Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Abbott

ClinicalTrials.gov Identifier:

NCT01076959

First received: February 25, 2010

Last updated: August 27, 2012

Last verified: August 2012

History of Changes

Results First Received: June 29, 2012

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Rheumatoid Arthritis

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
The sponsor was required to include all patients diagnosed with rheumatoid arthritis and who were treated Humira in routine medical practice during the review period by the Pharmaceuticals and Medical Devices Agency (PMDA).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was completed when the PMDA had completed their review. A total of 7972 patients were registered and case report forms were retrieved for 7891 patients; 151 patients were excluded from the analysis because the case report forms were either duplicated (n=150) or the patient was included in another survey (n=1).

Reporting Groups

	Description
Humira	Patients who received Humira for 24 weeks during the PMDA review period.

Participant Flow: Overall Study

	Humira
STARTED	7740
COMPLETED	5490
NOT COMPLETED	2250
Adverse Event	767
Lack of Efficacy	849
Non-compliance	274
Lost to Follow-up	241
Unknown	119

Baseline Characteristics

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Reporting Groups

	Description
Humira	Patients who received Humira for 24 weeks during the PMDA review period.

Baseline Measures

	Humira
Number of Participants [units: participants]	7740
Age [units: years] Mean ± Standard Deviation	60.1 ± 13.0
Age, Customized [units: participants]
<20 years	26
>=20-<30	165
>=30-<40	461
>=40-<50	828
>=50-<60	1803
>=60-<70	2515
>=70-<80	1676
>=80-<90	261
>=90	4
No data	1
Gender [units: participants]
Female	6388
Male	1352
Region of Enrollment [units: participants]
Japan	7740

Outcome Measures

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1. Primary:

Total Number of Patients With Adverse Events [ Time Frame: Baseline to Week 24 ]

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2. Primary:

Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4 [ Time Frame: Week 4 ]

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3. Primary:

Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12 [ Time Frame: Week 12 ]

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4. Primary:

Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24 [ Time Frame: Week 24 ]

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5. Secondary:

Physicians' Overall Effectiveness Response Rating [ Time Frame: Week 24 ]

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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: Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.

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.

Results Point of Contact:

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

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01076959 History of Changes
Other Study ID Numbers:	P10-559
Study First Received:	February 25, 2010
Results First Received:	June 29, 2012
Last Updated:	August 27, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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