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This study is designed as a proof of concept of AIN457 in patients with psoriatic arthritis. The study will address the evaluation of the efficacy at 6 and up to 24 weeks after two doses of AIN457 10 mg/kg administered three weeks apart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIN457 (2x 10mg/kg) | Experimental | Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22. |
|
| Placebo | Placebo Comparator | Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIN457 | Biological | The investigational drug, AIN457 50 mg lyophilizate vials was prepared by Novartis. Reconstitution of AIN457 with 1.2 mL SWFI produced a 47 mg/mL concentrate solution for infusion from which at least 1 mL was useable. The AIN457 concentrate was diluted in 5% glucose bags for infusion through a 0.2 micron in-line filter. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of ACR Responders Per Treatment at Week 6 | A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP) | week 6 |
| Percentage of PsARC Responders Per Treatment at Week 6 | Psoriatic Arthritis Response Criteria (PsARC) includes measures of tender and swollen joint counts, patient's assessment of pain, physician's and patient's global assessment of disease activity A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%) | week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved 20%, 50% or 70% Improvement as Measured by ACR Response Criteria | A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis | Novartis Investigator Site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Berlin | 12203 | Germany | |||
| Novartis Investigative Site |
Not provided
A total of 42 patients were planned and recruited. The patients were randomized to either AIN457 2x10 mg/kg or placebo in a ratio of 2:1. The total sample size of 42 included an additional 3 subjects to allow for drop-outs and/or incomplete data.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AIN457 (2x 10mg/kg) | Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22. |
| FG001 | Placebo | Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients who received at least one dose of study drug were included in the safety and tolerability evaluation.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AIN457 (2x 10mg/kg) | Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22. |
| BG001 | Placebo | Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22. |
| 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 | Percentage of ACR Responders Per Treatment at Week 6 | A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP) | For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations. | Posted | Number | Percentage of ACR responders | week 6 |
|
Not provided
The Safety Set includes all subjects who received at least one dose of study medication
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AIN457 2x10mg/kg | Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 862-778-8300 |
Not provided
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Biological | Matching placebo to AIN457 |
|
| Day 8 and 15, Weeks 6, 8, 12, 16 and 24 |
| Percentage of Participants Who Achieved PsARC Response | responder" defined as 20% or more improvement in at least 4 of 6 criteria: 1) swollen joint count, 2) tender joint count, 3) morning stiffness duration (low back), 4) current low back pain, 5) current peripheral joint pain, 6) patient global assessment A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%) | Day 8 and 15, Weeks 6, 8, 12, 16 and 24 |
| Mastricht Ankylosing Spondylitis Enthesis Score (MASES) Over Time Per Treatment | The MASES included assessments of 13 sites. Enthesitis sites included in the MASES index are: 1st costochondral, 7th costochondral, posterior superior iliac spine, anterior superior iliac spine, iliac crest (all above was assessed bilaterally), 5th lumbar spinous process, proximal Achilles (bilateral). The MASES score is defined as the total number of painful MASES entheses. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness). | Baseline and Day 8, 15 and weeks 6, 8, 12, 16 and 24 |
| Psoriatic Area and Severity Index (PASI) Score in Patients Over Time Per Treatment | The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper and lower limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness, and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease). | Baseline, Day 8, 15 and weeks 6, 8, 12, 16, 20 and 24 |
| SpA Research Consortium of Canada (SPARCC) Score Score in Patients Over Time Per Treatment | SPARCC evaluated 18 enthesis sites: medial and lateral epicondyle humerus, supraspinatus insertion, proximal Achilles, greater trochanter, medial and lateral condyl femur, insertion of plantar fascia, quadriceps insertion of patella, inferior pole of patella, and tibial tubercle. SPARCC enthesis index is defined as the total number of painful entheses assessed at the SPARCC sites. Total SI joint scores could range from 0 to 78, with a higher score indicating more signs of disease. | Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24 |
| Leeds Dactylitis Instrument (LDI) Score in Patients Over Time Per Treatment | The LDI basic measured the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference was multiplied by a tenderness score, using a modification of LDI which was a binary score (1 for tender, 0 for non-tender). If both sides were considered involved, the number was compared to data provided in a table. This modification was referred to as LDI basic and was applied in this study. The LDI required a tool to measure digital circumference and this tool was provided to the centers. | Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24 |
| Disease Activity Score 28 (DA28) in Patients Over Time Per Treatment | The Disease Activity Score (DAS) is a combined index to measure disease activity in arthritic patients. DAS28 is determined using the following variables: 28-joint counts (tender28 and swollen28), CRP, and the participant's general health (GH) Based on the patients global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 - 100). Using the data from these variables, DAS28 is calculated using the following formula: DAS28 = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. The calculation results in a DAS28 score from 0 to 10 indicating the current activity of the rheumatoid arthritis of the patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. | Baseline, day 8, 15 and weeks 6, 8, 12, 16 and 24 |
| Pharmacokinetic (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) | On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169. | Day 1 till end of the study (169) |
| Pharmacokinetic (PK) of AIN457: Clearance of AIN457 After Single Dose Administration | On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169. | Day 1 till end of the study (169) |
| Pharmacokinetic (PK) of AIN457: Terminal Elimination Half-life (T1/2) | On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169. | Day 1 till end of the study (169) |
| Pharmacokinetic (PK) of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) | On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169. | Day 1 till end of the study (169) |
| PK of AIN457: Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) | On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169. | Day 1 till end of the study (169) |
| Pharmacokinetic (PK) of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) | On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169. | Day 1 till end of the study (169) |
| Hamburg |
| 22081 |
| Germany |
| Novartis Investigative Site | Hamburg | 22415 | Germany |
| Novartis Investigative Site | Herne | 44649 | Germany |
| Novartis Investigative Site | München | 80336 | Germany |
| Novartis Investigative Site | Amsterdamn | 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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Placebo |
Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22. |
|
|
| Primary | Percentage of PsARC Responders Per Treatment at Week 6 | Psoriatic Arthritis Response Criteria (PsARC) includes measures of tender and swollen joint counts, patient's assessment of pain, physician's and patient's global assessment of disease activity A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%) | For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations. | Posted | Number | Percentage of PsARC responders | week 6 |
|
|
|
| Secondary | Percentage of Participants Who Achieved 20%, 50% or 70% Improvement as Measured by ACR Response Criteria | A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP) | For pharmacodynamic (PD) analysis set five patients were excluded due to protocoldeviations. | Posted | Number | Percentage of particpants | Day 8 and 15, Weeks 6, 8, 12, 16 and 24 |
|
|
|
| Secondary | Percentage of Participants Who Achieved PsARC Response | responder" defined as 20% or more improvement in at least 4 of 6 criteria: 1) swollen joint count, 2) tender joint count, 3) morning stiffness duration (low back), 4) current low back pain, 5) current peripheral joint pain, 6) patient global assessment A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%) | For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations. | Posted | Number | Percentage of participants | Day 8 and 15, Weeks 6, 8, 12, 16 and 24 |
|
|
|
| Secondary | Mastricht Ankylosing Spondylitis Enthesis Score (MASES) Over Time Per Treatment | The MASES included assessments of 13 sites. Enthesitis sites included in the MASES index are: 1st costochondral, 7th costochondral, posterior superior iliac spine, anterior superior iliac spine, iliac crest (all above was assessed bilaterally), 5th lumbar spinous process, proximal Achilles (bilateral). The MASES score is defined as the total number of painful MASES entheses. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness). | For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Day 8, 15 and weeks 6, 8, 12, 16 and 24 |
|
|
|
| Secondary | Psoriatic Area and Severity Index (PASI) Score in Patients Over Time Per Treatment | The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper and lower limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness, and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease). | For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations | Posted | Mean | Standard Deviation | Unit on a Scale | Baseline, Day 8, 15 and weeks 6, 8, 12, 16, 20 and 24 |
|
|
|
| Secondary | SpA Research Consortium of Canada (SPARCC) Score Score in Patients Over Time Per Treatment | SPARCC evaluated 18 enthesis sites: medial and lateral epicondyle humerus, supraspinatus insertion, proximal Achilles, greater trochanter, medial and lateral condyl femur, insertion of plantar fascia, quadriceps insertion of patella, inferior pole of patella, and tibial tubercle. SPARCC enthesis index is defined as the total number of painful entheses assessed at the SPARCC sites. Total SI joint scores could range from 0 to 78, with a higher score indicating more signs of disease. | For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24 |
|
|
|
| Secondary | Leeds Dactylitis Instrument (LDI) Score in Patients Over Time Per Treatment | The LDI basic measured the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference was multiplied by a tenderness score, using a modification of LDI which was a binary score (1 for tender, 0 for non-tender). If both sides were considered involved, the number was compared to data provided in a table. This modification was referred to as LDI basic and was applied in this study. The LDI required a tool to measure digital circumference and this tool was provided to the centers. | Only participants from the pharmacodynamic (PD) analysis set, who had available scores at each given time point, were analyzed for that time point. The PD analysis set included all patients with evaluable PD data with no protocol deviations that impacted PD data analysis. | Posted | Mean | Standard Deviation | total score | Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24 |
|
|
|
| Secondary | Disease Activity Score 28 (DA28) in Patients Over Time Per Treatment | The Disease Activity Score (DAS) is a combined index to measure disease activity in arthritic patients. DAS28 is determined using the following variables: 28-joint counts (tender28 and swollen28), CRP, and the participant's general health (GH) Based on the patients global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 - 100). Using the data from these variables, DAS28 is calculated using the following formula: DAS28 = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. The calculation results in a DAS28 score from 0 to 10 indicating the current activity of the rheumatoid arthritis of the patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. | For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations | Posted | Mean | Standard Deviation | Units on a scale | Baseline, day 8, 15 and weeks 6, 8, 12, 16 and 24 |
