Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus Registry (SABLE)

• ClinicalTrials.gov Identifier: NCT01729455
• Recruitment Status: Recruiting
• First Posted: November 20, 2012
• Last Update Posted: November 5, 2019
• Sponsor: Human Genome Sciences Inc., a GSK Company
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

Study Description

Brief Summary:

The purpose of this registry is to collect additional information regarding the side effects and effectiveness of BENLYSTA (belimumab) when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). Information will be collected on serious events that are not that common or may only be seen with long-term treatment. These events include death, cancers, serious infections and other infections of interest, and serious mental health problems. Information on the effectiveness of BENLYSTA will also be collected.

Condition or disease	Intervention/treatment
Systemic Lupus Erythematosus	Biological: BENLYSTA; Other: SLE treatment

Detailed Description:

The registry will enroll 2 groups of patients. One group will include patients who are currently taking lupus medicines along with BENLYSTA (With BENLYSTA). The other group will include patients who are taking lupus medicines but do not take BENLYSTA (Without BENLYSTA). For every 3 participants enrolled in the registry, 2 will be taking BENLYSTA and 1 will not. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all patients will continue to be followed regardless of changes in their lupus medicines until study completion. Physicians will manage the patient in accordance with their medical judgment and standard of care. Data will be collected at enrollment and at 6 month intervals for 5 years.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 3000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 12 Years
• Official Title: A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without BENLYSTA™ (Belimumab)
• Actual Study Start Date: February 21, 2013
• Estimated Primary Completion Date: January 31, 2025
• Estimated Study Completion Date: January 31, 2025

Groups and Cohorts

Group/Cohort	Intervention/treatment
With BENLYSTA; SLE treatment including BENLYSTA at baseline	Biological: BENLYSTA; As prescribed. Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus.; Other Name: belimumab; Other: SLE treatment; As prescribed. At baseline, SLE treatment must include an immunosuppressant. During the registry, SLE treatment may include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.
Without BENLYSTA; SLE treatment without BENLYSTA at baseline	Other: SLE treatment; As prescribed. At baseline, SLE treatment must include an immunosuppressant. During the registry, SLE treatment may include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.

Outcome Measures

Primary Outcome Measures :

1. Incidence of adverse events of special interest [ Time Frame: Up to 5 years ]
   Summary of the number and percentage of participants with adverse events within 6 prespecified categories: malignancies (excluding non-melanoma skin cancers), non-melanoma skin cancers, mortality, serious infections, opportunistic infections and other infections of interest, and serious psychiatric events.

Secondary Outcome Measures :

1. Change in organ damage [ Time Frame: Baseline, 6 month intervals up to 5 years ]
   Organ damage as assessed by System Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
2. Change in concomitant SLE medication use [ Time Frame: Baseline, 6 month intervals up to 5 years ]
   Concomitant SLE medications including steroids
3. Change in disease activity [ Time Frame: Baseline, 6 month intervals up to 5 years ]
   Disease activity as assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2000)
4. Change in severe flares [ Time Frame: Baseline, 6 month intervals up to 5 years ]
   Severe flares as derived by a severe flare algorithm.
5. Change in quality of life [ Time Frame: Baseline, 6 month intervals up to 5 years ]
   Quality of life as assessed by SF-12v2® Health Survey
6. Change in fatigue [ Time Frame: Baseline, 6 month intervals up to 5 years ]
   Fatigue as assessed by FACIT-Fatigue Scale
7. Rate of hospitalizations [ Time Frame: Baseline, 6 month intervals up to 5 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

General population: patients with active autoantibody-positive SLE.

Criteria

Key Inclusion Criteria:

• Clinical diagnosis of active SLE.
• Autoantibody-positive.
• Current SLE treatment includes BENLYSTA and/or immunosuppressants (for example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics).

Key Exclusion Criteria:

• Have received treatment with an investigational agent within the past year.
• Are currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or a continuation trial in which belimumab is used as an investigational agent.
• Have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA.
• Current SLE treatment includes only an antimalarial (for example, hydroxychloroquine) or only steroids.

Contacts and Locations

Contacts

Contact: US GSK Clinical Trials Call Center; 877-379-3718; GSKClinicalSupportHD@gsk.com

Contact: EU GSK Clinical Trials Call Center; +44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

  Show 176 Study Locations

Sponsors and Collaborators

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

• Responsible Party: Human Genome Sciences Inc., a GSK Company
• ClinicalTrials.gov Identifier: NCT01729455 History of Changes
• Other Study ID Numbers: 116543; HGS1006-C1124 ( Other Identifier: Human Genome Sciences Inc. )
• First Posted: November 20, 2012
• Last Update Posted: November 5, 2019
• Last Verified: November 2019

Keywords provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):

• Autoimmune Diseases; Autoimmune Disease; Belimumab; Connective Tissue Diseases; Lupus; Additional relevant MeSH terms: Lupus Erythematosus, Systemic; SLE; Systemic Lupus Erythematosus; Antibodies; Immune System Diseases

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Belimumab; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs