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The purpose of this study was to assess the efficacy and safety of secukinumab in Chinese participants with active Psoriatic arthritis (PsA ) compared to placebo.
This study used a randomized, double-blind, placebo-controlled, parallel-group design.
A screening period running up to 10 weeks before randomization was used to assess participant eligibility followed by 52 weeks of treatment.
A follow-up visit was done 12 weeks after last study treatment administration for all participants, regardless of whether they completed the entire study as planned or discontinued prematurely.
At Baseline, the patients fulfilling the inclusion criteria were randomized to one of the following two groups.
Group 1 : Secukinumab Dose level 1 s.c. at BSL, Week 1, 2, 3, 4, 8, and 12 Group 2 : Secukinumab Placebo s.c. at BSL, Week 1, 2, 3, 4, 8, and 12.
At Week 16, participants in Group 1 and Group 2 were to be re-randomized separately in a 1:1 ratio to receive secukinumab 150 mg or secukinumab 300 mg.
The duration of the entire treatment period was 52 weeks.
The primary objective was to demonstrate the treatment effect of secukinumab in Chinese subjects with active PsA by assessing American College of Rheumatology rresponse 20 (ACR20 response) rates at Week 16.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Participants received 150 mg dose (dose level 1) of Secukinumab |
|
| Arm 2 | Placebo Comparator | Participants received Placebo of the study drug. |
|
| Arm 3 | Active Comparator | Participants who received Placebo and switched to dose level 1 (150 mg) of secukinumab. |
|
| Arm 4 | Active Comparator | Participants who received Placebo and switched to dose level 2 (300 mg) of secukinumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIN457 | Drug | Secukinumab 150 mg was supplied in 1.0 mL prefilled syringe, administered via subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 Response at Week 16 | Assessed the efficacy of secukinumab relative to placebo at week 16 using Non-responder imputation (NRI) and based on the percentage of participants achieving an ACR20 response (ACR = American College of Rheumatology). ACR20 response criteria is response ≥ 20% improvement based on: Swollen Joint Count (SJC)/Tender Joint Count (TJC), Patient's global assessment of disease activity (PaGA) (Visual Analog Scale (VAS)), Physician's global assessment of disease activity (PhGA) (VAS), Patient's assessment of PsA pain intensity (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), and High-sensitivity C-reactive protein (hsCRP) or Erythrocyte sedimentation rate (ESR). | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ACR50 Response at Week 16 | To assess the effect of secukinumab versus placebo on the composite endpoint ACR50 response and based on the percentage of participants achieving an ACR50 response at Week 16 using NRI. ACR50 response criteria is response ≥ 50% improvement based on: Swollen Joint Count (SJC)/Tender Joint Count (TJC), Patient's global assessment of disease activity (PaGA) (VAS), Physician's global assessment of disease activity (PhGA) (VAS), Patient's assessment of PsA pain intensity (VAS), HAQ-DI, and hsCRP or ESR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Chongqing | Chongqing Municipality | 400010 | China | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novctrd.com | View source |
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Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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This study was conducted in 12 centers in China.
In the 1st 16 weeks of study, the 41 participants enrolled were randomized to 2 groups: 1 group received secukinumab 150 mg & the other received placebo. At week 16, the participants were re-randomized within each group for a total of 4 groups. Within the secukinumab group, 1 group continued to receive secukinumab 150 mg while the other half received secukinumab 300 mg. In the Placebo group, 1 group switched to secukinumab 150 mg while the other half switched to secukinumab 300 mg.
