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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003719-23 | EudraCT Number |
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A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A - SAN-300 0.5 mg/kg QW | Experimental | SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks |
|
| Cohort B - SAN-300 1.0 mg/kg QW | Experimental | SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks |
|
| Cohort C - SAN-300 2.0 mg/kg QOW | Experimental | SAN-300 2.0 mg/kg subcutaneous every other week for six weeks |
|
| Cohort D - SAN-300 4.0 mg/kg QOW | Experimental | SAN-300 4.0 mg/kg subcutaneous every other week for six weeks |
|
| Cohort E - SAN-300 4.0 mg/kg QW | Experimental | SAN-300 4.0 mg/kg subcutaneous every other week for six weeks |
|
| Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAN-300 0.5 mg/kg QW | Drug |
| ||
| SAN-300 1.0 mg/kg QW |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP) | DAS28-CRP= 0.56 x sqrt(TJC28) x sqrt(SJC28) + 0.36 x ln(CRP+1) +0.014 x VAS +0.96 Where TJC28: The number of tender joints (0-28). SJC28: The number of swollen joints (0-28). CRP: The C-Reactive Protein level (in mg/l). VAS General Health Assessment (from 0=best to 100=worst). ln=natural log. sqrt = square root. Higher scores indicate worse outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Health Assessment Questionnaire-Disease Index (HAQ-DI) | HAQ assesses the degree of difficulty a participant has had in accomplishing tasks in eight functional areas, over the previous week.
(0), with SOME difficulty (1), with MUCH difficulty (2) and UNABLE to do (3). Scores for each of the eight categories are calculated. HAQ is calculated by adjusting the score for each of these categories, if necessary, based upon the patient's use of an aid, device, or assistance for that category, totaling the sum of the category scores and dividing by the number of categories answered. HAQ can range from 0 to 3. Higher scores (greater level of difficulty) indicate worse outcome. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santarus Clinical Investigational Site 1012 | Phoenix | Arizona | 85023 | United States | ||
| Santarus Clinical Investigational Site 1004 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A - SAN-300 0.5 mg/kg QW | SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks |
| FG001 | Cohort B - SAN-300 1.0 mg/kg QW | SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 28, 2016 | Sep 13, 2019 |
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Placebo dosing
|
| Drug |
|
| SAN-300 2.0 mg/kg QOW | Drug |
|
| SAN-300 4.0 mg/kg QOW | Drug |
|
| SAN-300 4.0 mg/kg QW | Drug |
|
| Placebo | Drug |
|
| Baseline, End of Treatment Visit (Week 7) |
| Number of Participants With American College of Rheumatology 20 (ACR20) Response. | A participant is considered to have an ACR20 response if there is an improvement of 20% in all of the following:
| End of Treatment Visit (Week 7) |
| Baseline, End of Treatment Visit (Week 7) |
| Bone Erosion Detected Using Magnetic Resonance Imaging (MRI) Findings of the Hand and Wrist - Change From Baseline | Bone Erosion detected by MRI of hand/wrist was scored using the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA MRI scoring (RAMRIS) system. Bone erosion was scored 0-10, according to the proportion (in increments of 10%) of erosion of articular bone: 0: 0%, 1: 1%-10%, 2: 11%-20%, ……..10: 91%-100%. Higher scores (more erosion) indicate worse outcome. | Baseline, End of Treatment Visit (Week 7) |
| El Cajon |
| California |
| 92020 |
| United States |
| Santarus Clinical Investigational Site 1008 | Los Angeles | California | 90048 | United States |
| Santarus Clinical Investigational Site 1011 | San Leandro | California | 94578 | United States |
| Santarus Clinical Investigational Site 1013 | Brandon | Florida | 33511 | United States |
| Santarus Clinical Investigational Site 1003 | Palm Harbor | Florida | 34684 | United States |
| Santarus Clinical Investigational Site 1017 | Florissant | Missouri | 63031 | United States |
| Santarus Clinical Investigational Site 1009 | Brooklyn | New York | 11201 | United States |
| Santarus Clinical Investigational Site 1019 | Chapel Hill | North Carolina | 27599 | United States |
| Santarus Clinical Investigational Site 1014 | Charlotte | North Carolina | 28210 | United States |
| Santarus Clinical Investigational Site 1006 | Salisbury | North Carolina | 28144 | United States |
| Santarus Clinical Investigational Site 1001 | Middleburg Heights | Ohio | 44130 | United States |
| FG002 | Cohort C - SAN-300 2.0 mg/kg QOW | SAN-300 2.0 mg/kg subcutaneous every other week for six weeks |
| FG003 | Cohort D - SAN-300 4.0 mg/kg QOW | SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks |
| FG004 | Cohort E - SAN-300 4.0 mg/kg QW | SAN-300 4.0 mg/kg subcutaneous every week for six weeks |
| FG005 | Placebo | Placebo dosing |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A - SAN-300 0.5 mg/kg QW | SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks |
| BG001 | Cohort B - SAN-300 1.0 mg/kg QW | SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks |
