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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by GlaxoSmithKline
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT01729455
First received: November 14, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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 Intervention
Systemic Lupus Erythematosus
Biological: BENLYSTA
Other: SLE treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incidence of adverse events of special interest [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    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:
  • Change in organ damage [ Time Frame: Baseline, 6 month intervals up to 5 years ] [ Designated as safety issue: No ]
    Organ damage as assessed by System Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index

  • Change in concomitant SLE medication use [ Time Frame: Baseline, 6 month intervals up to 5 years ] [ Designated as safety issue: No ]
    Concomitant SLE medications including steroids

  • Change in disease activity [ Time Frame: Baseline, 6 month intervals up to 5 years ] [ Designated as safety issue: No ]
    Disease activity as assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2000)

  • Change in severe flares [ Time Frame: Baseline, 6 month intervals up to 5 years ] [ Designated as safety issue: No ]
    Severe flares as derived by a severe flare algorithm.

  • Change in quality of life [ Time Frame: Baseline, 6 month intervals up to 5 years ] [ Designated as safety issue: No ]
    Quality of life as assessed by SF-12v2® Health Survey

  • Change in fatigue [ Time Frame: Baseline, 6 month intervals up to 5 years ] [ Designated as safety issue: No ]
    Fatigue as assessed by FACIT-Fatigue Scale

  • Rate of hospitalizations [ Time Frame: Baseline, 6 month intervals up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: February 2013
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


Detailed Description:

The registry will enroll 2 groups of patients. One group will include patients who are currently taking lupus medicines along with intravenous 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729455

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

  Show 79 Study Locations
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT01729455     History of Changes
Other Study ID Numbers: 116543, HGS1006-C1124
Study First Received: November 14, 2012
Last Updated: July 10, 2014
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
Connective Tissue Diseases
Belimumab
Lupus
Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
SLE
Systemic Lupus Erythematosus
Autoimmune Disease
Antibodies
Immune System Diseases

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014