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab 150 mg (Group 1) | Participants received 150 mg dose (dose level 1) of Secukinumab |
| FG001 | Placebo of Study Drug (Group 2) | Participants received Placebo of the study drug |
| FG002 | Secukinumab 150 mg to Secukinumab 150 mg (2nd Randomization) | Participants who had previously received Secukinumab 150 mg dose (dose level 1) continued receiving 150 mg dose (dose level 1) of Secukinumab |
| FG003 | Secukinumab 150 mg to Secukinumab 300 mg (2nd Randomization) | Participants who had previously received Secukinumab 150 mg dose (dose level 1) now received 300 mg dose (dose level 2) of Secukinumab |
| FG004 | Placebo to Secukinumab 150 mg (2nd Randomization) | Participants who had previously received Placebo switched to Secukinumab 150 mg (dose level 1) |
| FG005 | Placebo to Secukinumab 300 mg (2nd Randomization) | Participants who had previously received Placebo switched to Secukinumab 300 mg (dose level 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (1st 16 Weeks) |
| |||||||||||||
| Treatment Period 2 (From Week 16) |
|
Randomized set: All participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab 150 mg (Group 1) | Participants received 150 mg dose (dose level 1) of Secukinumab |
| BG001 | Placebo of Study Drug (Group 2) | Participants received Placebo of the study drug |
| 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 | ACR20 Response at Week 16 | Assessed the efficacy of secukinumab relative to placebo at week 16 using Non-responder imputation (NRI) and based on the percentage of participants achieving an ACR20 response (ACR = American College of Rheumatology). ACR20 response criteria is response ≥ 20% improvement based on: Swollen Joint Count (SJC)/Tender Joint Count (TJC), Patient's global assessment of disease activity (PaGA) (Visual Analog Scale (VAS)), Physician's global assessment of disease activity (PhGA) (VAS), Patient's assessment of PsA pain intensity (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), and High-sensitivity C-reactive protein (hsCRP) or Erythrocyte sedimentation rate (ESR). | Full Analysis Set (FAS): All participants from the randomized set to whom study treatment had been assigned. | Posted | Count of Participants | Participants | 16 weeks |
|
Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 52 weeks.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
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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 | Any AIN457 150 mg | Participants who received Secukinumab 150 mg dose (dose level 1) at any point during the trial. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
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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 | Nov 16, 2020 | Feb 7, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2023 | Feb 7, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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| Secukinumab Placebo | Other | Secukinumab placebo was supplied in 1.0 mL prefilled syringe, administered via subcutaneous injection |
|
| 16 weeks |
| Change From Baseline in DAS28-CRP Scores Using Mixed Model Repeated Scores (MMRM) at Week 16 | To assess the effect of secukinumab versus placebo on change from BSL in DAS28-CRP. The assessment is based on the reduction in DAS28-CRP score. The DAS28 is a measure of disease activity based on Swollen and Tender Joint Counts, ESR or CRP and the Patient Global Assessment of Disease Activity. The range of DAS28 score is 0-10. Higher score means more active disease. Negative change from baseline indicates a favorable outcome. | 16 weeks |
| Change From Baseline in PASDAS Scores Using MMRM at Week 16 | To assess the the effect of secukinumab versus placebo on change from Baseline in PASDAS. Assessment was based on reduction in PASDAS score. PASDAS is a measure of disease activity based on Patient reported measures (excluding mental component score (MCS) of the medical outcomes survey Short Form-36 (SF-36-PCS)), skin, peripheral joint counts (Tender and Swollen joint counts), Dactylitis (LDI), Enthesitis (LEI), acute phase response (CRP) and Patient & Physician global VAS scores. The range of PASDAS is 0-10. Higher score means more active disease. Negative change from baseline indicates a favorable outcome. | 16 weeks |
| Change From Baseline in SF36-PCS Scores Using MMRM at Week 16 | To assess the effect of secukinumab versus placebo on change from Baseline in SF-36 PCS. The SF-36 is a widely used and extensively studied instrument to measure HRQoL among healthy participants and participants with acute and chronic conditions. Two overall summary scores, the Physical Component Score (PCS) and the Mental Component Score (MCS) also can be computed. SF36-PCS was used in this study. The range of SF36-PCS score is 0-100. Higher score means better health status. Negative change from baseline indicates a unfavorable outcome. | 16 weeks |
| Change From Baseline in HAQ-DI Scores Using MMRM at Week 16 | To assess the effect of secukinumab versus placebo on change from Baseline in HAQ-DI. Assessment was based on improvement in HAQ-DI PCS scores. The HAQ-DI© is one of the most widely used measures to assess the long-term influence of chronic disease on a participant's level of functional ability and activity restriction, and calculated based on HAQ-DI questionnaire. There are 20 questions in eight categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The range of score is 0-3. Higher score means more severe disability. Negative change from baseline indicates a favorable outcome. | 16 weeks |
| Guangzhou |
| Guangdong |
| 510120 |
| China |
| Novartis Investigative Site | Zhuzhou | Hunan | 412000 | China |
| Novartis Investigative Site | Baotou | Inner Mongolia | 014010 | China |
| Novartis Investigative Site | Hohhot | Inner Mongolia | 10050 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210008 | China |
| Novartis Investigative Site | Nanchang | Jiangxi | 330006 | China |
| Novartis Investigative Site | Pingxiang | Jiangxi | 337000 | China |
| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Beijing | 100730 | China |
| Novartis Investigative Site | Jinan | 250012 | China |
| Novartis Investigative Site | Shanghai | 200127 | China |
| Discont. From Treatment Before Week 52 |
|
| Completed Study Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
Participants received 150 mg dose (dose level 1) of Secukinumab
