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NCT00071812 · ClinicalTrials.gov registry record · Phase 2

A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)

A Phase 2 study, sponsored by Human Genome Sciences.

Completed
Registry status
Phase 2
Development phase
283
Enrollment target

NCT00071812: Completed Phase 2 study, sponsored by Human Genome Sciences.

NCT00071812 is a Phase 2 study that has completed, run by Human Genome Sciences. The registered enrollment target is 283 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (113% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00071812, a Phase 2 study, has completed, sponsored by Human Genome Sciences.

COMPLETED
Registry status
Phase 2
Development phase
283 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with rheumatoid arthritis (RA).

Primary Outcome

An ACR20 response is defined as having at least a 20% improvement in tender and swollen joints as well as a 20% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate \[ESR\]).

Interventions

  • DRUG Placebo
  • DRUG Belimumab 1 mg/kg
  • DRUG Belimumab 10 mg/kg
  • DRUG Belimumab 4 mg/kg

Trial Details

FieldValue
Enrollment Target 283 participants
Start Date 2003-12
Est. Completion 2005-12
Phase Phase 2
Human Genome Sciences

17 total trials

What the finished NCT00071812 record still lists

NCT00071812 is an interventional study that assigns participants to a tested intervention. The registered 283 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (113% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00071812 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00071812 about?

NCT00071812 is a clinical study titled "A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)". The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with rheumatoid arthritis (RA).

What is the current status of trial NCT00071812?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 283 participants. The study started on 2003-12. Estimated completion is 2005-12.

What interventions are being tested in trial NCT00071812?

The interventions under investigation include: Placebo (DRUG), Belimumab 1 mg/kg (DRUG), Belimumab 10 mg/kg (DRUG), Belimumab 4 mg/kg (DRUG).

Who is sponsoring clinical trial NCT00071812?

This trial is sponsored by Human Genome Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00071812's enrollment target sits among peer trials

283 195th of 2000 higher than 1,806 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00071812, the US trial registry maintained by the National Library of Medicine. NCT00071812 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.