Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3)

This study has been terminated.

(Study enrollment was stopped due to insufficient subject accrual.)

Sponsor:

Collaborator:

Integrated Therapeutics Group

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00394589

First received: October 31, 2006

Last updated: February 3, 2010

Last verified: February 2010

History of Changes

Results First Received: October 28, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Interventions:	Drug: Infliximab Increased Frequency Drug: Infliximab Increased Dose Drug: Infliximab Control

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Increased Dose	3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
Increased Frequency	Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
Control	Continuation of infliximab 3 mg/kg every 8 weeks

Participant Flow: Overall Study

	Increased Dose	Increased Frequency	Control
STARTED	14	11	18
COMPLETED	6	8	11
NOT COMPLETED	8	3	7
Adverse Event	2	1	2
Lack of Efficacy	2	2	3
Protocol Violation	4	0	2

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Increased Dose	3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
Increased Frequency	Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
Control	Continuation of infliximab 3 mg/kg every 8 weeks
Total	Total of all reporting groups

Baseline Measures

	Increased Dose	Increased Frequency	Control	Total
Number of Participants [units: participants]	14	11	18	43
Age [units: years] Mean ± Standard Deviation	58.7 ± 13.0	58.6 ± 16.1	57.7 ± 12.3	58.3 ± 13.3
Gender [units: participants]
Female	11	9	14	34
Male	3	2	4	9

Outcome Measures

1. Primary:

Change in Disease Activity Score Based on 28 Joint Count (DAS28) Score. [ Time Frame: Between Screening (Week <=1) and Week 24 ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.

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:	NCT00394589 History of Changes
Other Study ID Numbers:	P04249
Study First Received:	October 31, 2006
Results First Received:	October 28, 2009
Last Updated:	February 3, 2010
Health Authority:	Austria: Federal Ministry for Health and Women Belgium: Ministry of Social Affairs, Public Health and the Environment Denmark: Danish Medicines Agency France: Ministry of Health Germany: Paul-Ehrlich-Institut Greece: Ministry of Health and Welfare Netherlands: Medicines Evaluation Board (MEB) Norway: Norwegian Medicines Agency Portugal: National Pharmacy and Medicines Institute Sweden: Medical Products Agency Turkey: Ministry of Health

To Top