| OG001 | Placebo of Study Drug (Group 2) | Participants received Placebo of the study drug |
|
|
|
| Secondary | ACR50 Response at Week 16 | To assess the effect of secukinumab versus placebo on the composite endpoint ACR50 response and based on the percentage of participants achieving an ACR50 response at Week 16 using NRI. ACR50 response criteria is response ≥ 50% improvement based on: Swollen Joint Count (SJC)/Tender Joint Count (TJC), Patient's global assessment of disease activity (PaGA) (VAS), Physician's global assessment of disease activity (PhGA) (VAS), Patient's assessment of PsA pain intensity (VAS), HAQ-DI, and hsCRP or ESR. | Full Analysis Set (FAS): All participants from the randomized set to whom study treatment had been assigned. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
|
| Secondary | Change From Baseline in DAS28-CRP Scores Using Mixed Model Repeated Scores (MMRM) at Week 16 | To assess the effect of secukinumab versus placebo on change from BSL in DAS28-CRP. The assessment is based on the reduction in DAS28-CRP score. The DAS28 is a measure of disease activity based on Swollen and Tender Joint Counts, ESR or CRP and the Patient Global Assessment of Disease Activity. The range of DAS28 score is 0-10. Higher score means more active disease. Negative change from baseline indicates a favorable outcome. | Full Analysis Set (FAS): All participants from the randomized set to whom study treatment had been assigned. This is subset of participants from the randomized set to whom study treatment had been assigned and had a valid value of the outcome measure. | Posted | Least Squares Mean | Standard Error | scores on a scale | 16 weeks |
|
|
|
|
| Secondary | Change From Baseline in PASDAS Scores Using MMRM at Week 16 | To assess the the effect of secukinumab versus placebo on change from Baseline in PASDAS. Assessment was based on reduction in PASDAS score. PASDAS is a measure of disease activity based on Patient reported measures (excluding mental component score (MCS) of the medical outcomes survey Short Form-36 (SF-36-PCS)), skin, peripheral joint counts (Tender and Swollen joint counts), Dactylitis (LDI), Enthesitis (LEI), acute phase response (CRP) and Patient & Physician global VAS scores. The range of PASDAS is 0-10. Higher score means more active disease. Negative change from baseline indicates a favorable outcome. | Full Analysis Set (FAS): All participants from the randomized set to whom study treatment had been assigned. This is subset of participants from the randomized set to whom study treatment had been assigned and had a valid value of the outcome measure. | Posted | Least Squares Mean | Standard Error | scores on a scale | 16 weeks |
|
|
|
|
| Secondary | Change From Baseline in SF36-PCS Scores Using MMRM at Week 16 | To assess the effect of secukinumab versus placebo on change from Baseline in SF-36 PCS. The SF-36 is a widely used and extensively studied instrument to measure HRQoL among healthy participants and participants with acute and chronic conditions. Two overall summary scores, the Physical Component Score (PCS) and the Mental Component Score (MCS) also can be computed. SF36-PCS was used in this study. The range of SF36-PCS score is 0-100. Higher score means better health status. Negative change from baseline indicates a unfavorable outcome. | Full Analysis Set (FAS): All participants from the randomized set to whom study treatment had been assigned. This is subset of participants from the randomized set to whom study treatment had been assigned and had a valid value of the outcome measure. | Posted | Least Squares Mean | Standard Error | scores on a scale | 16 weeks |
|
|
|
|
| Secondary | Change From Baseline in HAQ-DI Scores Using MMRM at Week 16 | To assess the effect of secukinumab versus placebo on change from Baseline in HAQ-DI. Assessment was based on improvement in HAQ-DI PCS scores. The HAQ-DI© is one of the most widely used measures to assess the long-term influence of chronic disease on a participant's level of functional ability and activity restriction, and calculated based on HAQ-DI questionnaire. There are 20 questions in eight categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The range of score is 0-3. Higher score means more severe disability. Negative change from baseline indicates a favorable outcome. | Full Analysis Set (FAS): All participants from the randomized set to whom study treatment had been assigned. This is subset of participants from the randomized set to whom study treatment had been assigned and had a valid value of the outcome measure. | Posted | Least Squares Mean | Standard Error | scores on a scale | 16 weeks |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 27 |
| 30 |
| EG001 | Any AIN457 300 mg | Participants who received Secukinumab 300 mg dose (dose level 2) at any point during the trial. | 0 | 21 | 1 | 21 | 16 | 21 |
| EG002 | Any AIN457 | Participants who received Secukinumab, regardless of dose, at any point during the trial. | 0 | 41 | 1 | 41 | 37 | 41 |
| EG003 | Placebo | Participants who received Placebo at any point during the trial. | 0 | 21 | 0 | 21 | 16 | 21 |
| Epiretinal membrane | Eye disorders | MedDRA (25.1) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA (25.1) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (25.1) | Systematic Assessment |
|
| Thyroid mass | Endocrine disorders | MedDRA (25.1) | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA (25.1) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (25.1) | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA (25.1) | Systematic Assessment |
|
| Retinoschisis | Eye disorders | MedDRA (25.1) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Helicobacter infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Suspected COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
|
| Chillblains | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Electrocardiogram high voltage | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Total bile acids increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Urinary occult blood positive | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
|
| Impaired fasting glucose | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
|
| Allergic pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (25.1) | 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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| D009140 |
| Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |