A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01

This study has been terminated.

(Sponsor decision - not related to safety)

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

ClinicalTrials.gov Identifier:

NCT00583557

First received: December 20, 2007

Last updated: October 29, 2012

Last verified: October 2012

History of Changes

Results First Received: April 7, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Intervention:	Drug: belimumab

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
Belimumab 10 mg/kg	Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol

Participant Flow: Overall Study

	Belimumab 10 mg/kg
STARTED	155
Received at Least 1 Dose Belimumab	153
COMPLETED	85 ^[1]
NOT COMPLETED	70
Withdrawal by Subject	18
Adverse Event	9
Lack of Efficacy	31
Lack of Compliance	5
Other	5
Did not receive belimumab in LBRA99	2

[1]	Completer defined as subjects whose reason for discontinuation was sponsor discontinuation of study

Baseline Characteristics

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Reporting Groups

	Description
Belimumab 10 mg/kg	No text entered.

Baseline Measures

	Belimumab 10 mg/kg
Number of Participants [units: participants]	153
Age [units: years] Mean ± Standard Deviation	51.1 ± 8.9
Gender [units: participants]
Female	118
Male	35

Outcome Measures

1. Primary:

To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA. [ Time Frame: Up to 5 years ]

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2. Secondary:

The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF). [ Time Frame: up to 5 Years ]

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: For multi-center trials, no investigator will be authorized to publish study results from an individual center until the earlier of the multi-center trial results are published or 12 months after the end or termination of the multi-center trial at all sites. All manuscripts and abstracts must be submitted to the sponsor for review least 30 days prior to submission for publication or for presentation at a scientific meeting. The sponsor may delay publication for up to 3 months.

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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:	NCT00583557 History of Changes
Other Study ID Numbers:	LBRA99
Study First Received:	December 20, 2007
Results First Received:	April 7, 2011
Last Updated:	October 29, 2012
Health Authority:	United States: Food and Drug Administration Poland: Ministry of Health

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