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| Name | Class |
|---|---|
| Daiichi Sankyo Co., Ltd. | INDUSTRY |
| Shire | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHS-0214 | Experimental | CHS-0214 50 mg weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHS-0214 | Drug | Open label |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Finck, MD | Coherus Oncology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oribe Clinic of Rheumatism and Medicine | ÅŒita | Oita Prefecture | 870-0823 | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | CHS-0214-02 -RA | RA Participants |
| FG001 | CHS-0214-04 - PsO | PsO Participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CHS-0214-02-RA | RA Participants |
| BG001 | CHS-0214-04-PsO | PsO Participants |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | 48 Weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CHS-0214-02-RA | RA Participants | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes Zoster | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara K. Finck, MD Chief Medical Officer | Coherus BioSciences, Inc | 650-649-3529 | Bfinck@coherus.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 29, 2016 | Oct 30, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 25, 2017 | Oct 30, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 108 Weeks |
| 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 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | Centimeters |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
| BMI (Body Mass Index) | Mean | Standard Deviation | "kg/m^2" |
|
| OG000 |
| CHS-0214-02 -RA |
RA Participants |
|
|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Number | participants | 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. | Posted | Count of Participants | Participants | 48 Weeks |
|
|
|
| 224 |
| 18 |
| 224 |
| 117 |
| 224 |
| EG001 | CHS-0214-04-PsO | PsO Participants | 0 | 132 | 7 | 132 | 34 | 132 |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Pulmonary Tuberculosis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cerebral Infarction | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Temporal Lobe Epilepsy | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
|
| Arrythmia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
|
| Spondylotlisthesis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cystocele | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
|
| Aortic Aneurysm | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Umbilical Hernia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|
|
| Week 36 |
|
| Week 48 |
|
| Week 60 |
|
| Week 72 |
|
| Week 84 |
|
| Week 96 |
|
| Week 108 |
|
| Follow Up Visit |
|