Rheumatoid ArthritisPhase 2NCT00583557

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

A Phase 2 study testing belimumab in people with Rheumatoid Arthritis, run by Human Genome Sciences Inc. at 48 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: belimumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 155 participants
Where: 48 sitesin 2 countries
Study dates: Jan 2005to Nov 2009
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Primary Inclusion Criteria:

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

Primary Exclusion Criteria:

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.
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.
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.

Trial locations and contacts

48 sites in 2 countries.

Country

City, postcode or hospital

48 sites in 2 countries

United States44 sites

The Center for Rheumatology
Albany, New York, 12206
Arthritis Clinic of Northern Virginia, P.C.
Arlington, Virginia, 22205
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Radiant Research Boise
Boise, Idaho, 83704
Arthritis Clinic and Carolina Bone and Joint
Charlotte, North Carolina, 28210
Rheumatology Associates
Chicago, Illinois, 60612
Arthritis Associates & Osteoporosis Center of Colorado Springs
Colorado Springs, Colorado, 80910
The Osteoporosis and Arthritis Clinical Trial Center
Cumberland, Maryland, 21502
Arthritis Centers of Texas
Dallas, Texas, 75246
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8884
Strafford Medical Associates, P.A.
Dover, New Hampshire, 03820
Rheumatic Disease Center
Glendale, Wisconsin, 53217
Houston Institute for Clinical Research
Houston, Texas, 77074
Gundersen Clinic, LTD
La Crosse, Wisconsin, 54610
Arthritis Center of Nebraska
Lincoln, Nebraska, 68506
University of Southern CA
Los Angeles, California, 90033
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
Medical Specialists
Munster, Indiana, 46321
IPC Clinical Research
Ogden, Utah, 84403
Bone and Joint Hospital - Research Department
Oklahoma City, Oklahoma, 73103
Oklahoma Medical Reseach Foundation
Oklahoma City, Oklahoma, 74114
Rheumatology Associates of Central Florida
Orlando, Florida, 32806
Arizona Arthritis Research
Paradise Valley, Arizona, 85253
University of Pittsburgh School of Medicine & ASPH
Pittsburgh, Pennsylvania, 15261
Boling Clinical Trials
Rancho Cucamonga, California, 91730
Mayo Clinic
Rochester, Minnesota, 55905
Arthritis Care Center, Inc.
San Jose, California, 95126
Arthritis Health
Scottsdale, Arizona, 85260
Seattle Arthritis Clinic
Seattle, Washington, 98133
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
The University of Arizona Health Sciences Center
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 Rheumatology and Bone Research
Wheaton, Maryland, 20902
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090
Wake Forest Unviersity School of Medicine
Winston-Salem, North Carolina, 27599-7280
Rheumatology Northwest Clinical Trials
Yakima, Washington, 98902

Other trials in United States

Poland4 sites

NZOZ Centrum Medyczne
Bialystok
Wojewodzki Zespol Reumatologiczny
Sopot
Instytut Reumaologii
Warsaw
Instytut Reumatologii
Warsaw

Other trials in Poland

About this study

Official title: A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) Who Completed the Phase 2 Protocol LBRA01

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.

Read the 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).

Conditions: Rheumatoid Arthritis
Being tested: belimumab
Keywords: Rheumatoid Arthritis, 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.

belimumabDrug
Also called LymphoStat-B™
IV 10mg/kg Q28 days

Study groups in NCT00583557
Study group	Role	What they receive
Belimumab	Experimental	Not described Receives: Drug: belimumab

What is being measured

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

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

Secondary outcomes (1)

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

Timeline

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

Jan 2005Nov 2009

First posted31 Dec 2007 (estimated)
Study startJan 2005
Primary completionNov 2009
Study completionNov 2009

Why it stopped: Sponsor decision - not related to safety

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 155 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00583557
Sponsor's protocol ID: LBRA99
Status last verified: Aug 2013
First submitted: 20 Dec 2007
Last updated: 7 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) Who Completed the Phase 2 Protocol LBRA01
ClinicalTrials.gov ID: NCT00583557
Acronym / sponsor ID: LBRA99
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, RA
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision - not related to safety
Enrolment: 155 participants (actual)
Lead sponsor: Human Genome Sciences Inc.Industry (pharma, biotech, devices)
Study start: Jan 2005
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 31 Dec 2007 (estimated)
Results: Posted 29 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Belimumab	Experimental	Drug: belimumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
belimumabAlso: LymphoStat-B™IV 10mg/kg Q28 days	Drug	Belimumab

Primary outcome

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

1 secondary outcome

The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).
Time frame: up to 5 Years

Results and safety

Results posted to the registry on 29 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Belimumab 10 mg/kg	155	85

Primary outcome: To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.

Time frame: Up to 5 years. Number. Unit: Particpants

Measure	Belimumab 10 mg/kg n = 153
Number of subjects with at least 1 AE	148
Number of subjects with at least 1 Non-Serious AE	144
Number of subjects with at least 1 Serious AE	47
Number of subjects with an AE resulting in death	3

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 5 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Belimumab 10 mg/kg	47 of 153 (30.7%)	144 of 153 (94.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
ClinicalTrials.gov Posting for Parent Protocol LBRA01Link provided by the sponsor.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

48 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing belimumab in people with Rheumatoid Arthritis, run by Human Genome Sciences Inc. at 48 sites in 2 countries.

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: stopped early, as of the sponsor's last update on 7 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 48 sites in United States, Poland. 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. 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 29 Jun 2011). 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?

To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA. (time frame: Up to 5 years). 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 NCT00583557.

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 7 Aug 2013.