| Primary | Percentage of Participants Who Achieved ASAS20 Response | Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of 20% or more and absolute improvement of at least 1 units (on a scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (worsening of at least 20% an absolute Worsening of at least 1 unit) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores | Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation | Posted | | Number | | Percentage | | 6 Weeks | | | | ID | Title | Description |
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| OG000 | Part 1 - AIN457A 10 mg/kg | AIN457A 10.0 mg/kg was administered intravenously as a single dose. | | OG001 | Part 1 - Placebo | Placebo to AIN457A was administered intravenously as a single dose |
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| Primary | Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to 6 Weeks After First Infusion in Part 2 | ASAS20 as described in Primary Outcome. ASAS40 responder had improvement of 40% or more and absolute improvement of at least 2 units (on a scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with no deterioration in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); Spinal Mobility (BASFI); Acute phase reactant (CRP) | Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements | Posted | | Least Squares Mean | 95% Confidence Interval | Units on a scale | | 6 Weeks | | | | ID | Title | Description |
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| OG000 | Parts 1 and 2 - AIN457A 10 mg/kg | AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. |
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| Secondary | Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1 | ASAS20 responder had improvement of 40% or more and absolute improvement of at least 2 units (scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with no deterioration in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); Spinal Mobility (BASFI); Acute phase reactant (CRP) | Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation | Posted | | Number | | Participants | | Day8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28 | | | | ID | Title | Description |
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| OG000 | Part 1 - AIN457A 10 mg/kg | AIN457A 10.0 mg/kg was administered intravenously as a single dose. | | OG001 | Part 1 - Placebo |
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| Secondary | Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined | a Bayesian model was fitted to the ASAS20 , ASAS40 and ASAS 5/6 response rates on active and placebo treatments. A Bayesian analysis had been chosen to allow the direct incorporation into the analysis of information about placebo response rates from historical data | Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements | Posted | | Number | | Participants | | Day 8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28 | | | | ID | Title | Description |
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| OG000 | Parts 1 and 2 - AIN457A 10 mg/kg | AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | | OG001 | Part 1 and 2 - AIN457 1.0 mg/kg | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 | | OG002 | Part 1 and 2 - AIN457 0.1 mg/kg | AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 |
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| Secondary | Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1 | The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of ASspiMRI-a (ASspiMRI-a) scoring technique assesses inflammation in each of the 23 disc vertebral units (DVU), capturing edema and erosion. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema (less than25% of DVU; 3=severe bone marrow edema (more that 50% of DVU). The composite score ranges from 0 to 69, with higher scores indicating more severe inflammation | Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation | Posted | | Mean | Standard Deviation | Score | | Baseline, week 6, week 28 | | | | ID | Title | Description |
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| OG000 | Part 1 - AIN457A 10 mg/kg | AIN457A 10.0 mg/kg was administered intravenously as a single dose. | | OG001 | Part 1 - Placebo | Placebo to AIN457A was administered intravenously as a single dose |
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| Secondary | Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 | Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28. | Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded. | Posted | | Median | Full Range | Days | | Week 28 | | | | ID | Title | Description |
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| OG000 | Part 1 - AIN457A 10 mg/kg | AIN457A 10.0 mg/kg was administered intravenously as a single dose. |
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| Secondary | Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 and 2 | Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28. | Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded. | Posted | | Median | Full Range | Days | | Week 28 | | | | ID | Title | Description |
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| OG000 | Parts 1 and 2 - AIN457A 10 mg/kg | AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | | OG001 | Part 1 and 2 - AIN457 1.0 mg/kg | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 | | OG002 | Part 1 and 2 - AIN457 0.1 mg/kg | AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 |
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| Secondary | PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 | Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28 | Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded | Posted | | Mean | Standard Deviation | ug/mL | | Week 28 | | | | ID | Title | Description |
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| OG000 | Part 1 - AIN457A 10 mg/kg | AIN457A 10.0 mg/kg was administered intravenously as a single dose. |
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| Secondary | PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 and 2 | Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28 | Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded | Posted | | Mean | Standard Deviation | ug/mL | | Week 28 | | | | ID | Title | Description |
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| OG000 | Parts 1 and 2 - AIN457A 10 mg/kg | AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | | OG001 | Part 1 and 2 - AIN457 1.0 mg/kg | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 | | OG002 | Part 1 and 2 - AIN457 0.1 mg/kg | AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 |
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| Secondary | PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1 | Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28 | Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded | Posted | | Mean | Standard Deviation | day*ug/mL | | Week 28 | | | | ID | Title | Description |
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| OG000 | Part 1 - AIN457A 10 mg/kg | AIN457A 10.0 mg/kg was administered intravenously as a single dose. |
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| Secondary | PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1 and 2 | Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28 | Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded | Posted | | Mean | Standard Deviation | day*ug/mL | | Week 28 | | | | ID | Title | Description |
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| OG000 | Parts 1 and 2 - AIN457A 10 mg/kg | AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | | OG001 | Part 1 and 2 - AIN457 1.0 mg/kg | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 | | OG002 | Part 1 and 2 - AIN457 0.1 mg/kg | |
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| Secondary | PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 | Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28 | Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded | Posted | | Mean | Standard Deviation | Liters/day | | Week 28 | | | | ID | Title | Description |
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| OG000 | Part 1 - AIN457A 10 mg/kg | AIN457A 10.0 mg/kg was administered intravenously as a single dose. |
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| Secondary | PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 and 2 | Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28 | Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded | Posted | | Mean | Standard Deviation | Liters/day | | Week 28 | | | | ID | Title | Description |
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| OG000 | Parts 1 and 2 - AIN457A 10 mg/kg | AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | | OG001 | Part 1 and 2 - AIN457 1.0 mg/kg | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 | | OG002 | Part 1 and 2 - AIN457 0.1 mg/kg | AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 |
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| Secondary | PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 | Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28 | Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded | Posted | | Mean | Standard Deviation | Liters | | Week 28 | | | | ID | Title | Description |
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| OG000 | Part 1 - AIN457A 10 mg/kg | AIN457A 10.0 mg/kg was administered intravenously as a single dose. |
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| Secondary | PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 and 2 | Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28 | Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded | Posted | | Mean | Standard Deviation | Liters | | Week 28 | | | | ID | Title | Description |
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| OG000 | Parts 1 and 2 - AIN457A 10 mg/kg | AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | | OG001 | Part 1 and 2 - AIN457 1.0 mg/kg | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 | | OG002 | Part 1 and 2 - AIN457 0.1 mg/kg | AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 |
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| Secondary | PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 | Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28 | Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded | Posted | | Mean | Standard Deviation | day | | Week 28 | | | | ID | Title | Description |
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| OG000 | Part 1 - AIN457A 10 mg/kg | AIN457A 10.0 mg/kg was administered intravenously as a single dose. |
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| Secondary | PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 and 2 | Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28 | Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded | Posted | | Mean | Standard Deviation | day | | Week 28 | | | | ID | Title | Description |
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| OG000 | Parts 1 and 2 - AIN457A 10 mg/kg | AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | | OG001 | Part 1 and 2 - AIN457 1.0 mg/kg | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 | | OG002 | Part 1 and 2 - AIN457 0.1 mg/kg | AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 |
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| Secondary | Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2 | BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement | Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements | Posted | | Mean | Standard Deviation | Score | | Baseline, day 8,15,29, week 6,8,10,12,16,20,24,28 | | | | ID | Title | Description |
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| OG000 | Parts 1 and 2 - AIN457A 10 mg/kg | AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 | | OG001 | Part 1 and 2 - AIN457 1.0 mg/kg | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 | |
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| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2 | The BASDAI consists of a 1 through 10 scale (1 being no problem and 10 being the worst problem), which was used to answer 6 questions pertaining to the 5 major symptoms of AS: Fatigue, Spinal pain, Joint pain / swelling, areas of localized tenderness (called enthesitis, or inflammation of insertion sites of tendons and ligaments), morning stiffness duration, and morning stiffness severity. The physician will globally assess the subject's current disease state using a visual analog scale (VAS) scale with 0 being very good and 100 being very bad. | Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements | Posted | | Least Squares Mean | 95% Confidence Interval | Score | | Baseline, day 8,15,29,week 6,8,10,12,16,20,24,28 | | | | ID | Title | Description |
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| OG000 | Parts 1 and 2 - AIN457A 10 mg/kg | AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | | OG001 | Part 1 and 2 - AIN457 1.0 mg/Kg | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 |
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| Secondary | Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 | MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. 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). | Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation | Posted | | Mean | Standard Deviation | Score | | Baseline, day 8,15,29,week, 6, 8,10,12,16,20,24,28 | | | | ID | Title | Description |
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| OG000 | Part 1 - AIN457A 10 mg/kg | AIN457A 10.0 mg/kg was administered intravenously as a single dose. | | OG001 | Part 1 - Placebo | Placebo to AIN457A was administered intravenously as a single dose |
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| Secondary | Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2 | MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. 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). | Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements | Posted | | Mean | Standard Deviation | Score | | Day 8,15,29,week, 6, 10,12,16,20,24,28 | | | | ID | Title | Description |
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| OG000 | Parts 1 and 2 - AIN457A 10 mg/kg | AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | | OG001 | Part 1 and 2 - AIN457 1.0 mg/kg | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 | | OG002 | Part 1 and 2 - AIN457 0.1 mg/kg | AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22 |
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| Secondary | Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1. | The Short Form (36) Health Survey (SF-36) measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with higher scores indicative of better health. ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of "1" or "0." All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement. | Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements | Posted | | Mean | Standard Deviation | Score | | SF-36:Baseline, week 12, week 28; ASQoL: Baseline, Day 29, week 12, week 28 | | | | ID | Title | Description |
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| OG000 | Part 1 - AIN457A 10 mg/kg | AIN457A 10.0 mg/kg was administered intravenously as a single dose. |
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| Secondary | Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2. | The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of "1" or "0." All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement. | Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements | Posted | | Mean | Standard Deviation | Score | | SF-36: Baseline, week 12, week 28; ASQoL: Baseline, day 29, week 12, week 8 | | | | ID | Title | Description |
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| OG000 | Parts 1 and 2 - AIN457A 10 mg/kg | AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | |
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