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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003486-18 | EudraCT Number |
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This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCZ SC 162 mg Q3W | Experimental | Participants with body weight less than (<) 30 kilograms (kg) will be administered 162 milligrams (mg) of TCZ as a SC injection every 3 weeks (Q3W) for 52 weeks. |
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| TCZ SC 162 mg Q2W | Experimental | Participants with body weight greater than or equal to (>/=) 30 kg will be administered 162 mg of TCZ as a SC injection every 2 weeks (Q2W) for 52 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Minimum Serum Concentration (Cmin) of TCZ at Steady State | Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose. | Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section) |
| Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment | Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose. | Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section) |
| Maximum Serum Concentration (Cmax) of TCZ at Steady State | Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose. | Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum Interleukin-6 (IL-6) Levels | IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset. It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity. | Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford | Connecticut | 06106 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33506875 | Derived | Ruperto N, Brunner HI, Ramanan AV, Horneff G, Cuttica R, Henrickson M, Anton J, Boteanu AL, Penades IC, Minden K, Schmeling H, Hufnagel M, Weiss JE, Pardeo M, Nanda K, Roth J, Rubio-Perez N, Hsu JC, Wimalasundera S, Wells C, Bharucha K, Douglass W, Bao M, Mallalieu NL, Martini A, Lovell D, Benedetti F; Paediatric Rheumatology INternational Trials Organisation (PRINTO) and the Paediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis. Rheumatology (Oxford). 2021 Oct 2;60(10):4568-4580. doi: 10.1093/rheumatology/keab047. |
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A total of 52 participants were enrolled in the study. Study included a 21-day screening period.
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| ID | Title | Description |
|---|---|---|
| FG000 | TCZ SC 162 mg Q3W | Participants with body weight less than (<) 30 kilograms (kg) were administered 162 milligrams (mg) of TCZ as an subcutaneous (SC) injection every 3 weeks (Q3W) for 52 weeks. |
| FG001 | TCZ SC 162 mg Q2W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Change From Baseline in Soluble IL-6 Receptor Levels | Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52 |
| Change From Baseline in C-Reactive Protein (CRP) Levels | Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52 |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement. | Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52 |
| Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential | Baseline up to Week 52 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Chicago | Illinois | 60637 | United States |
| Hackensack | New Jersey | 07601 | United States |
| Charlotte | North Carolina | 28203 | United States |
| Durham | North Carolina | 27710 | United States |
| Cincinnati | Ohio | 45229-3039 | United States |
| Tulsa | Oklahoma | 74135 | United States |
| Salt Lake City | Utah | 84109 | United States |
| Seattle | Washington | 98105 | United States |
| Buenos Aires | 1270 | Argentina |
| Westmead | New South Wales | 2145 | Australia |
| Parkville | Victoria | 3052 | Australia |
| Rio de Janeiro | Rio de Janeiro | 20551-030 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 21941-912 | Brazil |
| São Paulo | São Paulo | 05403-000 | Brazil |
| São Paulo | São Paulo | 22793-080 | Brazil |
| Calgary | Alberta | T3B 6A8 | Canada |
| Ottawa | Ontario | K1H 8L1 | Canada |
| Toronto | Ontario | M5G 1X8 | Canada |
| Le Kremlin-Bicêtre | 94275 | France |
| Berlin | 13353 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Sankt Augustin | 53757 | Germany |
| Rome | Lazio | 00165 | Italy |
| Genoa | Liguria | 16147 | Italy |
| Florence | Tuscany | 50139 | Italy |
| Monterrey | 64460 | Mexico |
| Moscow | 115522 | Russia |
| Moscow | 119991 | Russia |
| Esplugas de Llobregat | Barcelona | 08950 | Spain |
| Madrid | 28034 | Spain |
| Madrid | 28046 | Spain |
| Bristol | BS2 8BJ | United Kingdom |
| Liverpool | L12 2AP | United Kingdom |
Participants with body weight greater than or equal to (>/=) 30 kg were administered 162 mg of TCZ as an SC injection every 2 weeks (Q2W) for 52 weeks.
| COMPLETED |
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| NOT COMPLETED |
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Safety population included all participants who received at least one dose of treatment and who had at least one post-dose safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | TCZ SC 162 mg Q3W | Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks. |
| BG001 | TCZ SC 162 mg Q2W | Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Minimum Serum Concentration (Cmin) of TCZ at Steady State | Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose. | Pharmacokinetic population included all enrolled participants who were adherent to the protocol. | Posted | Median | Full Range | Micrograms/milliliter (mcg/mL) | Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section) |
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| Primary | Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment | Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose. | Pharmacokinetic population. | Posted | Mean | Full Range | mcg*day/mL | Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section) |
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| Primary | Maximum Serum Concentration (Cmax) of TCZ at Steady State | Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose. | Pharmacokinetic population | Posted | Median | Full Range | mcg/mL | Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section) |
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| Secondary | Change From Baseline in Serum Interleukin-6 (IL-6) Levels | IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset. It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity. | Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category. | Posted | Mean | Standard Deviation | picograms/milliliter (pg/mL) | Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52 |
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| Secondary | Change From Baseline in Soluble IL-6 Receptor Levels | Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52 |
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| Secondary | Change From Baseline in C-Reactive Protein (CRP) Levels | Safety population. Number Analyzed represents participants evaluable for the specified category. | Posted | Mean | Standard Deviation | mg/L | Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52 |
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| Secondary | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement. | Safety population. Number Analyzed represents participants evaluable for the specified category. | Posted | Mean | Standard Deviation | millimeters per hour (mm/h) | Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52 |
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| Secondary | Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential | Safety population. | Posted | Number | percentage of participants | Baseline up to Week 52 |
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Baseline up to Week 56
Safety population
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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 | TCZ SC 162 mg Q3W | Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks. | 1 | 27 | 23 | 27 | ||
| EG001 | TCZ SC 162 mg Q2W | Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks. | 2 | 25 | 22 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Croup infectious | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Varicella | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Ear Pain | Ear and labyrinth disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Aphthous Ulcer | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Injection Site Erythema | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Injection Site Haematoma | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Injection Site Pruritus | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Vessel Puncture Site Haematoma | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Ear Infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Impetigo | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Nasophryngitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Otitis Media | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Viral Infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Juvenile Idiopathic Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Skin Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| 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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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| Male |
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