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5-Year lupus drug safety check: benlysta under the microscope

NCT ID NCT01729455

Knowledge-focused Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This 5-year study tracked over 3,000 adults with active lupus to see how safe and effective Benlysta (belimumab) is compared to standard care alone. Researchers monitored serious infections, cancers, and other side effects. The goal was to gather real-world data to help doctors and patients make informed treatment choices.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Belimumab (Benlysta)
What this could lead to
If successful, this study could provide doctors with clearer information on the long-term safety and effectiveness of Benlysta for managing lupus.
What could go wrong
This is an observational registry, not a controlled trial, so results may be influenced by differences between patient groups. It does not test a new treatment, only monitors existing ones.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

3,138 people

The number who actually took part.

Started

Feb 2013

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants with active autoantibody-positive SLE.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males or females age 18 years or older. * Have a clinical diagnosis of active SLE. * Current or history of autoantibody-positive SLE. * Must be treated with SLE therapy including BENLYSTA and/or immunosuppressants (for example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics). * Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures. Exclusion Criteria: * Treatment with an investigational drug within one year of enrollment. Investigational drug applies to any drug not approved for sale in the country it is being used. * Currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or a continuation protocol where belimumab is used as an investigational agent. * Participants who have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA. * Participants only receiving an anti-malarial for SLE. * Participants only receiving steroids for SLE.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

autoimmune disease systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

Contacts and locations

Locations

  • GSK Investigational Site

    Birmingham, Alabama, 35294, United States

  • GSK Investigational Site

    Glendale, Arizona, 85304, United States

  • GSK Investigational Site

    Goodyear, Arizona, 85395, United States

  • GSK Investigational Site

    Phoenix, Arizona, 85032, United States

  • GSK Investigational Site

    Phoenix, Arizona, 85037, United States

  • GSK Investigational Site

    Prescott, Arizona, 86305, United States

  • GSK Investigational Site

    Sun City, Arizona, 85351, United States

  • GSK Investigational Site

    Tucson, Arizona, 85704, United States

  • GSK Investigational Site

    Tucson, Arizona, 85712, United States

  • GSK Investigational Site

    Bakersfield, California, 93301, United States

  • GSK Investigational Site

    La Mesa, California, 92020, United States

  • GSK Investigational Site

    Lakewood, California, 90712, United States

  • GSK Investigational Site

    Loma Linda, California, 92354, United States

  • GSK Investigational Site

    Los Angeles, California, 90033, United States

  • GSK Investigational Site

    Los Angeles, California, 90048, United States

  • GSK Investigational Site

    Los Angeles, California, 90095, United States

  • GSK Investigational Site

    Murrieta, California, 92563, United States

  • GSK Investigational Site

    Pomona, California, 91767, United States

  • GSK Investigational Site

    Upland, California, 91786, United States

  • GSK Investigational Site

    West Hills, California, 91307, United States

  • GSK Investigational Site

    Danbury, Connecticut, 06810, United States

  • GSK Investigational Site

    New Haven, Connecticut, 06520, United States

  • GSK Investigational Site

    Orangeburg, Connecticut, 06518, United States

  • GSK Investigational Site

    Brandon, Florida, 33511, United States

  • GSK Investigational Site

    Clearwater, Florida, 33759, United States

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33309, United States

  • GSK Investigational Site

    Jupiter, Florida, 33458, United States

  • GSK Investigational Site

    Largo, Florida, 33770, United States

  • GSK Investigational Site

    Miami, Florida, 33126, United States

  • GSK Investigational Site

    Miami, Florida, 33136, United States

  • GSK Investigational Site

    Palm Harbor, Florida, 34684, United States

  • GSK Investigational Site

    Pembroke Pines, Florida, 33026, United States

  • GSK Investigational Site

    Pensacola, Florida, 32514, United States

  • GSK Investigational Site

    Plantation, Florida, 33324, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30303, United States

  • GSK Investigational Site

    Gainesville, Georgia, 30501, United States

  • GSK Investigational Site

    Meridian, Idaho, 83642, United States

  • GSK Investigational Site

    Chicago, Illinois, 60611, United States

  • GSK Investigational Site

    Chicago, Illinois, 60612, United States

  • GSK Investigational Site

    Morton Grove, Illinois, 60053, United States

  • GSK Investigational Site

    South Bend, Indiana, 46601, United States

  • GSK Investigational Site

    Baton Rouge, Louisiana, 70809, United States

  • GSK Investigational Site

    Shreveport, Louisiana, 71103, United States

  • GSK Investigational Site

    Baltimore, Maryland, 21286, United States

  • GSK Investigational Site

    Springfield, Massachusetts, 01107, United States

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109-5542, United States

  • GSK Investigational Site

    Ann Arbor, Michigan, 48917, United States

  • GSK Investigational Site

    Detroit, Michigan, 48202, United States

  • GSK Investigational Site

    Eagan, Minnesota, 55121, United States

  • GSK Investigational Site

    Edina, Minnesota, 55435, United States

  • GSK Investigational Site

    Jackson, Mississippi, 39216, United States

  • GSK Investigational Site

    Tupelo, Mississippi, 38801, United States

  • GSK Investigational Site

    St Louis, Missouri, 63110, United States

  • GSK Investigational Site

    St Louis, Missouri, 63117, United States

  • GSK Investigational Site

    St Louis, Missouri, 63132, United States

  • GSK Investigational Site

    Omaha, Nebraska, 68198-7680, United States

  • GSK Investigational Site

    Henderson, Nevada, 89052, United States

  • GSK Investigational Site

    Summit, New Jersey, 07901, United States

  • GSK Investigational Site

    Teaneck, New Jersey, 07666, United States

  • GSK Investigational Site

    Voorhees Township, New Jersey, 08103, United States

  • GSK Investigational Site

    Manhasset, New York, 11030, United States

  • GSK Investigational Site

    Mineola, New York, 11501, United States

  • GSK Investigational Site

    New York, New York, 10016, United States

  • GSK Investigational Site

    New York, New York, 10021, United States

  • GSK Investigational Site

    Roslyn, New York, 11576, United States

  • GSK Investigational Site

    Smithtown, New York, 11787, United States

  • GSK Investigational Site

    The Bronx, New York, 10461, United States

  • GSK Investigational Site

    Charlotte, North Carolina, 28204, United States

  • GSK Investigational Site

    Charlotte, North Carolina, 28207, United States

  • GSK Investigational Site

    Greensboro, North Carolina, 27405, United States

  • GSK Investigational Site

    New Bern, North Carolina, 28562, United States

  • GSK Investigational Site

    Raleigh, North Carolina, 27617, United States

  • GSK Investigational Site

    Rocky Mount, North Carolina, 27804, United States

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27157, United States

  • GSK Investigational Site

    Columbus, Ohio, 43203, United States

  • GSK Investigational Site

    Toledo, Ohio, 43614, United States

  • GSK Investigational Site

    Edmond, Oklahoma, 73013, United States

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103, United States

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104, United States

  • GSK Investigational Site

    Oklahoma City6, Oklahoma, 73103, United States

  • GSK Investigational Site

    Tulsa, Oklahoma, 74104, United States

  • GSK Investigational Site

    Duncansville, Pennsylvania, 16635, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15224, United States

  • GSK Investigational Site

    Charleston, South Carolina, 29406, United States

  • GSK Investigational Site

    Charleston, South Carolina, 29425, United States

  • GSK Investigational Site

    Hixson, Tennessee, 37343-7908, United States

  • GSK Investigational Site

    Nashville, Tennessee, 37203, United States

  • GSK Investigational Site

    Allen, Texas, 75013, United States

  • GSK Investigational Site

    Arlington, Texas, 22205-3606, United States

  • GSK Investigational Site

    Houston, Texas, 77004, United States

  • GSK Investigational Site

    Houston, Texas, 77034, United States

  • GSK Investigational Site

    Nassau Bay, Texas, 77058, United States

  • GSK Investigational Site

    Round Rock, Texas, 78665, United States

  • GSK Investigational Site

    San Marcos, Texas, 78666, United States

  • GSK Investigational Site

    The Woodlands, Texas, 77382, United States

  • GSK Investigational Site

    Danville, Virginia, 24541, United States

  • GSK Investigational Site

    Norfolk, Virginia, 23502, United States

  • GSK Investigational Site

    Roanoke, Virginia, 24016, United States

  • GSK Investigational Site

    Seattle, Washington, 98133, United States

  • GSK Investigational Site

    Glendale, Wisconsin, 91204, United States

  • GSK Investigational Site

    Manitowoc, Wisconsin, 54221-1450, United States

  • GSK Investigational Site

    Buenos Aires, C1280AEB, Argentina

  • GSK Investigational Site

    Ciudad autOnoma de Bueno, C1426AAL, Argentina

  • GSK Investigational Site

    Paraná, 3103, Argentina

  • GSK Investigational Site

    Graz, 8036, Austria

  • GSK Investigational Site

    Linz, 4021, Austria

  • GSK Investigational Site

    Salzburg, A-5020, Austria

  • GSK Investigational Site

    Vienna, A-1100, Austria

  • GSK Investigational Site

    Leuven, 3000, Belgium

  • GSK Investigational Site

    Mississauga, Ontario, L5M 2V8, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5T 2S8, Canada

  • GSK Investigational Site

    Montreal, Quebec, H3G 1A4, Canada

  • GSK Investigational Site

    Québec, Quebec, G1V 2L9, Canada

  • GSK Investigational Site

    Sherbrooke, Quebec, J1G 2E8, Canada

  • GSK Investigational Site

    Bondy, 93140, France

  • GSK Investigational Site

    Lille, 59037, France

  • GSK Investigational Site

    Paris, 75571, France

  • GSK Investigational Site

    Strasbourg, 67098, France

  • GSK Investigational Site

    Bad Bramstedt, 24576, Germany

  • GSK Investigational Site

    Bad Nauheim, 61231, Germany

  • GSK Investigational Site

    Cologne, 51149, Germany

  • GSK Investigational Site

    Dresden, 01067, Germany

  • GSK Investigational Site

    Düsseldorf, 40225, Germany

  • GSK Investigational Site

    Elmshorn, 25335, Germany

  • GSK Investigational Site

    Halle, 06120, Germany

  • GSK Investigational Site

    Hamburg, 22767, Germany

  • GSK Investigational Site

    Heidelberg, 69121, Germany

  • GSK Investigational Site

    Jena, 07740, Germany

  • GSK Investigational Site

    Kiel, 23538, Germany

  • GSK Investigational Site

    Kiel, 24105, Germany

  • GSK Investigational Site

    Leipzig, 04129, Germany

  • GSK Investigational Site

    Mainz, 55131, Germany

  • GSK Investigational Site

    Püttlingen, 66346, Germany

  • GSK Investigational Site

    Stuttgart, 70376, Germany

  • GSK Investigational Site

    Ashkelon, 78278, Israel

  • GSK Investigational Site

    Haifa, 31048, Israel

  • GSK Investigational Site

    Haifa, 31096, Israel

  • GSK Investigational Site

    Jerusalem, 91120, Israel

  • GSK Investigational Site

    Nahariya, 22100, Israel

  • GSK Investigational Site

    Petah Tikva, 49100, Israel

  • GSK Investigational Site

    Ramat Gan, 52621, Israel

  • GSK Investigational Site

    Rehovot, 76100, Israel

  • GSK Investigational Site

    Tel Aviv, 64239, Israel

  • GSK Investigational Site

    Brescia, 25125, Italy

  • GSK Investigational Site

    Milan, 20122, Italy

  • GSK Investigational Site

    Milan, 20132, Italy

  • GSK Investigational Site

    Milan, 20157, Italy

  • GSK Investigational Site

    Padova, 35128, Italy

  • GSK Investigational Site

    Pisa, 56126, Italy

  • GSK Investigational Site

    Roma, 00161, Italy

  • GSK Investigational Site

    Roma, 00168, Italy

  • GSK Investigational Site

    Siena, 53100, Italy

  • GSK Investigational Site

    Udine, 33100, Italy

  • GSK Investigational Site

    Lisbon, 1069-166, Portugal

  • GSK Investigational Site

    Bratislava, 826 06, Slovakia

  • GSK Investigational Site

    Košice, 040 11, Slovakia

  • GSK Investigational Site

    Košice, 97401, Slovakia

  • GSK Investigational Site

    Piešťany, 921 01, Slovakia

  • GSK Investigational Site

    Piešťany, 921 12, Slovakia

  • GSK Investigational Site

    A Coruña, 15006, Spain

  • GSK Investigational Site

    Alicante, 03010, Spain

  • GSK Investigational Site

    BaracaldoVizcaya, 48903, Spain

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Barcelona, 08907, Spain

  • GSK Investigational Site

    Getafe, 28905, Spain

  • GSK Investigational Site

    Las Palmas, 35020, Spain

  • GSK Investigational Site

    Madrid, 28007, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Madrid, 28222, Spain

  • GSK Investigational Site

    Murcia, 30120, Spain

  • GSK Investigational Site

    Santander, 39008, Spain

  • GSK Investigational Site

    Toledo, 45111, Spain

  • GSK Investigational Site

    Valencia, 46017, Spain

  • GSK Investigational Site

    Valencia, 46026, Spain

  • GSK Investigational Site

    Valladolid, 47012, Spain

  • GSK Investigational Site

    VigoPontevedra, 36200, Spain

  • GSK Investigational Site

    Villajoyosa, 3570, Spain

  • GSK Investigational Site

    Stockholm, SE-171 76, Sweden

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