ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 387 for:    Ankylosing Spondylitis

Double Blind, Placebo Controlled Study to Assess Efficacy of AIN457 in Moderate to Severe Ankylosing Spondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00809159
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : September 18, 2015
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator)
Condition Ankylosing Spondylitis
Interventions Biological: AIN457
Drug: Placebo
Enrollment 60

Recruitment Details Part 1 of the study, patients received 2 infusions spaced three weeks apart of 10 mg/kg AIN457 or placebo, and in Part 2 of the study, patients received 2 infusions spaced three weeks apart of 0.1 mg/kg, 1.0 mg/kg or 10 mg/kg AIN457, respectively.
Pre-assignment Details Part 1 participants were randomized 4:1 to receive AIN457A or placebo. Part 2, the randomization ratio was to be 2:2:1 for the three dose groups, 0.1 mg/kg, 1 mg/kg and 10 mg/kg. More subjects were randomized to the 0.1 and 1mg/kg dose groups as compared to the 10 mg/kg group, as 24 subjects were already randomized to the 10 mg/kg group in Part 1.
Arm/Group Title Part 1 - AIN457A 10 mg/kg Part 1 - Placebo Parts 1 and 2 - AIN457A 10 mg/kg Part 1 and 2 - AIN457 1.0 mg/kg Part 1 and 2 - AIN457 0.1 mg/kg Part 1 and 2 - Placebo
Hide Arm/Group Description AIN457A 10.0 mg/kg was administered intravenously as a single dose. Placebo to AIN457A was administered intravenously as a single dose 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. 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 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 Placebo to AIN457A was administered intravenously as a single dose
Period Title: Part 1
Started 24 6 0 0 0 0
PK Analysis Set 24 6 0 0 0 0
PD Analysis Set 23 6 0 0 0 0
Completed 16 3 0 0 0 0
Not Completed 8 3 0 0 0 0
Reason Not Completed
Adverse Event             1             1             0             0             0             0
Lost to Follow-up             1             0             0             0             0             0
Withdrawal by Subject             3             1             0             0             0             0
Unsatisfactory therapeutic effect             3             1             0             0             0             0
Period Title: Part 1 and 2
Started 0 0 30 12 12 6
PK Analysis Set 0 0 30 12 12 6
PD Analysis Set 0 0 28 12 12 6
Completed 0 0 20 7 6 3
Not Completed 0 0 10 5 6 3
Reason Not Completed
Unsatisfactory therapeutic effect             0             0             4             3             5             1
Administrative problems             0             0             0             1             0             0
Adverse Event             0             0             1             0             1             1
Lost to Follow-up             0             0             1             1             0             0
Withdrawal by Subject             0             0             4             0             0             1
Arm/Group Title Parts 1 and 2 - AIN457A 10 mg/kg Part 1 and 2 - AIN457 1.0 mg/kg Part 1 and 2 - AIN457 0.1 mg/kg Part 1 and 2 - Placebo Total
Hide Arm/Group Description 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. 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 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 Placebo to AIN457A was administered intravenously as a single dose Total of all reporting groups
Overall Number of Baseline Participants 30 12 12 6 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 12 participants 12 participants 6 participants 60 participants
40.7  (9.69) 47.2  (10.50) 42.8  (9.17) 45.0  (9.96) 42.8  (9.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 12 participants 12 participants 6 participants 60 participants
Female
11
  36.7%
6
  50.0%
4
  33.3%
1
  16.7%
22
  36.7%
Male
19
  63.3%
6
  50.0%
8
  66.7%
5
  83.3%
38
  63.3%
1.Primary Outcome
Title Percentage of Participants Who Achieved ASAS20 Response
Hide Description 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
Time Frame 6 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Part 1 - AIN457A 10 mg/kg Part 1 - Placebo
Hide Arm/Group Description:
AIN457A 10.0 mg/kg was administered intravenously as a single dose.
Placebo to AIN457A was administered intravenously as a single dose
Overall Number of Participants Analyzed 23 6
Measure Type: Number
Unit of Measure: Percentage
59.2 24.5
2.Primary Outcome
Title Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to 6 Weeks After First Infusion in Part 2
Hide Description 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)
Time Frame 6 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Parts 1 and 2 - AIN457A 10 mg/kg Part 1 and 2 - AIN457 1.0 mg/kg Part 1 and 2 - AIN457 0.1 mg/kg Part 1 and 2 - Placebo
Hide Arm/Group Description:
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.
