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A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs

This study has been terminated.
(Recruitment halted: Failed to achieve efficacy)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01209702
First Posted: September 27, 2010
Last Update Posted: February 11, 2013
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
Results First Submitted: November 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Spondylitis, Ankylosing
Interventions: Biological: tocilizumab
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In Part 1, patients were randomized in a 1:1 ratio to placebo or tocilizumab (TCZ) 8 mg/kg. In Part 2, patients were randomized in a 2:1:1 ratio to TCZ 8 mg/kg, TCZ 4 mg/kg, or placebo, respectively. Due to the early stopping of the study and limitations in available data the TCZ dose groups in Part 2 were combined.

Reporting Groups
  Description
Part 1: Placebo Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
Part 1: Tocilizumab Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
Part 2: Placebo Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
Part 2: Tocilizumab Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.

Participant Flow:   Overall Study
    Part 1: Placebo   Part 1: Tocilizumab   Part 2: Placebo   Part 2: Tocilizumab
STARTED   51   51   51   153 
Treated   51   51   51   152 
Escape or Switched to Tocilizumab   51   0   6   0 
Completed 12 Weeks Treatment   50   48   12   59 
Completed 24 Weeks Treatment   19   28   3   10 
COMPLETED   0   0   0   0 
NOT COMPLETED   51   51   51   153 



  Baseline Characteristics
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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
Combined Placebo Participants in Part 1 and Part 2 who received intravenous infusions of placebo once every 4 weeks.
Combined Tocilizumab Participants randomized in Part 1 and Part 2 to receive intravenous infusions of 4 mg/kg (in Part 2 only) or 8 mg/kg tocilizumab once every 4 weeks.
Total Total of all reporting groups

Baseline Measures
   Combined Placebo   Combined Tocilizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 102   203   305 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 41.2  (11.33)   40.4  (11.42)   40.7  (11.38) 
[1] Demographic data are provided for all participants who received at least one tocilizumab/placebo infusion.
Gender 
[Units: Participants]
     
Female   29   53   82 
Male   73   150   223 
Age - Part 1 population [1] 
[Units: Years]
Mean (Standard Deviation)
 42.7  (12.64)   41.6  (11.22)   42.1  (11.91) 
[1] Demographic data for the Part 1 population: Placebo = 51 participants, Tocilizumab = 51 participants, total = 102 participants.
Gender - Part 1 Population [1] 
[Units: Participants]
     
Female   11   15   26 
Male   40   36   76 
[1] Demographic data for the Part 1 population: Placebo = 51 participants, Tocilizumab = 51 participants, total = 102 participants.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Part 1: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Primary:   Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12   [ Time Frame: Baseline and Week 12 ]

3.  Secondary:   Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 24   [ Time Frame: Baseline and Week 24 ]

4.  Secondary:   Percentage of Participants Who Achieved a Value <2 in Each of the 4 ASAS Parameters at Week 12   [ Time Frame: Week 12 ]

5.  Secondary:   Percentage of Participants Achieving a 40% Improvement in Assessment in Ankylosing Spondylitis (ASAS40) at Week 12   [ Time Frame: Baseline and Week 12 ]

6.  Secondary:   Part 2: Percentage of Participants Achieving a 40% Improvement in Assessment in Ankylosing Spondylitis (ASAS40) at Week 24   [ Time Frame: Baseline and Week 24 ]

7.  Secondary:   Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)   [ Time Frame: Baseline and Week 12 ]

8.  Secondary:   Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)   [ Time Frame: Baseline and Week 12 ]

9.  Secondary:   Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)   [ Time Frame: Baseline and Week 12 ]

10.  Secondary:   Change From Baseline in C-Reactive Protein   [ Time Frame: Baseline and Week 12 ]

11.  Secondary:   Part 2: Area Under the Plasma Concentration Versus Time Curve of Tocilizumab   [ Time Frame: Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion). ]

12.  Secondary:   Part 2: Peak Plasma Concentration of Tocilizumab   [ Time Frame: Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion). ]

13.  Secondary:   Part 2: Elimination Half-life of Tocilizumab   [ Time Frame: Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion). ]

14.  Secondary:   Part 2: Clearance of Tocilizumab   [ Time Frame: Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion). ]

15.  Secondary:   Part 2: Volume of Distribution of Tocilizumab   [ Time Frame: Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion). ]

16.  Secondary:   Change From Baseline in the Level of Interleukin-6   [ Time Frame: Baseline and Week 12 ]

17.  Secondary:   Change From Baseline in Level of Soluble Interleukin-6 Receptor   [ Time Frame: Baseline and Week 12 ]

18.  Secondary:   Number of Participants With Anti-tocilizumab Antibodies   [ Time Frame: From Baseline until end of study (a maximum treatment duration of 40 weeks). ]

19.  Secondary:   Part 2: Radiographic Change According to the Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)   [ Time Frame: Baseline and Week 104 ]

20.  Secondary:   Part 2: Percentage of Participants With a Reduction of Magnetic Resonance Imaging (MRI) Proven Spinal Inflammation   [ Time Frame: Baseline and Week 24 ]

21.  Secondary:   Part 1: The Number of Participants With Adverse Events   [ Time Frame: Up to 40 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01209702     History of Changes
Other Study ID Numbers: NA22823
2009-017443-34
First Submitted: September 24, 2010
First Posted: September 27, 2010
Results First Submitted: November 26, 2012
Results First Posted: February 11, 2013
Last Update Posted: February 11, 2013