Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00724243

First received: July 25, 2008

Last updated: March 5, 2010

Last verified: March 2010

History of Changes

Results First Received: January 28, 2010

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

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
Infliximab	Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.

Participant Flow: Overall Study

	Infliximab
STARTED	33
COMPLETED	18
NOT COMPLETED	15
Lack of Efficacy	10
Adverse Event	5

Baseline Characteristics

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Reporting Groups

	Description
Infliximab	Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.

Baseline Measures

	Infliximab
Number of Participants [units: participants]	33
Age [units: years] Mean ± Standard Deviation	43.38 ± 10.74
Gender [units: participants]
Female	26
Male	7
Region of Enrollment [units: participants]
Slovakia	33

Outcome Measures

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1. Primary:

Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment [ Time Frame: Baseline, Week 14, and Week 54 ]

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2. Primary:

Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria [ Time Frame: Week 14 and Week 54 ]

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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: Contractor agrees to acknowledge his contractual relationship with Sponsor in his lecturing or publication activities in relation to subject matter and/or in relation to any other matter concerning Sponsor. However, unless Sponsor’s prior consent was given, Contractor shall not specify in more detail the content or subject matter of his contract. Contractor shall not publish or provide to 3rd parties for publication purposes any results of his activities without Sponsor’s prior written consent.

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: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00724243 History of Changes
Other Study ID Numbers:	P04741
Study First Received:	July 25, 2008
Results First Received:	January 28, 2010
Last Updated:	March 5, 2010
Health Authority:	Slovakia: State Institute for Drug Control

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