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
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
Placebo to AIN457A was administered intravenously as a single dose
Overall Number of Participants Analyzed 26 11 11 3
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-1.87
(-2.691 to -1.051)
-2.0151
(-3.275 to -0.755)
-1.2002
(-2.514 to 0.113)
-1.0577
(-2.893 to 0.777)
3.Secondary Outcome
Title Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1
Hide Description 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)
Time Frame Day8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Part 1 - AIN457A 10 mg/kg Part 1 - Placebo
Hide Arm/Group Description:
AIN457A 10.0 mg/kg was administered intravenously as a single dose.
Placebo to AIN457A was administered intravenously as a single dose
Overall Number of Participants Analyzed 23 6
Measure Type: Number
Unit of Measure: Participants
ASAS20 at Day 8 9 2
ASAS20 at Day 15 9 1
ASAS20 at Day 29 11 0
ASAS40 at Day 8 4 0
ASAS40 at Day 15 4 0
ASAS40 at Day 29 8 0
ASAS 5/6 at Day 8 5 1
ASAS 5/6 at Day 15 5 0
ASAS 5/6 at Day 29 8 0
ASAS20 at week 6 14 1
ASAS20 at week 8 8 1
ASAS20 at week 10 9 0
ASAS20 at week 12 9 1
ASAS20 at week 16 8 1
ASAS20 at week 20 6 1
ASAS20 at week 24 7 0
ASAS20 at week 28 7 1
ASAS40 at week 6 7 1
ASAS40 at week 8 5 0
ASAS40 at week 10 5 0
ASAS40 at week 12 3 0
ASAS40 at week 16 3 1
ASAS40 at week 20 2 1
ASAS40 at week 24 3 0
ASAS40 at week 28 2 0
ASAS 5/6 at week 6 8 0
ASAS 5/6 at week 8 7 0
ASAS 5/6 at week 10 6 0
ASAS 5/6 at week 12 3 0
ASAS 5/6 at week 16 4 0
ASAS 5/6 at week 20 2 1
ASAS 5/6 at week 24 3 0
ASAS 5/6 at week 28 1 0
4.Secondary Outcome
Title Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined
Hide Description 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
Time Frame Day 8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Parts 1 and 2 - AIN457A 10 mg/kg Part 1 and 2 - AIN457 1.0 mg/kg Part 1 and 2 - AIN457 0.1 mg/kg Part 1 and 2 - Placebo
Hide Arm/Group Description:
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.
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
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
Placebo to AIN457A was administered intravenously as a single dose
Overall Number of Participants Analyzed 28 12 12 6
Measure Type: Number
Unit of Measure: Participants
ASAS20 at day 8 (n=28,12,12,6) 12 3 6 2
ASAS20 at day 15 (n=28,12,12,5) 11 7 4 1
ASAS20 at day 29 (n=28,12,11,6) 14 6 4 0
ASAS40 at day 8 (n=28,12,12,6) 6 2 2 0
ASAS40 at day 15 (n=28,12,12,5) 5 3 3 0
ASAS40 at day 29 (28,12,11,6) 10 3 1 0
ASAS 5/6 at day 8 (28,12,12,6) 6 3 5 1
ASAS 5/6 at day 15 (n=28,12,12,5) 5 5 2 0
ASAS 5/6 at day 29 (n=28,12,11,6) 9 5 3 0
ASAS20 at week 6 (n=27,11,11,6) 16 4 3 1
ASAS20 at week 8 (n=28,11,11,6) 10 4 3 1
ASAS20 at week 10 (n=27,11,10,6) 11 5 2 0
ASAS20 at week 12 (n=27,12,11,6) 12 3 4 1
ASAS20 at week 16 (n=28,12,11,6) 9 5 3 1
ASAS20 at week 20 (n=28,12,11,6) 6 4 2 1
ASAS20 at week 24 (n=28,12,11,6) 7 2 1 0
ASAS20 at week 28 (n=28,11,11,6) 8 2 2 1
ASAS40 at week 6 (n=27,11,11,6) 8 2 3 1
ASAS40 at week 8 (n=28,11,11,6) 5 2 2 0
ASAS40 at week 10 (28,11,11,6) 5 2 1 0
ASAS40 at week 12 (n=27,12,11,6) 3 2 3 0
ASAS40 at week 16 (n=28,12,11,6) 3 3 2 1
ASAS40 at week 20 (n=28,12,11,6) 2 1 2 1
ASAS40 at week 24 (n=28,12,11,6) 3 1 1 0
ASAS40 at week 28 (n=28,11,11,6) 3 0 1 0
ASAS 5/6 at week 6 (n=28,11,11,6) 9 3 2 0
ASAS 5/6 at week 8 (n=28,11,11,6) 7 4 1 0
ASAS 5/6 at week 10 (n=27,11,10,6) 6 4 1 0
ASAS 5/6 at week 12 (n=28,12,11,6) 5 2 1 0
ASAS 5/6 at week 16 (n=28,12,11,6) 5 5 2 0
ASAS 5/6 at week 20 (n=28,12,11,6) 2 3 1 1
ASAS 5/6 at week 24 (n=28,12,11,6) 3 2 1 0
