Trial Outcomes & Findings for A Long Term Safety Extension Study (CHS-0214-05) (NCT NCT02486939)

Last Updated: 2018-12-27

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

359 participants

Primary outcome timeframe

48 Weeks

Results posted on

2018-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	CHS-0214-02 -RA RA Participants	CHS-0214-04 - PsO PsO Participants
Overall Study STARTED	225	134
Overall Study COMPLETED	224	132
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CHS-0214-02-RA n=224 Participants RA Participants	CHS-0214-04-PsO n=132 Participants PsO Participants	Total n=356 Participants Total of all reporting groups
Age, Continuous	52.2 years STANDARD_DEVIATION 11.28 • n=5 Participants	45.9 years STANDARD_DEVIATION 13.2 • n=7 Participants	49.9 years STANDARD_DEVIATION 12.36 • n=5 Participants
Sex: Female, Male Female	170 Participants n=5 Participants	31 Participants n=7 Participants	201 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	101 Participants n=7 Participants	155 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	222 Participants n=5 Participants	128 Participants n=7 Participants	350 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	167 Participants n=5 Participants	9 Participants n=7 Participants	176 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	108 Participants n=7 Participants	158 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Height	162.1 Centimeters STANDARD_DEVIATION 8.7 • n=5 Participants	172.2 Centimeters STANDARD_DEVIATION 10.71 • n=7 Participants	165.9 Centimeters STANDARD_DEVIATION 10.83 • n=5 Participants
Weight	65.58 Kilograms STANDARD_DEVIATION 17.604 • n=5 Participants	92.19 Kilograms STANDARD_DEVIATION 21.593 • n=7 Participants	75.58 Kilograms STANDARD_DEVIATION 23.599 • n=5 Participants
BMI (Body Mass Index)	24.73 "kg/m^2" STANDARD_DEVIATION 5.287 • n=5 Participants	31.06 "kg/m^2" STANDARD_DEVIATION 7.238 • n=7 Participants	27.09 "kg/m^2" STANDARD_DEVIATION 6.823 • n=5 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Outcome measures

Outcome measures
Measure	CHS-0214-02 -RA n=224 Participants RA Participants
Durability of Response (Maintenance of an ACR20 Response or Greater), Which Was Measured at Each Visit in Subjects of RA	117 Participants

PRIMARY outcome

Timeframe: Week 0,4,12,24,36,48

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.

Outcome measures

Outcome measures
Measure	CHS-0214-02 -RA n=132 Participants RA Participants
In Subjects With PsO, Durability of Response (Maintenance of PASI-50 Response or Greater), Which Was Measured at Each Visit.	94 Participants

SECONDARY outcome

Timeframe: 108 Weeks

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.

Outcome measures

Outcome measures
Measure	CHS-0214-02 -RA n=224 Participants RA Participants
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. Week 24	189 participants
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. Week 4	192 participants
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. Week 12	190 participants
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. Week 36	188 participants
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. Week 48	184 participants
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. Week 60	139 participants
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. Week 72	140 participants
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. Week 84	121 participants
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. Week 96	48 participants
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. Week 108	34 participants
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. Follow Up Visit	5 participants

SECONDARY outcome

Timeframe: 48 Weeks

Outcome measures

Outcome measures
Measure	CHS-0214-02 -RA n=224 Participants RA Participants
DAS28-CRP(4) <2.6 (ie, Remission) on All Visits After DAS28-CRP(4) <2.6 Was Achieved for Subjects With RA.	135 Participants

Adverse Events

CHS-0214-02-RA

Serious events: 18 serious events

Other events: 117 other events

Deaths: 1 deaths

CHS-0214-04-PsO

Serious events: 7 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	CHS-0214-02-RA n=224 participants at risk RA Participants	CHS-0214-04-PsO n=132 participants at risk PsO Participants
Infections and infestations Bronchitis	6.7% 15/224 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.	0.76% 1/132 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.
Infections and infestations Influenza	6.7% 15/224 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.	6.8% 9/132 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.
Infections and infestations Pharyngitis	5.8% 13/224 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.	1.5% 2/132 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.
Infections and infestations Upper Respiratory Infection	9.4% 21/224 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.	12.1% 16/132 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.
Infections and infestations Urinary Tract Infection	5.8% 13/224 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.	2.3% 3/132 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.
Gastrointestinal disorders Stomatitis	6.2% 14/224 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.	0.00% 0/132 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.
Musculoskeletal and connective tissue disorders Back Pain	6.2% 14/224 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.	0.00% 0/132 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.
Injury, poisoning and procedural complications Contusion	5.4% 12/224 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.	2.3% 3/132 • Adverse event data was collected starting on Day 0 and collected at Day 28 (Week 4), Day 84 (Week 12), Day 168 (Week 24), Day 252 (Week 36), Day 336 (Week 48) and Day 364 or 28 days post last dose (Week 52 or 4 weeks post last dose) for subjects with rheumatoid arthritis and plaque psoriasis. Adverse events related to study drug injection sites were assessed at each visit and recorded by subjects in the eDiary following each injection through Week 48.

Additional Information

Barbara K. Finck, MD Chief Medical Officer

Coherus BioSciences, Inc

Phone: 650-649-3529

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place