Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AbbVie ( AbbVie (prior sponsor, Abbott) )

ClinicalTrials.gov Identifier:

NCT01077258

First received: February 25, 2010

Last updated: April 9, 2014

Last verified: April 2014

History of Changes

Results First Received: February 28, 2014

Study Type:	Observational
Study Design:	Observational Model: Case-Only; 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
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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
Rheumatoid Arthritis	Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.

Participant Flow: Overall Study

	Rheumatoid Arthritis
STARTED	4208
COMPLETED	1640
NOT COMPLETED	2568
Lost to Follow-up	1390
Adverse drug reaction	218
Lack of Efficacy	663
Clinical remission	37
Other reasons	260

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.
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Reporting Groups

	Description
Rheumatoid Arthritis	Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.

Baseline Measures

	Rheumatoid Arthritis
Number of Participants [units: participants]	4208
Age ^[1] [units: years] Mean (Standard Deviation)	54.6 (13.2)
Gender ^[2] [units: participants]
Female	3199
Male	958
Region of Enrollment [units: participants]
Germany	4208

[1]	Age data was available for 4147 participants
[2]	Gender data available for 4157 participants

Outcome Measures

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1. Primary:

Change From Baseline in Disease Activity Score (DAS) 28 [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]

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2. Primary:

Percentage of Participants in DAS28 Remission [ Time Frame: Months 3, 6, 9, 12, 18, and 24 ]

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3. Secondary:

Percentage of Participants With a Significant Therapeutic Response [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]

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4. Secondary:

Percentage of Participants With Low, Moderate and High Disease Activity [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]

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5. Secondary:

Erythrocyte Sedimentation Rate (ESR) Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]

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6. Secondary:

C-Reactive Protein (CRP) Levels Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]

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7. Secondary:

Tender Joint Count (TJC) Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]

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8. Secondary:

Swollen Joint Count (SJC) Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]

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9. Secondary:

Hannover Functional Questionnaire (FFbH) Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]

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10. Secondary:

Patients Global Assessment of Disease Activity Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18 and 24 ]

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11. Secondary:

Participants Assessment of Fatigue Over Time [ Time Frame: Baseline and Month 3, 6, 9, 12, 18, and 24 ]

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12. Secondary:

Participants Assessment of Pain Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]

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13. Secondary:

Percentage of Participants With Impairment in Daily Activities [ Time Frame: Baseline and Months 3, 6, 9, 18, and 24 ]

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14. Secondary:

Number of Days Missed From Work Due to Rheumatoid Arthritis [ Time Frame: Baseline and Months 6, 12, 18, and 24 ]

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15. Secondary:

Percentage of Participants With In-patient Hospitalization [ Time Frame: Month 6, 12, 18, and 24 ]

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16. Secondary:

Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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: AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.

Results Point of Contact:

Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT01077258 History of Changes
Other Study ID Numbers:	P10-448
Study First Received:	February 25, 2010
Results First Received:	February 28, 2014
Last Updated:	April 9, 2014
Health Authority:	Germany: Paul-Ehrlich-Institut

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