ASAS 5/6 at week 28 (n=28,11,10,6) 2 0 1 0
5.Secondary Outcome
Title Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1
Hide Description 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
Time Frame Baseline, week 6, week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Part 1 - AIN457A 10 mg/kg Part 1 - Placebo
Hide Arm/Group Description:
AIN457A 10.0 mg/kg was administered intravenously as a single dose.
Placebo to AIN457A was administered intravenously as a single dose
Overall Number of Participants Analyzed 22 5
Mean (Standard Deviation)
Unit of Measure: Score
Baseline (n=22,5) 9.2  (8.87) 20.6  (20.18)
Week 6 (n=22,3) 6.6  (6.56) 21.0  (24.56)
Week 28 (n=16,5) 5.7  (6.20) 19.0  (19.33)
6.Secondary Outcome
Title Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1
Hide Description 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.
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part 1 - AIN457A 10 mg/kg
Hide Arm/Group Description:
AIN457A 10.0 mg/kg was administered intravenously as a single dose.
Overall Number of Participants Analyzed 23
Median (Full Range)
Unit of Measure: Days
21.07
(0.083 to 21.9)
7.Secondary Outcome
Title Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 and 2
Hide Description 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.
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Parts 1 and 2 - AIN457A 10 mg/kg Part 1 and 2 - AIN457 1.0 mg/kg Part 1 and 2 - AIN457 0.1 mg/kg
Hide Arm/Group Description:
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.
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
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
Overall Number of Participants Analyzed 28 12 12
Median (Full Range)
Unit of Measure: Days
21.08
(0.083 to 22.2)
21.08
(0.125 to 23.0)
21.12
(19.1 to 22.1)
8.Secondary Outcome
Title PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1
Hide Description 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
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Part 1 - AIN457A 10 mg/kg
Hide Arm/Group Description:
AIN457A 10.0 mg/kg was administered intravenously as a single dose.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: ug/mL
357.7  (87.74)
9.Secondary Outcome
Title PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 and 2
Hide Description 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
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Parts 1 and 2 - AIN457A 10 mg/kg Part 1 and 2 - AIN457 1.0 mg/kg Part 1 and 2 - AIN457 0.1 mg/kg
Hide Arm/Group Description:
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.
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
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
Overall Number of Participants Analyzed 28 12 12
Mean (Standard Deviation)
Unit of Measure: ug/mL
363.9  (82.30) 33.13  (9.828) 5.509  (5.418)
10.Secondary Outcome
Title 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
Hide Description 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
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Part 1 - AIN457A 10 mg/kg
Hide Arm/Group Description:
AIN457A 10.0 mg/kg was administered intravenously as a single dose.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: day*ug/mL
AUCinf 10510  (3036)
AUClast 10310  (2869)
11.Secondary Outcome
Title 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
Hide Description 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
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Parts 1 and 2 - AIN457A 10 mg/kg Part 1 and 2 - AIN457 1.0 mg/kg Part 1 and 2 - AIN457 0.1 mg/kg
Hide Arm/Group Description:
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.
