A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis - Study Results

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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
Number of Participants [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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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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 ]

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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 ]

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7. Secondary:

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

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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 ]

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9. Secondary:

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

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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 ]

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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 ]

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12. Secondary:

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

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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 ]

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14. Secondary:

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

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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 ]

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16. Secondary:

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

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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 ]

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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Disclosure agreements vary; the Medical Institution shall not disclose any material/information disclosed by Abbott Japan in connection with the Clinical Research or information obtained by conducting the Clinical Research to third parties without Abbott Japan's prior written approval. When Medical Institution intends to publish information obtained by conducting Clinical Research, Institution shall obtain Abbott Japan's prior written approval.

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
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Results Point of Contact:

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

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT00667355 History of Changes
Other Study ID Numbers:	M10-239
Study First Received:	April 24, 2008
Results First Received:	May 28, 2010
Last Updated:	January 24, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare