A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)(COMPLETED) (REQUEST)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00741104

First received: July 30, 2008

Last updated: September 24, 2009

Last verified: September 2009

History of Changes

Results First Received: June 11, 2009

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
Information about patients' doctor visits prior to this study were obtained from the Swedish Rheumatology Register and the South Swedish Arthritis Treatment Group.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
RA patients in Sweden normally see their doctor every 6 months. Information obtained from these visits are entered into national registries. Data in this study were based on retrospective review of the two visits preceding the study visit and the visit when infliximab was prescribed for the 1st time, as well as the one and only study visit.

Reporting Groups

	Description
RA Patients	Patients on maintenance therapy for rheumatoid arthritis (RA) with infliximab for >= the past 12 months.

Participant Flow: Overall Study

	RA Patients
STARTED	363
COMPLETED	363
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
RA Patients	Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.

Baseline Measures

	RA Patients
Number of Participants [units: participants]	363
Age [units: years] Mean ( Full Range )	61 ( 23 to 89 )
Gender [units: participants]
Female	254
Male	109
Region of Enrollment [units: participants]
Sweden	363
Change in dosing interval since previous doctor visit ^[1] [units: participants]
Decreased dosing interval	19
No change	226
Increased dosing interval	19
Data unavailable	99

[1]	Only 264 patients had this information available from the registry databases.

Outcome Measures

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1. Primary:

Dosing Interval Between the Infliximab Infusions [ Time Frame: Measured from the Remicade Questionnaire at first (and only) study visit ]

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2. Primary:

Reason for Extending Dosing Interval [ Time Frame: Measured from the Remicade Questionnaire at first (and only) study visit ]

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3. Primary:

Patient Response to Increased Dosing Interval [ Time Frame: Measured from the Remicade Questionnaire at first (and only) study visit ]

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4. Primary:

Number of Patients Agreeing to Participate in a Dose Reduction Study [ Time Frame: Measured from the Remicade Questionnaire at first (and only) study visit ]

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Measure Type	Primary
Measure Title	Number of Patients Agreeing to Participate in a Dose Reduction Study
Measure Description	As part of the Remicade questionnaire, patients were asked "would you consider participating in a dose reduction study?"
Time Frame	Measured from the Remicade Questionnaire at first (and only) study visit
Safety Issue	No

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.
Out of the 363 subjects in the analysis, 361 subjects answered this question.

Reporting Groups

	Description
RA Patients	Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.

Measured Values

	RA Patients
Number of Participants Analyzed [units: participants]	361
Number of Patients Agreeing to Participate in a Dose Reduction Study [units: participants]
no	139
yes	222

No statistical analysis provided for Number of Patients Agreeing to Participate in a Dose Reduction Study

5. Secondary:

Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage. [ Time Frame: Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry. ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

6. Secondary:

Adverse Events (AEs) [ Time Frame: Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry. ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

7. Secondary:

Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire. [ Time Frame: Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry. ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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: PI agrees not to publish/publicly present any interim results of the Study. PI further agrees to provide 45 days written notice to Sponsor prior to submission for publication/presentation to permit Sponsor to review drafts of any material before publication which report any results arising out of the Study. Sponsor shall have the right to review and comment.

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: 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:	NCT00741104 History of Changes
Other Study ID Numbers:	P05417
Study First Received:	July 30, 2008
Results First Received:	June 11, 2009
Last Updated:	September 24, 2009
Health Authority:	Sweden: Medical Products Agency

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