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
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
Overall Number of Participants Analyzed 25 11 11
Mean (Standard Deviation)
Unit of Measure: day*ug/mL
AUCinf 10880  (2983) 1025  (276.0) 198.0  (195.5)
AUClast 10630  (2818) 993.0  (279.5) 187.7  (190.7)
12.Secondary Outcome
Title PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1
Hide Description 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
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Part 1 - AIN457A 10 mg/kg
Hide Arm/Group Description:
AIN457A 10.0 mg/kg was administered intravenously as a single dose.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: Liters/day
0.1594  (0.04998)
13.Secondary Outcome
Title PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 and 2
Hide Description 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
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Parts 1 and 2 - AIN457A 10 mg/kg Part 1 and 2 - AIN457 1.0 mg/kg Part 1 and 2 - AIN457 0.1 mg/kg
Hide Arm/Group Description:
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.
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
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
Overall Number of Participants Analyzed 25 11 11
Mean (Standard Deviation)
Unit of Measure: Liters/day
0.1571  (0.04734) 0.1718  (0.04942) 0.1182  (0.05474)
14.Secondary Outcome
Title PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1
Hide Description 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
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Part 1 - AIN457A 10 mg/kg
Hide Arm/Group Description:
AIN457A 10.0 mg/kg was administered intravenously as a single dose.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: Liters
6.121  (0.999)
15.Secondary Outcome
Title PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 and 2
Hide Description 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
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Parts 1 and 2 - AIN457A 10 mg/kg Part 1 and 2 - AIN457 1.0 mg/kg Part 1 and 2 - AIN457 0.1 mg/kg
Hide Arm/Group Description:
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.
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
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
Overall Number of Participants Analyzed 25 11 11
Mean (Standard Deviation)
Unit of Measure: Liters
6.055  (0.943) 6.481  (1.701) 5.827  (2.887)
16.Secondary Outcome
Title PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1
Hide Description 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
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Part 1 - AIN457A 10 mg/kg
Hide Arm/Group Description:
AIN457A 10.0 mg/kg was administered intravenously as a single dose.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: day
27.95  (5.624)
17.Secondary Outcome
Title PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 and 2
Hide Description 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
Time Frame Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Parts 1 and 2 - AIN457A 10 mg/kg Part 1 and 2 - AIN457 1.0 mg/kg Part 1 and 2 - AIN457 0.1 mg/kg
Hide Arm/Group Description:
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.
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
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
Overall Number of Participants Analyzed 25 11 11
Mean (Standard Deviation)
Unit of Measure: day
28.09  (5.994) 27.32  (7.234) 34.31  (6.656)
18.Secondary Outcome
Title Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2
Hide Description 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
Time Frame Baseline, day 8,15,29, week 6,8,10,12,16,20,24,28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Parts 1 and 2 - AIN457A 10 mg/kg Part 1 and 2 - AIN457 1.0 mg/kg Part 1 and 2 - AIN457 0.1 mg/kg Part 1 and 2 - Placebo
Hide Arm/Group Description:
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
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
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
Placebo to AIN457A was administered intravenously as a single dose
Overall Number of Participants Analyzed 28 12 12 6
Mean (Standard Deviation)
Unit of Measure: Score
Day 8 (n=28,12,12,5) -0.121  (0.7969) -0.117  (0.6293) -0.233  (0.9335) 0.240  (0.2966)
Day 15 (n=28,12,12,5) -0.200  (0.7364) -0.383  (0.5937) -0.350  (0.7775) 0.160  (0.8764)
Day 29 (n=28,12,11,6) -0.157  (0.8404) -0.417  (0.7259) -0.382  (1.0713) 0.100  (0.2098)
Week 6 (n=27,11,11,3) -0.281  (0.8138) -0.436  (0.7256) -0.291  (0.8961) 0.133  (0.6110)
Week 8 (n=26,11,11,3) -0.238  (0.8100) -0.518  (1.0925) -0.509  (0.9523) -0.133  (0.6110)
Week 10 (n=25,11,10,3) -0.376  (0.8686) -0.200  (0.9077) -0.400  (0.6325) -0.067  (0.4163)
Week 12 (n=25,12,11,3) -0.384  (0.8887) -0.267  (0.7738) -0.455  (0.9883) -0.200  (0.6928)
Week 16 (n=24,10,8,3) -0.200  (0.8299) -0.400  (0.7424) -0.550  (0.9304) 0.400  (0.8000)
Week 20 (n=21,9,6,3) -0.143  (0.9168) -0.356  (0.6064) -0.633  (1.0912) -0.200  (1.5875)
Week 24 (n=20,8,5,3) -0.250  (0.7564) 0.200  (0.5657) -0.800  (1.1045) 0.400  (0.7211)
Week 28 (n=28,11,11,5) -0.036  (0.7345) -0.182  (0.9527) -0.230  (0.8145) 0.400  (0.4690)
19.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2
Hide Description 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.
Time Frame Baseline, day 8,15,29,week 6,8,10,12,16,20,24,28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Parts 1 and 2 - AIN457A 10 mg/kg Part 1 and 2 - AIN457 1.0 mg/Kg Part 1 and 2 - AIN457 0.1 mg/kg Part 1 and 2 - Placebo
Hide Arm/Group Description:
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.
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
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
Placebo to AIN457A was administered intravenously as a single dose
Overall Number of Participants Analyzed 28 12 12 6
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score
Day 8 (n=28,12,11,6)
-1.7011
(-2.533 to -0.870)
-1.2793
(-2.559 to 0.001)
-1.2920
(-2.635 to 0.051)
-1.0837
(-2.737 to 0.570)
Day 15 (n=28,12,11,5)
-1.7094
(-2.485 to -0.934)
-2.1256
(-3.317 to -0.934)
-1.1263
(-2.376 to 0.124)
-0.6417
(-2.199 to 0.915)
Day 29 (n=28,12,11,6)
-2.2530
(-3.096 to -1.410)
-2.4237
(-3.722 to -1.126)
-1.3886
(-2.750 to -0.028)
-0.7839
(-2.464 to 0.896)
Week 6 (n=26,11,11,3)
-1.8713
(-2.691 to -1.051)
-2.0151
(-3.275 to -0.755)
-1.2002
(-2.514 to 0.113)
-1.0577
(-2.893 to 0.777)
Week 8 (n=26,11,11,3)
-1.3863
(-2.189 to -0.584)
-1.6994
(-2.933 to -0.466)
-1.2020
(-2.485 to 0.081)
-1.4619
(-3.401 to 0.477)
Week 10 (n=24,11,9,3)
-1.6246
(-2.389 to -0.860)
-1.7402
(-2.909 to -0.571)
-1.0800
(-2.313 to 0.153)
-0.8527
(-2.558 to 0.853)
Week 12 (n=24,12,11,3)
-1.4744
(-2.336 to -0.613)
-1.3755
(-2.688 to -0.063)
-1.6834
(-3.059 to -0.307)
-1.3529
(-3.354 to 0.648)
Week 16 (n=24,10,8,3)
-1.3990
(-2.237 to -0.562)
-2.3081
(-3.589 to -1.027)
-1.7628
(-3.143 to -0.383)
-1.4083
(-3.415 to 0.598)
Week 20 (n=21,9,6,3)
-1.2072
(-2.011 to -0.403)
-1.4070
(-2.632 to -0.183)
-1.1596
(-2.521 to 0.202)
-1.5864
(-3.385 to 0.212)
Week 24 (n=20,8,5,3)
-1.1318
(-2.001 to -0.262)
-1.0035
(-2.343 to 0.336)
-0.8020
(-2.305 to 0.701)
-1.2048
(-3.201 to 0.792)
Week 28 (n=28,11,11,5)
-0.7373
(-1.487 to 0.012)
-0.8980
(-2.057 to 0.261)
-1.2227
(-2.432 to -0.013)
-0.9722
(-2.526 to 0.582)
20.Secondary Outcome
Title Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1
Hide Description 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).
Time Frame Baseline, day 8,15,29,week, 6, 8,10,12,16,20,24,28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Part 1 - AIN457A 10 mg/kg Part 1 - Placebo
Hide Arm/Group Description:
AIN457A 10.0 mg/kg was administered intravenously as a single dose.
