Last updated: 07/17/2024 15:21:25

A Continuation Trial for Subjects with Lupus that Completed Protocol HGS1006-C1056 or HGS1006-C1057

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GSK study ID

112234

See study documents

Clinicaltrials.gov ID

See results summary

EudraCT ID

EU CT Number

Not applicable

Trial status

Completed

Completed

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

Trial overview

Official title: A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects with Systemic Lupus Erythematosus (SLE) who completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057

Trial description: This is a long-term continuation study to provide continuing treatment to subjects with SLE.

Primary purpose:

Treatment

Trial design:

Parallel Assignment

Masking:

None (Open Label)

Allocation:

Non-randomized

Primary outcomes:

Number of participants with Adverse events (AE)

Timeframe: Up to 9 years

AE rates by System Organ Class (SOC) During the Study

Timeframe: Up to 9 years

Number of participants with Serious Adverse events (SAE)

Timeframe: Up to 9 years

SAE rates by SOC During the Study

Timeframe: Up to 9 years

Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points

Timeframe: Baseline and up to 9 years

Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points

Timeframe: Baseline and up to 9 years

Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points

Timeframe: Baseline and up to 9 years

Change From Baseline in Hematocrit at the Indicated Time Points

Timeframe: Baseline and up to 9 years

Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points

Timeframe: Baseline and up to 9 years

Change From Baseline in Calcium (Ca), Carbon dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points

Timeframe: Baseline and up to 9 years

Change From Baseline in Blood urea nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points

Timeframe: Baseline and up to 9 years

Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points

Timeframe: Baseline and up to 9 years

Change From Baseline in BUN and Glucose at the Indicated Time Points

Timeframe: Baseline and up to 9 years

Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points

Timeframe: Baseline and up to 9 years

Change from Baseline in alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) and lactate dehydrogenase (LDH) levels

Timeframe: Baseline and up to 9 years

Change from Baseline in bilirubin (bili) levels

Timeframe: Baseline and up to 9 years

Change from Baseline in immunoglobulin G (IgG) levels

Timeframe: Baseline and up to 9 years

Number of participants with immunogenic response by year

Timeframe: Up to 9 years

Number of participants with IgG values below the lower limit of normal by year

Timeframe: Up to 9 years

Number of participants with shifts from Baseline in Prednisone and other steroids dose by visit

Timeframe: Up to 9 years

Number of participants with any SLICC/ ACR Damage Index worsening (change > 0) from Baseline by visit

Timeframe: Up to 9 years

Secondary outcomes:

Not applicable

Interventions:

Drug: belimumab

Enrollment:

738

Observational study model:

Not applicable

Primary completion date:

2016-09-12

Time perspective:

Not applicable

Clinical publications:

Bruce I, Urowitz M, van Vollenhoven R, Aranow C, Fettiplace J, Oldham M, Wilson B, Molta C, Roth D, Gordon D .Long-term Organ Damage Accrual and Safety in Patients with SLE Treated with Belimumab Plus Standard of Care.Lupus .2016;25(7):699-709.

Ronald F Van Vollenhoven, Sandra V Navarra, Roger A Levy, Mathew Thomas, Amy Heath, Todd Lustine, Anthony Adamkovic, James Fettiplace, Mei-Lun Wang, Beulah Ji, and David Roth.Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension.Rheumatology (Oxford).2019

Ronald F Van Vollenhoven, Sandra V Navarra, Roger A Levy, Mathew Thomas, Amy Heath, Todd Lustine, Anthony Adamkovic, James Fettiplace, Mei-Lun Wang, Beulah Ji, and David Roth.Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension.Rheumatology (Oxford).2020;59(2):281-291 DOI: http://dx.doi.org/10.1093/rheumatology/kez279 PMID: 31302695

Medical condition

Systemic Lupus Erythematosus

Product

belimumab

Collaborators

GSK

Study date(s)

May 2008 to December 2016

Type

Interventional

Phase

3

Participation criteria

Sex

Female & Male

Age

18+ years

Accepts healthy volunteers

No

Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively.

Have developed any other medical disease or condition that has made the patient unsuitable for this study in the opinion of their physician.

Trial location(s)

Location

Status

Contact us

Location

GSK Investigational Site

Bangalore, India, 560034

3.9 miles (6.2 km) away from your location

Status

Study Complete

Study documents

Clinical study report

Available language(s): English

Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status

Completed

Actual primary completion date

2016-09-12

Actual study completion date

2016-09-12

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information

Not applicable

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