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This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in patients with psoriatic arthritis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in psoriatic arthritis a decision will be made as to whether or not to continue dosing for another 6 month period (Part 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIN457/AIN457 3 mg/kg. | Experimental | Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks. |
|
| Placebo/AIN457 3 mg/kg. | Placebo Comparator | Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIN457A | Biological |
| ||
| Other |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events and Serious Adverse Events | Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. | Up to 64 weeks (End of the Study Treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Total IL-17 Concentration in Blood at Steady-state | Total IL-17 concentration was not reported due to assay limitations. | Up to 64 weeks |
| Mean Serum Concentration Measured at Steady State | This outcome measure is assessing AIN457 Mean Serum Concentration Measured at Steady State. A competitive ELISA method was used for bioanalytical analyses and the anticipated LLOQ is 80 nanograms/mL serum. |
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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 |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Hamburg | 22415 | Germany | |||
| Novartis Investigative Site |
A total of 42 patients were randomized in the (CAIN457A2206) core study, of which 28 patients enrolled into the (CAIN457A2206E1) extension study.
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| ID | Title | Description |
|---|---|---|
| FG000 | AIN457/AIN457 3 mg/kg. | Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks. |
| FG001 | Placebo/AIN457 3 mg/kg | Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AIN457/AIN457 3 mg/kg | Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks. |
| BG001 | Placebo/AIN457 3 mg/kg |
| 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 and Serious Adverse Events | Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. | The safety population consisted of all randomized patients who received at least one dose of the study drug. | Posted | Count of Participants | Participants | Up to 64 weeks (End of the Study Treatment) |
|
Adverse events were collected from first dose of study treatment until end of study treatment (Week 52), and continued up to Week 64
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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 | AIN457/AIN457 3 mg/kg | Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | +1 (862) 778-8300 | Novartis.email@novartis.com |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| Other |
|
| Weeks 0, 8, 16, 20, 24, 28, 32, 36, 40 and at 4 and 12 weeks after the last administration at Week 52. |
| Amsterdam |
| DE |
| 1100 |
| Netherlands |
| Novartis Investigative Site | Meerssen | KR | 6231 | Netherlands |
| Novartis Investigative Site | Glasgow | G12 8TA | United Kingdom |
| Novartis Investigative Site | Leeds | LS7 4SA | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | NE2 4HH | United Kingdom |
| Unsatisfactory therapeutic effect |
|
Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
| OG001 | Placebo/AIN457 3 mg/kg | Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks. |
|
|
| Secondary | Total IL-17 Concentration in Blood at Steady-state | Total IL-17 concentration was not reported due to assay limitations. | No participants were evaluated as IL-17 concentration was not reported due to assay limitations | Posted | Up to 64 weeks |
|
|
| Secondary | Mean Serum Concentration Measured at Steady State | This outcome measure is assessing AIN457 Mean Serum Concentration Measured at Steady State. A competitive ELISA method was used for bioanalytical analyses and the anticipated LLOQ is 80 nanograms/mL serum. | All participants from the safety set with quantifiable pharmacokinetic (PK) measurements and no major protocol deviations with impact on PK data were included in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | Microgram/millilitre (μg/mL) | Weeks 0, 8, 16, 20, 24, 28, 32, 36, 40 and at 4 and 12 weeks after the last administration at Week 52. |
|
|
|
| 0 |
| 19 |
| 5 |
| 19 |
| 19 |
| 19 |
| EG001 | Placebo/AIN457 3 mg/kg | Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks. | 0 | 9 | 2 | 9 | 9 | 9 |
| Viral sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Change of bowel habit | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Thirst | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood immunoglobulin G increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Overweight | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Epididymitis | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Skin warm | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Raynaud's phenomenon | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| 0/post-inf |
|
|
| 8/pre-inf |
|
|
| 8 /post-inf |
|
|
| 16/pre-inf |
|
|
| 16/post-inf |
|
|
| 20/pre-inf |
|
|
| 20/post-inf |
|
|
| 24/pre-inf |
|
|
| 24/post-inf |
|
|
| 28/pre-inf |
|
|
| 28/post-inf |
|
|
| 32/pre-inf |
|
|
| 32/post-inf |
|
|
| 36/pre-inf |
|
|
| 36/post-inf |
|
|
| 40/pre-inf |
|
|
| 40/post-inf |
|
|
| 56 |
|
|
| 64 |
|
|