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This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1: Sunpharma1505 (Low dose) and Placebo | Experimental |
| |
| Treatment II: Sunpharma1505 (High Dose) and Placebo | Experimental |
| |
| Treatment III: Reference1505 and Placebo | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment I | Drug | Sunpharma1505 and Placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Good/Moderate European League Against Rheumatism Responders | week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Good European League Against Rheumatism -Responders | Day 8 | |
| Good/Moderate European League Against Rheumatism Responders | Day 15 | |
| Good European League Against Rheumatism Responders |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Pharma Site 17 | Brussels | Belgium | ||||
| Sun Pharma Site 18 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment I : Sunpharma1505 (Low Dose) and Placebo | solution for injection/infusion Day 1 and 15 |
| FG001 | Treatment II: Sunpharma1505 (High Dose) and Placebo | solution for injection/infusion Day 1 and 15 |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2018 |
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| Treatment II |
| Drug |
Sunpharma1505 and Placebo |
|
| Treatment III | Drug | Reference1505 and Placebo |
|
| Day 15 |
| Brussels |
| Belgium |
| Sun Pharma Site 21 | Brussels | Belgium |
| Sun Pharma Site 22 | Brussels | Belgium |
| Sun Pharma Site 23 | Brussels | Belgium |
| Sun Pharma Site 16 | Leuven | Belgium |
| Sun Pharma Site 19 | Liège | Belgium |
| Sun Pharma Site 20 | Merksem | Belgium |
| Sun Pharma Site 11 | Amsterdam | Netherlands |
| Sun Pharma Site 9 | Amsterdam | Netherlands |
| Sun Pharma Site 6 | Enschede | Netherlands |
| Sun Pharma Site 4 | Heerlen | Netherlands |
| Sun Pharma Site 7 | Hilversum | Netherlands |
| Sun Pharma Site 2 | Leeuwarden | Netherlands |
| Sun Pharma Site 8 | Lelystad | Netherlands |
| Sun Pharma Site 10 | Rotterdam | Netherlands |
| Sun Pharma Site 3 | Rotterdam | Netherlands |
| Sun Pharma Site 5 | Sneek | Netherlands |
| Sun Pharma Site 14 | Uden | Netherlands |
| Sun pharma Site 01 | Utrecht | Netherlands |
| FG002 | Treatment III: Reference1505 and Placebo | solution for injection/infusion Day 1 and 15 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment I: Sunpharma1505 (Low Dose) and Placebo | solution for injection/infusion Day 1 and 15 |
| BG001 | Treatment II: Sunpharma1505 (High Dose) and Placebo | solution for injection/infusion Day 1 and 15 |
| BG002 | Treatment III: Reference1505 and Placebo | solution for injection/infusion Day 1 and 15 |
| BG003 | 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 |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Good/Moderate European League Against Rheumatism Responders | Intent-to-treat population | Posted | Count of Participants | Participants | No | week 1 |
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| Secondary | Good European League Against Rheumatism -Responders | intent-to-treat | Posted | Count of Participants | Participants | Day 8 |
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| Secondary | Good/Moderate European League Against Rheumatism Responders | Posted | Count of Participants | Participants | Day 15 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Good European League Against Rheumatism Responders | Posted | Count of Participants | Participants | Day 15 |
|
|
Week 12
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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 | Treatment I: Sunpharma1505 (Low Dose) and Placebo | Treatment I: Treatment I and Placebo | 0 | 49 | 4 | 49 | 42 | 49 |
| EG001 | Treatment II: Sunpharma1505 (High Dose) and Placebo | Treatment II: Treatment II and Placebo | 0 | 52 | 1 | 52 | 46 | 52 |
| EG002 | Treatment III: Reference1505 and Placebo | Treatment III: Treatment III and Placebo | 0 | 49 | 2 | 49 | 39 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot flush | Vascular disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hyeprhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Mudgal Kothekar | SPARC | 912266455645 | clinical.trials@sparcmail.com |
| May 2, 2019 |
| Prot_SAP_000.pdf |
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Superiority |
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