NCT00931086

Brief Summary

An expanded access trial of belimumab for named patients who participated in LBRA99.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

2.7 years

First QC Date

June 30, 2009

Last Update Submit

October 29, 2012

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisRA

Interventions

belimumabDRUG

IV 10mg/kg q28days

Also known as: BENLYSTA™ (belimumab), LymphoStat-B™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have in the clinical judgment of the investigator, experienced significant clinical benefit while on belimumab treatment in the HGS Protocol LBRA99.
  • Over the course of the study and for 60 days after the last dose of study agent, any woman with an intact uterus who is not post-menopausal must agree to practice a medically accepted method of contraception.
  • Over the course of the study and for 60 days after the last dose of study agent, all men must agree to practice a medically accepted method of contraception.
  • Have the ability to understand the requirements of this study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the required study visits.

You may not qualify if:

  • Had not been previously treated with belimumab in LBRA99 or were discontinued from treatment prior to HGS' decision to terminate LBRA99.
  • Had clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to RA (ie, cardiovascular, pulmonary, anemia, gastrointestinal, hepatic, renal, neurological, cancer or infectious diseases) that could, in the opinion of the principal investigator, put the patient at undue risk.
  • Are a pregnant female or nursing mother.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology Associates of Central Florida

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

belimumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2009

First Posted

July 2, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

US(1)