| BG002 | Cohort C - SAN-300 2.0 mg/kg QOW | SAN-300 2.0 mg/kg subcutaneous every other week for six weeks |
| BG003 | Cohort D - SAN-300 4.0 mg/kg QOW | SAN-300 4.0 mg/kg subcutaneous every other week for six weeks |
| BG004 | Cohort E - SAN-300 4.0 mg/kg QW | SAN-300 4.0 mg/kg subcutaneous once weekly for six weeks |
| BG005 | Placebo | Placebo dosing |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Number of Participants With Adverse Events | Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up. | Posted | Count of Participants | Participants | 10 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP) | DAS28-CRP= 0.56 x sqrt(TJC28) x sqrt(SJC28) + 0.36 x ln(CRP+1) +0.014 x VAS +0.96 Where TJC28: The number of tender joints (0-28). SJC28: The number of swollen joints (0-28). CRP: The C-Reactive Protein level (in mg/l). VAS General Health Assessment (from 0=best to 100=worst). ln=natural log. sqrt = square root. Higher scores indicate worse outcome. | Posted | Mean | Standard Error | units on a scale | Baseline, End of Treatment Visit (Week 7) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With American College of Rheumatology 20 (ACR20) Response. | A participant is considered to have an ACR20 response if there is an improvement of 20% in all of the following:
| Posted | Count of Participants | Participants | End of Treatment Visit (Week 7) |
| ||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in the Health Assessment Questionnaire-Disease Index (HAQ-DI) | HAQ assesses the degree of difficulty a participant has had in accomplishing tasks in eight functional areas, over the previous week.
(0), with SOME difficulty (1), with MUCH difficulty (2) and UNABLE to do (3). Scores for each of the eight categories are calculated. HAQ is calculated by adjusting the score for each of these categories, if necessary, based upon the patient's use of an aid, device, or assistance for that category, totaling the sum of the category scores and dividing by the number of categories answered. HAQ can range from 0 to 3. Higher scores (greater level of difficulty) indicate worse outcome. | Posted | Mean | Standard Error | units on a scale | Baseline, End of Treatment Visit (Week 7) |
| |||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Bone Erosion Detected Using Magnetic Resonance Imaging (MRI) Findings of the Hand and Wrist - Change From Baseline | Bone Erosion detected by MRI of hand/wrist was scored using the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA MRI scoring (RAMRIS) system. Bone erosion was scored 0-10, according to the proportion (in increments of 10%) of erosion of articular bone: 0: 0%, 1: 1%-10%, 2: 11%-20%, ……..10: 91%-100%. Higher scores (more erosion) indicate worse outcome. | Posted | Mean | Standard Error | units on a scale | Baseline, End of Treatment Visit (Week 7) |
|
Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
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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 | Cohort A - SAN-300 0.5 mg/kg QW | SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks | 0 | 6 | 0 | 6 | 1 | 6 |
| EG001 | Cohort B - SAN-300 1.0 mg/kg QW | SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks | 0 | 7 | 0 | 7 | 1 | 7 |
| EG002 | Cohort C - SAN-300 2.0 mg/kg QOW | SAN-300 2.0 mg/kg subcutaneous every other week for six weeks | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | Cohort D - SAN-300 4.0 mg/kg QOW | SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks | 0 | 6 | 2 | 6 | 6 | 6 |
| EG004 | Cohort E - SAN-300 4.0 mg/kg QW | SAN-300 4.0 mg/kg subcutaneous every week for six weeks | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | Placebo | Placebo dosing | 0 | 10 | 0 | 10 | 3 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| diarrheoa | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Mouth Ulcerations | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Injection Site Rash | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Blood Pressure Increase | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Electrocardiogram Abnormal | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headaches | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Services | Valeant Pharmaceuticals | 9089271162 | christine.hnatko@valeant.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2017 | Sep 13, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG004 | Cohort E - SAN-300 4.0 mg/kg QW | SAN-300 4.0 mg/kg subcutaneous every week for six weeks |
| OG005 | Placebo | Placebo dosing |
|
|
| OG004 | Cohort E - SAN-300 4.0 mg/kg QW | SAN-300 4.0 mg/kg subcutaneous every week for six weeks |
| OG005 | Placebo | Placebo dosing |
|
|
SAN-300 2.0 mg/kg subcutaneous every other week for six weeks |
| OG003 | Cohort D - SAN-300 4.0 mg/kg QOW | SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks |
| OG004 | Cohort E - SAN-300 4.0 mg/kg QW | SAN-300 4.0 mg/kg subcutaneous every week for six weeks |
| OG005 | Placebo | Placebo dosing |
|
|
| OG004 | Cohort E - SAN-300 4.0 mg/kg QW | SAN-300 4.0 mg/kg subcutaneous every week for six weeks |
| OG005 | Placebo | Placebo dosing |
|
|