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Trial record 5 of 372 for:    Ankylosing Spondylitis

A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT00667355
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : August 11, 2010
Last Update Posted : January 26, 2012
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Abbott

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Ankylosing Spondylitis
Intervention: Biological: adalimumab

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Adalimumab Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.

Participant Flow:   Overall Study
    Adalimumab
STARTED   41 
COMPLETED   30 
NOT COMPLETED   11 
Adverse Event                5 
Lost to Follow-up                1 
Other reason was not specified                5 



  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
Adalimumab Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.

Baseline Measures
   Adalimumab 
Overall Participants Analyzed 
[Units: Participants]
 41 
Age, Customized 
[Units: Subjects]
 
<40 years   25 
Between 40 and 65 years   16 
>65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.2  (12.17) 
Gender 
[Units: Subjects]
 
Female   9 
Male   32 
Region of Enrollment 
[Units: Subjects]
 
Japan   41 


  Outcome Measures

1.  Primary:   Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Number of Subjects Achieving ASAS 20   [ Time Frame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

3.  Secondary:   Number of Subjects Achieving ASAS 50   [ Time Frame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

4.  Secondary:   Number of Subjects Achieving ASAS 70   [ Time Frame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

5.  Secondary:   Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)   [ Time Frame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

6.  Secondary:   Mean Change From Baseline in Patient's Global Assessment of Disease Activity   [ Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

7.  Secondary:   Mean Change From Baseline in Total Back Pain   [ Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

8.  Secondary:   Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)   [ Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

9.  Secondary:   Mean Change From Baseline in C-Reactive Protein (CRP)   [ Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

10.  Secondary:   Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.   [ Time Frame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

11.  Secondary:   Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40)   [ Time Frame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

12.  Secondary:   Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission   [ Time Frame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

13.  Secondary:   Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)   [ Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

14.  Secondary:   Mean Change From Baseline in Chest Expansion   [ Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

15.  Secondary:   Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)   [ Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

16.  Secondary:   Mean Change From Baseline in Nocturnal Pain   [ Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

17.  Secondary:   Mean Change From Baseline in Swollen Joint Count for 44 Joints (SJC 44)   [ Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

18.  Secondary:   Mean Change From Baseline in Tender Joint Count for 46 Joints (TJC 46)   [ Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]

19.  Secondary:   Mean Change From Baseline in 36-Item Short Form (SF-36) Questionnaire   [ Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit ]


  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: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110



Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00667355     History of Changes
Other Study ID Numbers: M10-239
First Submitted: April 24, 2008
First Posted: April 28, 2008
Results First Submitted: May 28, 2010
Results First Posted: August 11, 2010
Last Update Posted: January 26, 2012