ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 372 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Part 1 - AIN457A 10 mg/kg AIN457A 10.0 mg/kg was administered intravenously as a single dose.
Part 1 - Placebo Placebo to AIN457A was administered intravenously as a single dose
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.
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
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
Part 1 and 2 - Placebo Placebo to AIN457A was administered intravenously as a single dose

Participant Flow for 2 periods

Period 1:   Part 1
    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
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 
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 2:   Part 1 and 2
    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
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 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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
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
Part 1 and 2 - Placebo Placebo to AIN457A was administered intravenously as a single dose
Total Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 30   12   12   6   60 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.7  (9.69)   47.2  (10.50)   42.8  (9.17)   45.0  (9.96)   42.8  (9.88) 
Gender 
[Units: Participants]
         
Female   11   6   4   1   22 
Male   19   6   8   5   38 


  Outcome Measures

1.  Primary:   Percentage of Participants Who Achieved ASAS20 Response   [ Time Frame: 6 Weeks ]

2.  Primary:   Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to 6 Weeks After First Infusion in Part 2   [ Time Frame: 6 Weeks ]

3.  Secondary:   Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1   [ Time Frame: Day8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28 ]

4.  Secondary:   Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined   [ Time Frame: Day 8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28 ]

5.  Secondary:   Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1   [ Time Frame: Baseline, week 6, week 28 ]

6.  Secondary:   Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1   [ Time Frame: Week 28 ]

7.  Secondary:   Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 and 2   [ Time Frame: Week 28 ]

8.  Secondary:   PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1   [ Time Frame: Week 28 ]

9.  Secondary:   PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 and 2   [ Time Frame: Week 28 ]

10.  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   [ Time Frame: Week 28 ]

11.  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   [ Time Frame: Week 28 ]

12.  Secondary:   PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1   [ Time Frame: Week 28 ]

13.  Secondary:   PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 and 2   [ Time Frame: Week 28 ]

14.  Secondary:   PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1   [ Time Frame: Week 28 ]

15.  Secondary:   PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 and 2   [ Time Frame: Week 28 ]

16.  Secondary:   PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1   [ Time Frame: Week 28 ]

17.  Secondary:   PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 and 2   [ Time Frame: Week 28 ]

18.  Secondary:   Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2   [ Time Frame: Baseline, day 8,15,29, week 6,8,10,12,16,20,24,28 ]

19.  Secondary:   Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2   [ Time Frame: Baseline, day 8,15,29,week 6,8,10,12,16,20,24,28 ]

20.  Secondary:   Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1   [ Time Frame: Baseline, day 8,15,29,week, 6, 8,10,12,16,20,24,28 ]

21.  Secondary:   Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2   [ Time Frame: Day 8,15,29,week, 6, 10,12,16,20,24,28 ]

22.  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.   [ Time Frame: SF-36:Baseline, week 12, week 28; ASQoL: Baseline, Day 29, week 12, week 28 ]

23.  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.   [ Time Frame: SF-36: Baseline, week 12, week 28; ASQoL: Baseline, day 29, week 12, week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis
phone: 862-778-8300


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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