Placebo to AIN457A was administered intravenously as a single dose
Overall Number of Participants Analyzed 23 6
Mean (Standard Deviation)
Unit of Measure: Score
Day 8 (n=23,6) -1.3  (2.46) 0.7  (1.37)
Day 15 (n=23,5) -1.3  (2.53) 2.4  (2.51)
Day 29 (n=23,6) -1.0  (2.80) -0.3  (1.97)
Week 6 (n=22,3) -1.5  (3.10) -0.3  (0.58)
Week 8 (n=21,3) -1.0  (2.77) 0.0  (0.0)
Week 10 (n=20,3) -1.3  (3.24) -0.3  (0.58)
Week 12 (n=20,3) -1.2  (3.09) -0.3  (0.58)
Week 16 (n=30,3) -0.9  (3.69) -0.3  (0.58)
Week 20 (n=18,3) 0.2  (3.55) 0.3  (1.53)
Week 24 (n=17,3) -1.3  (2.11) -0.3  (0.58)
Week 28 (n=23,5) -0.4  (3.86) 1.2  (1.30)
21.Secondary Outcome
Title Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2
Hide Description 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).
Time Frame Day 8,15,29,week, 6, 10,12,16,20,24,28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Parts 1 and 2 - AIN457A 10 mg/kg Part 1 and 2 - AIN457 1.0 mg/kg Part 1 and 2 - AIN457 0.1 mg/kg Part 1 and 2 - Placebo
Hide Arm/Group Description:
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.
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
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
Placebo to AIN457A was administered intravenously as a single dose
Overall Number of Participants Analyzed 28 12 12 6
Mean (Standard Deviation)
Unit of Measure: Score
Day 8 (n=28,12,12,6) -1.321  (2.7763) -1.917  (2.2344) -0.583  (1.0836) 0.667  (1.3663)
Day 15 (n=28,12,12,5) -1.393  (2.7667) -1.167  (1.9924) -1.167  (1.9462) 2.400  (2.5100)
Day 29 (n=28,12,11,6) -1.143  (2.9779) -2.083  (2.2344) -0.545  (0.6876) -0.333  (1.9664)
Week 6 (n=27,11,11,3) -1.556  (3.2026) -0.339  (3.1318) -0.364  (1.0269) -0.333  (0.5774)
Week 8 (n=26,11,11,3) -1.154  (2.9758) -1.273  (1.6787) 0.455  (2.2523) 0.0  (0.0)
Week 10 (n=25,11,10,3) -1.360  (3.3277) -1.091  (3.1450) -0.800  (0.9189) -0.333  (0.5774)
Week 12 (n=25,12,11,3) -1.280  (3.2342) -1.167  (4.1304) -0.636  (1.8040) -0.333  (0.5774)
Week 16 (n=24,10,8,3) -1.042  (3.7819) -0.600  (3.4705) 0.500  (1.6903) -0.333  (0.5774)
Week 20 (n=21,9,6,3) -0.238  (3.8458) -0.333  (3.7749) -0.667  (1.3663) 0.333  (1.5275)
Week 24 (n=20,8,5,3) -1.400  (2.2572) -1.000  (3.7417) 0.600  (1.9494) -0.333  (0.5774)
22.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame SF-36:Baseline, week 12, week 28; ASQoL: Baseline, Day 29, week 12, week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Part 1 - AIN457A 10 mg/kg Part 1 - Placebo
Hide Arm/Group Description:
AIN457A 10.0 mg/kg was administered intravenously as a single dose.
Placebo to AIN457A was administered intravenously as a single dose
Overall Number of Participants Analyzed 23 6
Mean (Standard Deviation)
Unit of Measure: Score
Baseline SF36 Mental component (n= 22,6) 38.71  (10.78) 39.57  (14.63)
Baseline SF36 physical component (n=22,6) 31.42  (5.2) 30.11  (6.71)
Week 12 SF36 Mental component (n=20,3) 43.45  (10.56) 56.57  (5.39)
Week 12 SF36 Physical component (n=20,3) 32.84  (6.39) 28.95  (1.8)
Week 28 SF36 Mental component (n=21,4) 41.65  (9.86) 40.51  (15.22)
Week 28 SF36 Physical component (n=21,4) 32.2  (5.68) 33.96  (8.73)
Change from Baseline to Day 29 ASQoL (n=21,6) -2.9  (4.04) -0.7  (2.58)
Change from Baseline to Week 12 ASQoL (n=18,3) -2.3  (3.05) 0.0  (1.00)
Change from Baseline to Week 28 ASQoL (n=20,4) -1.2  (3.71) -1.3  (2.06)
23.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame SF-36: Baseline, week 12, week 28; ASQoL: Baseline, day 29, week 12, week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Parts 1 and 2 - AIN457A 10 mg/kg Part 1 and 2 - AIN457 1.0 mg/kg Part 1 and 2 - AIN457 0.1 mg/kg Part 1 and 2 - Placebo
Hide Arm/Group Description:
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.
