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Arthritis, RheumatoidPhase 2NCT00071812

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

A Phase 2 study testing Belimumab 1 mg/kg, Belimumab 4 mg/kg and Belimumab 10 mg/kg in people with Arthritis, Rheumatoid, run by Human Genome Sciences Inc. at 63 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Belimumab 1 mg/kg, Belimumab 4 mg/kg and Belimumab 10 mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
283 participants
Where
63 sitesUnited States
Study dates
Dec 2003to Dec 2005
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Primary Inclusion Criteria:

  • Diagnosis of RA for at least 1 year
  • Failed at least 1 disease modifying anti-rheumatic drug (DMARD) due to toxicity or lack of efficacy. These drugs must include 1 or more of the following: methotrexate, parenteral gold, sulfasalazine, leflunomide, and tumor necrosis factor-alpha (TNFα) inhibitors (infliximab, etanercept or adalimumab)
  • Active RA disease of at least moderate disease activity
  • Be on a stable RA treatment regimen for at least the past 60 days (for DMARDS); if on non-steroidal anti-inflammatory drugs (NSAIDs) or steroids these must be at a stable dose for the last 30 days

Primary Exclusion Criteria:

  • Received a non-FDA approved investigational agent within the last 28 days
  • Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab) or interleukin-1 receptor antagonist (anakinra)
  • Currently receiving or received within the last 6 months the following: anti-CD20 antibody (rituximab) or cyclophosphamide
  • Steroid injection into any joint within the last 30 days
  • History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency
  • History of chronic infection that has been active within last 6 months, or herpes zoster within last 90 days, or any infection requiring hospitalization or intravenous medication within last 60 days
  • Human immunodeficiency virus (HIV), Hepatitis-B, Hepatitis-C

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

United States63 sites

  • The Center For Rheumatology

    Albany, New York, 12206

  • The University of Michigan Health System

    Ann Arbor, Michigan, 48109-0358

  • Arthritis Clinic of Northern Virginia, P.C.

    Arlington, Virginia, 22205

  • Arthritis and Rheumatic Disease Specialties

    Aventura, Florida, 33180

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Ochsner Clinic Foundation

    Baton Rouge, Louisiana, 70809

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-0006

  • Radiant Research Boise

    Boise, Idaho, 83704

  • Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • SUNY-Downstate Medical Center

    Brooklyn, New York, 11203

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7280

  • Arthritis Clinic and Carolina Bone and Joint

    Charlotte, North Carolina, 28210

  • Northwestern University Medical School

    Chicago, Illinois, 60611

  • Rheumatology Associates

    Chicago, Illinois, 60612

  • Arthritis Associates & Osteoporosis Center Of Colorado Springs

    Colorado Springs, Colorado, 80910

  • Arthritis and Osteoporosis Center

    Concord, New Hampshire, 03301

  • The Osteoporosis and Arthritis Clinical Trial Center

    Cumberland, Maryland, 21502

  • Arthritis Centers of Texas

    Dallas, Texas, 75246

  • Research Associates of North Texas

    Dallas, Texas, 75246

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-8884

  • Stat Research, Inc.

    Dayton, Ohio, 45402

  • Strafford Medical Associates, P.A.

    Dover, New Hampshire, 03820

  • Edmonds Rheumatology Associates

    Edmonds, Washington, 98026-8047

  • Evergreen Clinical Reserach

    Edmonds, Washington, 98026-8047

  • Rheumatic Disease Center

    Glendale, Wisconsin, 53217

  • Houston Institute for Clinical Research

    Houston, Texas, 77074

  • Institute of Arthritis and Research

    Idaho Falls, Idaho, 83404

  • Gundersen Clinic, Ltd.

    La Crosse, Wisconsin, 54610

  • Scripps Clinic

    La Jolla, California, 92037

  • Arthritis Center of Nebraska

    Lincoln, Nebraska, 68506

  • University of Southern California

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Wallace Rheumatic Disease Center

    Los Angeles, California, 90048

  • Kentuckiana Center for Better Bone and Joint Health

    Louisville, Kentucky, 40202

  • North Shore University Hospital

    Manhasset, New York, 11030

  • The Medical College of Wisconsin , Inc

    Milwaukee, Wisconsin, 53226

  • Arthritis and Rheumatic Diseases Clinic

    Morgan, Utah, 84403

  • Medical Specialists

    Munster, Indiana, 46321

  • McBride Clinic

    Oklahoma City, Oklahoma, 73101

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

  • Rheumatology Associates of Central Florida

    Orlando, Florida, 32806

  • Stanford University School of Medicine

    Palo Alto, California, 94304

  • Arizona Arthritis Research

    Paradise Valley, Arizona, 85253

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh School of Medicine & ASPH

    Pittsburgh, Pennsylvania, 15261

  • Boling Clinical Trials

    Rancho Cucamonga, California, 91730

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Rockford Clinic

    Rockford, Illinois, 61103

  • UCDMC

    Sacramento, California, 95817-1418

  • Arthritis Care Center, Inc.

    San Jose, California, 95126-1650

  • Arthritis Northwest Rheumatology

    Spokane, Washington, 99204

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Texas Research Center

    Sugar Land, Texas, 77479

  • Tampa Medical Group, P.A.

