RESTART C0168Z05 Rheumatoid Arthritis Study

This study has been completed.

Study NCT00714493 Information provided by Centocor Ortho Biotech Services, L.L.C.

First Received on July 10, 2008. Last Updated on January 14, 2011 History of Changes

Results First Received: January 14, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Intervention:	Biological: 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	Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response

Participant Flow: Overall Study

	Infliximab
STARTED	203
COMPLETED	154
NOT COMPLETED	49
Adverse Event	11
Death	3
Lack of Efficacy	10
Lost to Follow-up	3
Protocol Violation	12
SUBJECT CHOICE (SUBJECT WITHDREW CONSENT	8
OTHER	2

Baseline Characteristics

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Reporting Groups

	Description
Infliximab	Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response

Baseline Measures

	Infliximab
Number of Participants [units: participants]	203
Age [units: participants]
<=18 years	0
Between 18 and 65 years	171
>=65 years	32
Age [units: years] Mean ± Standard Deviation	54 ± 12.07
Gender [units: participants]
Female	161
Male	42
Region of Enrollment [units: participants]
Europe	43
North America	160

Outcome Measures

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1. Primary:

Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10 [ Time Frame: Week 10 ]

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2. Secondary:

Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase [ Time Frame: Week 26 ]

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3. Secondary:

Percent of Patients Who Achieved EULAR Response at Week 26, Regardless of EULAR Response Status at Weeks 10, 14, and 22, With or Without Dose Increase Prior to Week 26 [ Time Frame: Week 26 ]

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4. Secondary:

Change From Baseline in Physical Function (HAQ) [ Time Frame: Week 10 ]

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5. Secondary:

Change From Baseline in Physical Function (HAQ) [ Time Frame: Week 26 ]

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6. Secondary:

Percent of Patients Who Achieved ACR20 at Week 10 [ Time Frame: Week 10 ]

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7. Secondary:

Percent of Patients Who Achieved ACR20 at Weeks 26. [ Time Frame: Week 26 ]

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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.

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: Sr. Director, Clinical Research - Medical Affairs
Organization: Centocor Ortho Biotech, Inc.
phone: 215-325-6811
e-mail: Ddeckto2@its.jnj.com

No publications provided

Responsible Party:	Sr. Dir., Medical Affairs Strategic Trials Team, Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00714493 History of Changes
Obsolete Identifiers:	NCT01281449
Other Study ID Numbers:	CR013879, C0168Z05
Study First Received:	July 10, 2008
Results First Received:	January 14, 2011
Last Updated:	January 14, 2011
Health Authority:	United States: Food and Drug Administration