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
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
Placebo to AIN457A was administered intravenously as a single dose
Overall Number of Participants Analyzed 28 12 12 6
Mean (Standard Deviation)
Unit of Measure: Score
Baseline SF36 Mental component (n=27,12,12,6) 38.97  (10.91) 39.46  (11.95) 51.9  (8.7) 39.57  (14.63)
Baseline SF36 Physical component (n=27,12,12,6) 30.95  (6.34) 26.17  (7.63) 33.53  (7.47) 30.11  (6.71)
Week 12 SF36 Mental component (n=25,11,10,3) 44.37  (11.05) 38.45  (10.13) 49.7  (11.74) 56.57  (5.39)
Week 12 SF36 Physical component (n=25,11,10,3) 32.71  (6.24) 31.3  (7.67) 35.81  (5.29) 28.05  (1.8)
Week 28 SF36 Mental component (n=26,11,10,4) 40.94  (10.56) 36.6  (10.3) 46.96  (9.67) 40.51  (15.22)
Week 28 SF36 Physical component (n=26,11,10,4) 31.85  (5.3) 29.95  (6.92) 35.54  (5.9) 33.96  (8.73)
Change from Baseline to Day 29 ASQoL(n=26,11,10,6) -3.2  (3.78) -3.1  (2.63) -0.7  (2.26) -0.7  (2.58)
Change from Baseline to Week 12 ASQoL(n=23,11,9,3) -2.7  (2.91) -2.7  (4.71) -1.3  (3.16) 0.0  (1.00)
Change from Baseline to Week 28 ASQoL(n=25,11,9,4) -1.4  (3.37) -1.3  (3.66) -0.9  (2.15) -1.3  (2.06)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AIN457 2x10mg/kg AIN457 2x1.0mg/kg AIN457 2x0.1mg/kg Placebo
Hide Arm/Group Description 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 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 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 Placebo to AIN457A was administered intravenously as a single dose
All-Cause Mortality
AIN457 2x10mg/kg AIN457 2x1.0mg/kg AIN457 2x0.1mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AIN457 2x10mg/kg AIN457 2x1.0mg/kg AIN457 2x0.1mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/30 (6.67%)   1/12 (8.33%)   0/12 (0.00%)   1/6 (16.67%) 
Immune system disorders         
Anaphylactic reaction  1  1/30 (3.33%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%) 
Infections and infestations         
Cytomegalovirus infection  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Subcutaneous abscess  1  1/30 (3.33%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%) 
Investigations         
Blood pressure increased  1  0/30 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AIN457 2x10mg/kg AIN457 2x1.0mg/kg AIN457 2x0.1mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   27/30 (90.00%)   10/12 (83.33%)   9/12 (75.00%)   5/6 (83.33%) 
Blood and lymphatic system disorders         
Anaemia  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Cardiac disorders         
Cardiovascular insufficiency  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Palpitations  1  0/30 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/6 (16.67%) 
Ear and labyrinth disorders         
Vertigo  1  2/30 (6.67%)  1/12 (8.33%)  0/12 (0.00%)  1/6 (16.67%) 
Eye disorders         
Eye swelling  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Vision blurred  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Vitreous floaters  1  0/30 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/6 (0.00%) 
Gastrointestinal disorders         
Abdominal discomfort  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Abdominal pain  1  1/30 (3.33%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Abdominal pain upper  1  2/30 (6.67%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%) 
Aphthous stomatitis  1  1/30 (3.33%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Colitis  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Diarrhoea  1  7/30 (23.33%)  0/12 (0.00%)  2/12 (16.67%)  0/6 (0.00%) 
Frequent bowel movements  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Gastrointestinal haemorrhage  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Gastrooesophageal reflux disease  1  0/30 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  1/6 (16.67%) 
Mouth ulceration  1  2/30 (6.67%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%) 
Nausea  1  6/30 (20.00%)  1/12 (8.33%)  1/12 (8.33%)  1/6 (16.67%) 
Oral mucosal eruption  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Pancreatic enlargement  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Stomatitis  1  1/30 (3.33%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Vomiting  1  1/30 (3.33%)  1/12 (8.33%)  0/12 (0.00%)  1/6 (16.67%) 
General disorders         
Chills  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  1/6 (16.67%) 
Fatigue  1  3/30 (10.00%)  0/12 (0.00%)  3/12 (25.00%)  1/6 (16.67%) 
Influenza like illness  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Malaise  1  2/30 (6.67%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%) 
Pain  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Pyrexia  1  5/30 (16.67%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%) 
Temperature intolerance  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Infections and infestations         
