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

Rheumatoid Arthritis Clinical Trial

Official title:

An Open-Label Safety Extension Study (OLSES) Evaluating the Long Term Safety and Durability of Response of CHS-0214 (CHS-0214-05)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486939
• Other study ID #: CHS-0214-05
• Status: Completed
• Phase: Phase 3
• Start date: July 2015
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: Coherus Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: October 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Plaque Psoriasis
• Psoriasis
• Rheumatoid Arthritis

Intervention

Drug:
• CHS-0214
Open label

Locations

Country	Name	City	State
Japan	Oribe Clinic of Rheumatism and Medicine	Oita	Oita Prefecture

Sponsors (3)

Lead Sponsor	Collaborator
Coherus Biosciences, Inc.	Daiichi Sankyo Co., Ltd., Shire

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	48 Weeks
Primary	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.	Week 0,4,12,24,36,48
Secondary	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.	108 Weeks
Secondary	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.	48 Weeks