
Oita
State/Province
Ōita Prefecture
ZIP/Postal Code
870-0823
Country
Japan

12. IPD Sharing Statement

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A Long Term Safety Extension Study (CHS-0214-05)

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