Brief Summary
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.
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.
Brief Title
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)
Completion Date
Completion Date Type
Actual
Conditions
Rheumatoid Arthritis
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
CHS-0214
Enbrel
RA
Biosimilar
Etanercept
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02115750
Org Class
Industry
Org Full Name
Coherus Biosciences, Inc.
Org Study Id
CHS-0214-02
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate
Primary Outcomes
Outcome Description
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)
Outcome Measure
ACR-20 - 20% Improvement According to American College of Rheumatology Criteria
Outcome Time Frame
24-weeks
Secondary Outcomes
Outcome Description
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).
* 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).
Outcome Time Frame
Weeks 4, 8, 12 and 18
Outcome Measure
ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18
Outcome Description
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.
Outcome Time Frame
Weeks 4,8,12,18,24,28,36,48
Outcome Measure
Summary of Change in Tender Joint Count (TJC) by Study Visit
Outcome Description
The 66/68 Joint Count evaluates 66 joints for swelling. 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.
Outcome Time Frame
Weeks 4,8,12,18,24,28,36,48
Outcome Measure
Summary of Change in Swollen Joint Count (SJC) by Study Visit
Outcome Description
HAQ-DI - Scales for each question range from 0-3 (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=Unable to do). The "total" for each category is determined by the highest score (greatest difficulty) for that category. The score for the disability index is the mean of the eight category scores. If more than 2 of the categories or 25% are missing, the scale won't be scored. If fewer than 2 or the categories are missing, the sum of the categories was divided by the number of answered categories.
Outcome Time Frame
Weeks 4,8,12,18,24,28,36,48
Outcome Measure
Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit
Outcome Description
The score range for the SPA-VAS is 0-100 millimeters. One total score was reported for each assessment, no subscales exist. A lower score on the left side represents a better outcome (less pain) and the higher score is on the right side representing a worse outcome (more pain).
Outcome Time Frame
Weeks 4,8,12,18,24,28,36,48
Outcome Measure
Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit
Outcome Description
The score range for PGA-VAS is 0-100 millimeters. The patient's assessment of disease activity - with the lowest score on the left side representing "none" to the highest score on the right side representing "extremely active".
Outcome Time Frame
Weeks 4,8,12,18,24,28,36,48
Outcome Measure
Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Clement Tagoe
Investigator Email
ctagoe@montefiore.org
Investigator Phone