    Tampa, Florida, 33614

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • University of Arizona

    Tucson, Arizona, 85724

  • Oklahoma Center For Arthritis Therapy & Research

    Tulsa, Oklahoma, 74114

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Marshfield Medical Research Foundation

    Wausau, Wisconsin, 54401

  • Center for Rhematology and Bone Research

    Wheaton, Maryland, 20902

  • Rheumatic Disease Associates

    Willow Grove, Pennsylvania, 19090

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

  • Rheumatology Northwest Clinical Trials

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (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).

Read the detailed description

The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with RA. All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 24 weeks. Patients completing the 24-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.

Being tested
Placebo, Belimumab 1 mg/kg, Belimumab 4 mg/kg, Belimumab 10 mg/kg
Keywords
RA
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo IV plus standard therapy (SOC) for RA; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.

  • Belimumab 1 mg/kgDrug

    Also called LymphoStat-B®, BENLYSTA®

    Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.

  • Belimumab 4 mg/kgDrug

    Also called LymphoStat-B®, BENLYSTA®

    Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.

  • Belimumab 10 mg/kgDrug

    Also called LymphoStat-B®, BENLYSTA®

    Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on the same dose of belimumab (10 mg/kg) for an additional 24 weeks.

Study groups in NCT00071812
Study groupRoleWhat they receive
Placebo plus SOCPlacebo comparatorNot described
Receives: Drug: Placebo
Belimumab 1 mg/kg plus SOCExperimentalNot described
Receives: Drug: Belimumab 1 mg/kg
Belimumab 4 mg/kg plus SOCExperimentalNot described
Receives: Drug: Belimumab 4 mg/kg
Belimumab 10 mg/kg plus SOCExperimentalNot described
Receives: Drug: Belimumab 10 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR)

    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]).

    Measured: Baseline, 24 weeks

Secondary outcomes (8)

  1. Percentage of Patients With an ACR50 Response at Week 24, Based on ESR

    An ACR50 response is defined as having at least a 50% improvement in tender and swollen joints as well as a 50% 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]).

    Measured: Baseline, 24 weeks

  2. Percentage of Patients With an ACR70 Response at Week 24, Based on ESR

    An ACR70 response is defined as having at least a 70% improvement in tender and swollen joints as well as a 70% 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]).

    Measured: Baseline, 24 weeks

  3. Time to First ACR20 Response, Based on ESR

    The time to first ACR20 response (based on ESR) is defined as the time from the first dose to the first visit at which a patient first exhibited an ACR20 response, which may or may not have been sustained through Week 24.

    Measured: 0 to 24 weeks

  4. Time to First ACR50 Response, Based on ESR

    Measure not posted because time to ACR50 response was unable to be determined due to the small number of patients achieving an ACR50 response in the study.

    Measured: 0 to 24 weeks

  5. Time to First ACR70 Response, Based on ESR

    Measure not posted because time to ACR70 response was unable to be determined due to the small number of patients achieving an ACR70 response in the study.

    Measured: 0 to 24 weeks

  6. Mean Change in Disease Activity Score 28 (DAS28) at Week 24

    DAS is a composite index of a patient's level of RA disease activity. DAS28 is an abbreviated version of DAS, using a subset of 28 joints in the assessment, calculated based on 4 variables: 1) number of tender joints out of a total of 28 joints, 2) number of swollen joints out of a total of 28 joints, 3) ESR, 4) patient's global assessment of disease activity based on a 100-mm visual analog scale. The calculation provides a number on a scale from 0 to 10 (>5.1=active disease; <3.2=well controlled disease; <2.6=remission). Change from baseline >1.2 = good response and ≤0.6 = non-response.

    Measured: Baseline, 24 weeks

  7. Time to First DAS28 Response

    DAS28 response is defined as the time from the first dose to the first time at which a patient exhibited a "good" or a "moderate" improvement in RA disease activity, based on DAS28 improvements compared to baseline. Good response was defined as >1.2 change from baseline and DAS28 score ≤ 3.2. No response was defined as ≤ 0.6 change from baseline in DAS28 score or change between ≤ 1.2 and > 0.6 with a DAS28 score of > 5.1.

    Measured: 0 to 24 weeks

  8. Mean Change in Modified Total Sharp Score at Week 24

    The modified total Sharp score method was used to evaluate radiographs of hands/wrists for erosions (ERO) and joint space narrowing (JSN). The total modified Sharp score ranges from 0 (no radiographic damage) to 200 (worst possible radiographic damage) and is the sum of the normalized ERO score (range 0-100) and the normalized JSN score (range 0-100). Higher scores indicated more damage.

    Measured: Baseline, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2003 (estimated)
  2. Study startDec 2003
  3. Primary completionJan 2005
  4. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
283 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00071812
Sponsor's protocol ID
LBRA01
Status last verified
Aug 2013
First submitted
31 Oct 2003
Last updated
14 Aug 2013
Data monitoring committee
Yes

Publications

  • Stohl W, Merrill JT, McKay JD, Lisse JR, Zhong ZJ, Freimuth WW, Genovese MC. Efficacy and safety of belimumab in patients with rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled, dose-ranging Study. J Rheumatol. 2013 May;40(5):579-89. doi: 10.3899/jrheum.120886. Epub 2013 Apr 1.

    PubMed 23547209

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Belimumab 1 mg/kg, Belimumab 4 mg/kg and Belimumab 10 mg/kg in people with Arthritis, Rheumatoid, run by Human Genome Sciences Inc. at 63 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR) (time frame: Baseline, 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00071812, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2013.

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