|
|
|
| Secondary | Pharmacokinetic (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) | On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169. | Only patients who recieved active drug with evaluable pharmacokinetic ( PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set | Posted | Median | Full Range | Day | Day 1 till end of the study (169) |
|
|
|
| Secondary | Pharmacokinetic (PK) of AIN457: Clearance of AIN457 After Single Dose Administration | On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169. | Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set | Posted | Mean | Standard Deviation | Liters/day | Day 1 till end of the study (169) |
|
|
|
| Secondary | Pharmacokinetic (PK) of AIN457: Terminal Elimination Half-life (T1/2) | On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169. | Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set | Posted | Mean | Standard Deviation | day | Day 1 till end of the study (169) |
|
|
|
| Secondary | Pharmacokinetic (PK) of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) | On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169. | Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set | Posted | Mean | Standard Deviation | ug/mL | Day 1 till end of the study (169) |
|
|
|
| Secondary | PK of AIN457: Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) | On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169. | Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set | Posted | Mean | Standard Deviation | day*ug/mL | Day 1 till end of the study (169) |
|
|
|
| Secondary | Pharmacokinetic (PK) of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) | On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169. | Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set | Posted | Mean | Standard Deviation | Liters | Day 1 till end of the study (169) |
|
|
|
| 4 |
| 28 |
| 23 |
| 28 |
| EG001 | Placebo | Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22. | 1 | 14 | 11 | 14 |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | 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 or disclosure of trial results in their entirety
| 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 |
| Day 8 ACR70 responders |
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| Day 15 ACR20 responders |
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| Day 15 ACR50 responders |
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| Day 15 ACR70 responders |
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| Week 6 ACR20 responders |
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| Week 6 ACR50 responders |
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| Week 6 ACR70 responders |
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| Week 8 ACR20 responders |
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| Week 8 ACR50 responders |
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| Week 8 ACR70 responders |
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| Week 12 ACR20 responders |
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| Week 12 ACR50 responders |
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| Week 12 ACR70 responders |
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| Week 16 ACR20 responders |
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| Week 16 ACR50 responders |
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| Week 16 ACR70 responders |
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| Week 24 ACR20 responders |
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| Week 24 ACR50 responders |
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| Week 24 ACR70 responders |
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| Week 6 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 24 |
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| Day 15 (24,13) |
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| Week 6 (n=23,11) |
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| Week 8 (n=22,11) |
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| Week 12 (n=20,11) |
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| Week 16 (n=19,9) |
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| Week 24 (n=23,11) |
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| Week 12 (n=20,11) |
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| Week 24 (n=23,11) |
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| Day 8 (n=23,13) |
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| Day 15 (n=24,13) |
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| Week 8 (n=22,11) |
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| Week 16 (n=19,9) |
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| Week 20 (n=19,8) |
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| Week 12 (n=20,11) |
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| Week 24 (n=23,11) |
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| Day 8 (23,13) |
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| Day 15 (n=24,13) |
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| Week 8 (n=22,11) |
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| Week 16 (n=19,9) |
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| Week 12 (n=3,6) |
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| Week 24 (n=2,6) |
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| Day 8 (n=5,5) |
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| Day 15 (n=4,5) |
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| Week 8 (n=3,5) |
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| Week 16 (n=3,4) |
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| Week 12 (n=23,11) |
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| Week 24 (n=23,11) |
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| Day 8 (22,12) |
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| Day 15 (24,13) |
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| Week 8 (n=22,10) |
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| Week 16 (n=18,9) |
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