Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

This study has been completed.

Sponsor:

Collaborators:

Abbott Japan Co.,Ltd

Eisai Co., Ltd.

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00235833

First received: October 7, 2005

Last updated: April 7, 2011

Last verified: April 2011

History of Changes

Results First Received: October 12, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Intervention:	Biological: adalimumab

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
Japanese subjects with moderate to severe rheumatoid arthritis (RA) in relatively good physical health excluding RA symptoms and who completed a preceding continuous repeated administration study of adalimumab (DE035X/D2E7-J081-003) who wished to continue treatment until approval of adalimumab in Japan.

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 40 mg Eow	Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.

Participant Flow: Overall Study

	Adalimumab 40 mg Eow
STARTED	25
COMPLETED	9
NOT COMPLETED	16

Baseline Characteristics

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Reporting Groups

	Description
Adalimumab 40 mg Eow	Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.

Baseline Measures

	Adalimumab 40 mg Eow
Number of Participants [units: participants]	25
Age [units: years] Mean ± Standard Deviation	54.1 ± 11.1
Gender [units: participants]
Female	21
Male	4
Region of Enrollment [units: participants]
Japan	25

Outcome Measures

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1. Primary:

Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ]

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2. Secondary:

Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ]

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3. Secondary:

Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ]

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4. Secondary:

Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ]

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5. Secondary:

Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ]

Show Outcome Measure 5

6. Secondary:

Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ]

Show Outcome Measure 6

7. Secondary:

Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ]

Show Outcome Measure 7

8. Secondary:

Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit. [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ]

Show Outcome Measure 8

9. Secondary:

Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response) [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter ]

Show Outcome Measure 9

10. Secondary:

Number of Subjects With Morning Stiffness at Each Visit [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ]

Show Outcome Measure 10

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; most restrictive agreement states Medical Institution shall not disclose materials/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 the Clinical Research, Medical 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
Due to the small population, statistical tests were not performed.

Results Point of Contact:

Name/Title: Medical Information Specialist
Organization: Abbott
phone: 800-633-9110

No publications provided

Responsible Party:	Eiichi Makino, Abbott
ClinicalTrials.gov Identifier:	NCT00235833 History of Changes
Other Study ID Numbers:	M02-564
Study First Received:	October 7, 2005
Results First Received:	October 12, 2009
Last Updated:	April 7, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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