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

Phase 2

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: belimumab

• Registration Number: NCT00583557
• Lead Sponsor: Human Genome Sciences Inc.

Brief Summary

This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.

Detailed Description

This is a multi-center, open label, continuation trial of LymphoStat-B™ in Rheumatoid Arthritis (RA) subjects who achieved at least an ACR20 response in the Phase 2 study LBRA01 (NCT00071812).

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-31
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Results First Submitted: 2011-04-07
• Results First Submitted QC: 2011-06-03
• Results First Posted: 2011-06-29
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

1. Have completed the LBRA01 trial.
2. Have achieved at least an ACR20 response at the end of LBRA01.

Primary

Exclusion Criteria

1. Have switched NSAIDs due to worsening RA disease activity, used more than 10 mg/day of oral prednisone, or were given a corticosteroid injection during the last 30 days of LBRA01.

2. Required a new DMARD (not otherwise excluded in protocol LBRA01) to replace an ineffective one, or an additional DMARD (not to exceed 2 DMARDs in total) within the last 60 days of LBRA01.

3. Used prohibited medications during their participation in LBRA01. These medications include the following:

   • Other investigational agents.
   • Biologic response modifiers
   • Cyclophosphamide.
   • Corticosteroid injections (except 1 injection of up to 40 mg of prednisone into an inflamed joint or intramuscularly every 6 months).
   • 2 new DMARDs.
   • 1 new DMARD plus high dose prednisone >10 mg/day.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Belimumab	belimumab	-

Primary Outcome Measures

Name	Time	Method
To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.	Up to 5 years	SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.

Secondary Outcome Measures

Name	Time	Method
The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).	up to 5 Years	NOT ANALYZED

Trial Locations

Locations (48)

Univ of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Arizona Arthritis Research; 🇺🇸 Paradise Valley, Arizona, United States

Arthritis Health; 🇺🇸 Scottsdale, Arizona, United States

The University of Arizona Health Sciences Center; 🇺🇸 Tucson, Arizona, United States

University of Southern CA; 🇺🇸 Los Angeles, California, United States

Wallace Rheumatic Disease Center; 🇺🇸 Los Angeles, California, United States

Boling Clinical Trials; 🇺🇸 Rancho Cucamonga, California, United States

Arthritis Care Center, Inc.; 🇺🇸 San Jose, California, United States

Arthritis Associates & Osteoporosis Center of Colorado Springs; 🇺🇸 Colorado Springs, Colorado, United States

Washington Hospital Center; 🇺🇸 Washington, DC, District of Columbia, United States

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