Bronchitis  1  2/30 (6.67%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%) 
Fungal skin infection  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Gastroenteritis  1  2/30 (6.67%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%) 
Gastroenteritis viral  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Influenza  1  3/30 (10.00%)  1/12 (8.33%)  1/12 (8.33%)  0/6 (0.00%) 
Nasopharyngitis  1  8/30 (26.67%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Oral candidiasis  1  2/30 (6.67%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Oral herpes  1  2/30 (6.67%)  0/12 (0.00%)  0/12 (0.00%)  1/6 (16.67%) 
Otitis externa  1  2/30 (6.67%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%) 
Otitis media  1  1/30 (3.33%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Pharyngitis  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Rhinitis  1  2/30 (6.67%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%) 
Sinusitis  1  1/30 (3.33%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Upper respiratory tract infection  1  2/30 (6.67%)  1/12 (8.33%)  1/12 (8.33%)  0/6 (0.00%) 
Vulvovaginal mycotic infection  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Injury, poisoning and procedural complications         
Epicondylitis  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Limb injury  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Investigations         
Aortic bruit  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Metabolism and nutrition disorders         
Hypercholesterolaemia  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Hypomagnesaemia  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders         
Ankylosing spondylitis  1  1/30 (3.33%)  0/12 (0.00%)  1/12 (8.33%)  2/6 (33.33%) 
Arthralgia  1  4/30 (13.33%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%) 
Back pain  1  3/30 (10.00%)  0/12 (0.00%)  1/12 (8.33%)  1/6 (16.67%) 
Bone pain  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Bone swelling  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Groin pain  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Joint swelling  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Muscular weakness  1  0/30 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/6 (0.00%) 
Musculoskeletal chest pain  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Myalgia  1  2/30 (6.67%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%) 
Pain in extremity  1  1/30 (3.33%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Tendon calcification  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Tendonitis  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Nervous system disorders         
Burning sensation  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Dizziness  1  3/30 (10.00%)  1/12 (8.33%)  0/12 (0.00%)  1/6 (16.67%) 
Dysaesthesia  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Dysgeusia  1  2/30 (6.67%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Headache  1  7/30 (23.33%)  1/12 (8.33%)  3/12 (25.00%)  0/6 (0.00%) 
Paraesthesia  1  3/30 (10.00%)  1/12 (8.33%)  0/12 (0.00%)  1/6 (16.67%) 
Sinus headache  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Tremor  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Psychiatric disorders         
Insomnia  1  1/30 (3.33%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Sleep disorder  1  0/30 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/6 (16.67%) 
Renal and urinary disorders         
Hydronephrosis  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  2/30 (6.67%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Dyspnoea  1  1/30 (3.33%)  1/12 (8.33%)  2/12 (16.67%)  0/6 (0.00%) 
Oropharyngeal pain  1  3/30 (10.00%)  1/12 (8.33%)  1/12 (8.33%)  0/6 (0.00%) 
Sinus congestion  1  1/30 (3.33%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders         
Dyshidrosis  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Eczema  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Photosensitivity reaction  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Pruritus  1  2/30 (6.67%)  0/12 (0.00%)  1/12 (8.33%)  1/6 (16.67%) 
Rash maculo-papular  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Skin irritation  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Urticaria  1  0/30 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%) 
Vascular disorders         
Circulatory collapse  1  2/30 (6.67%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%) 
Flushing  1  0/30 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00809159     History of Changes
Other Study ID Numbers: CAIN457A2209
2008-002631-33
First Submitted: December 16, 2008
First Posted: December 17, 2008
Results First Submitted: January 29, 2015
Results First Posted: September 18, 2015
Last Update Posted: December 9, 2015