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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2009-011621-14 |
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This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIN457 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIN457 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | From Start of the Study up to Study Termination (up to 42 Weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Anti-AIN457 Antibodies | Anti-AIN457 antibodies were assessed in serum. | From Start of the Study up to Study Termination (up to 42 Weeks) |
| Change From Baseline in Concentration of Interleukin 17 (IL-17) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Conneticut Gastroenterology Institute, 39 Brewster Road | Bristol | Connecticut | 06010 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22595313 | Derived | Hueber W, Sands BE, Lewitzky S, Vandemeulebroecke M, Reinisch W, Higgins PD, Wehkamp J, Feagan BG, Yao MD, Karczewski M, Karczewski J, Pezous N, Bek S, Bruin G, Mellgard B, Berger C, Londei M, Bertolino AP, Tougas G, Travis SP; Secukinumab in Crohn's Disease Study Group. Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn's disease: unexpected results of a randomised, double-blind placebo-controlled trial. Gut. 2012 Dec;61(12):1693-700. doi: 10.1136/gutjnl-2011-301668. Epub 2012 May 17. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 7 participants enrolled in the study. All seven participants were discontinued due to early termination of the core study (CAIN457A2202 [NCT00584740]) due to lack of efficacy.
The study was conducted at 6 centers in 3 countries USA, Canada, Poland between 30-August-2009 (first participant enrolled) to 19-August-2010 (Last participant completed).
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab | Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set consisted of all participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab | Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment. |
| 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 | Number of Participants With Adverse Events | Safety analysis set consisted of all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | From Start of the Study up to Study Termination (up to 42 Weeks) |
|
|
From Start of the Study up to Study Termination (up to 42 weeks)
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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 | Secukinumab | Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
The study was terminated early as participants were discontinued prematurely due to early termination of the core trial (CAIN457A2202 [NCT00584740]). This decision was based on fulfillment of the futility criterion for lack of efficacy, assessed during a scheduled interim analysis in the core trial. Therefore, only very limited information is available from this extension study (CAIN457A2202E1 [NCT01009281]).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| D007410 | Intestinal Diseases |
| D004066 | Digestive System Diseases |
| D003967 | Diarrhea |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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| Baseline up to Study Termination (up to 42 Weeks) |
| Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin | Baseline up to Study Termination (up to 42 Weeks) |
| Change From Baseline in C-Reactive Protein Levels | Baseline up to Study Termination (up to 42 Weeks) |
| Maximum (Peak) Observed Steady-State Drug Concentration in the Plasma, Blood, Serum, or Other Body Fluids During Multiple Dosing [Amount x Volume-1] (Cmax,ss) | Pre-dose, post dose on week 44 (end of infusion) |
| Minimum Observed Steady-State Drug Concentration in the Plasma, Blood, Serum, or Other Body Fluids at the End of the Dosing Intervals During Multiple Dosing [Amount x Volume-1] (Cmin,ss) | Pre-dose, post dose on week 44 (end of infusion) |
| Long Island Clinical Research Associates, LLP |
| Great Neck |
| New York |
| 11021 |
| United States |
| Mount Sinai, One Gustave L. Levy Place, Box 1118 | New York | New York | 10029 | United States |
| UNC School of Medicine, Room 7200 MBRB, 103 Mason Farm Road, | Chapel Hill | North Carolina | 27599-7032 | United States |
| Wake Research Asspcoates. ::C. 3100 Duraleigh Road, Suite 304 | Raleigh | North Carolina | 27612 | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
| Secondary | Number of Participants With Anti-AIN457 Antibodies | Anti-AIN457 antibodies were assessed in serum. | Safety analysis set consisted of all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | From Start of the Study up to Study Termination (up to 42 Weeks) |
|
|
|
| Secondary | Change From Baseline in Concentration of Interleukin 17 (IL-17) | Safety analysis set consisted of all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Study Termination (up to 42 Weeks) |
|
|
|
| Secondary | Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin | Safety analysis set consisted of all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Study Termination (up to 42 Weeks) |
|
|
|
| Secondary | Change From Baseline in C-Reactive Protein Levels | Safety analysis set consisted of all participants who received at least one dose of study drug. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | milligram per liter (mg/L) | Baseline up to Study Termination (up to 42 Weeks) |
|
|
|
| Secondary | Maximum (Peak) Observed Steady-State Drug Concentration in the Plasma, Blood, Serum, or Other Body Fluids During Multiple Dosing [Amount x Volume-1] (Cmax,ss) | Pharmacokinetic data analysis included all participants with evaluable pharmacokinetic data. Due to the early discontinuation of all participants, the full dataset of concentration measurements could not be obtained, analyzed and reported. | Posted | Pre-dose, post dose on week 44 (end of infusion) |
|
|
| Secondary | Minimum Observed Steady-State Drug Concentration in the Plasma, Blood, Serum, or Other Body Fluids at the End of the Dosing Intervals During Multiple Dosing [Amount x Volume-1] (Cmin,ss) | Pharmacokinetic data analysis included all participants with evaluable pharmacokinetic data. Due to the early discontinuation of all participants, the full dataset of concentration measurements could not be obtained, analyzed and reported. | Posted | Pre-dose, post dose on week 44 (end of infusion) |
|
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| 0 |
| 7 |
| 0 |
| 7 |
| 3 |
| 7 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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