---
title: Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99
nct_id: NCT00931086
overall_status: NO_LONGER_AVAILABLE
sponsor: Human Genome Sciences Inc., a GSK Company
study_type: EXPANDED_ACCESS
primary_condition: Rheumatoid Arthritis
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00931086.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00931086"
ct_last_update_post_date: 2012-10-31
last_seen_at: "2026-05-12T07:04:39.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99

**Official Title:** An Expanded Access Trial of Belimumab Antibody (Monoclonal Anti-BLyS Antibody) in Patients With Rheumatoid Arthritis (RA) Who Were Previously Treated Under HGS Protocol LBRA99

**NCT ID:** [NCT00931086](https://clinicaltrials.gov/study/NCT00931086)

## Key Facts

- **Status:** NO_LONGER_AVAILABLE
- **Study Type:** EXPANDED_ACCESS
- **Lead Sponsor:** Human Genome Sciences Inc., a GSK Company
- **Collaborators:** GlaxoSmithKline
- **Conditions:** Rheumatoid Arthritis
- **Start Date:** 2009-04
- **Completion Date:** 2011-12
- **CT.gov Last Update:** 2012-10-31

## Brief Summary

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

## Detailed Description

An expanded access trial of belimumab for named patients with Rheumatoid Arthritis (RA) who have experienced continued benefit under HGS Protocol LBRA99.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Have in the clinical judgment of the investigator, experienced significant clinical benefit while on belimumab treatment in the HGS Protocol LBRA99.
2. 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.
3. 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.
4. 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.

Exclusion Criteria:

1. Had not been previously treated with belimumab in LBRA99 or were discontinued from treatment prior to HGS' decision to terminate LBRA99.
2. 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.
3. Are a pregnant female or nursing mother.
```

## Interventions

- **belimumab** (DRUG) — IV 10mg/kg q28days

## Locations (1)

- Rheumatology Associates of Central Florida, Orlando, Florida, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.rheumatology associates of central florida|orlando|florida|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00931086.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00931086*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*