Study: NCT03949855

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Belimumab
Description: Belimumab is a recombinant, human, IgG1λ monoclonal antibody.~Belimumab will be provided as a 200 mg sterile, liquid product in a prefilled syringe. Each syringe contains 1.0 mL of 200 mg/mL belimumab. Each syringe will be a single use.~Standard Weekly dose:~Part A: 200 mg. administered subcutaneously. Part B: 400 mg (two 200 mg injections) from weeks 0-3, and then 200 mg from weeks 4-51, administered subcutaneously.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Belimumab
Description: Belimumab is a recombinant, human, IgG1λ monoclonal antibody.~Belimumab will be provided as a 200 mg sterile, liquid product in a prefilled syringe. Each syringe contains 1.0 mL of 200 mg/mL belimumab. Each syringe will be a single use.~Standard Weekly dose:~Part A: 200 mg. administered subcutaneously. Part B: 400 mg (two 200 mg injections) from weeks 0-3, and then 200 mg from weeks 4-51, administered subcutaneously.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Belimumab
Description: Belimumab is a recombinant, human, IgG1λ monoclonal antibody.~Belimumab will be provided as a 200 mg sterile, liquid product in a prefilled syringe. Each syringe contains 1.0 mL of 200 mg/mL belimumab. Each syringe will be a single use.~Standard Weekly dose:~Part A: 200 mg. administered subcutaneously. Part B: 400 mg (two 200 mg injections) from weeks 0-3, and then 200 mg from weeks 4-51, administered subcutaneously.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo for Belimumab
Description: The placebo control will be provided as a sterile liquid product in a prefilled syringe. Each syringe will be of a single use.~Standard weekly dose:~Part A: 200 mg. administered subcutaneously. Part B: 400 mg (two 200 mg injections) from weeks 0-3, and then 200 mg from weeks 4-51, administered subcutaneously.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Rituximab is a monoclonal antibody with specificity for CD20, a transmembrane protein expressed on B cells from the pre-B to memory cell development stages.~Rituximab is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-use vials for infusion. It is a clear, colorless liquid.~Dose: 1000 mg intravenously (IV), Week 4 and -6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Rituximab is a monoclonal antibody with specificity for CD20, a transmembrane protein expressed on B cells from the pre-B to memory cell development stages.~Rituximab is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-use vials for infusion. It is a clear, colorless liquid.~Dose: 1000 mg intravenously (IV), Week 4 and -6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Rituximab is a monoclonal antibody with specificity for CD20, a transmembrane protein expressed on B cells from the pre-B to memory cell development stages.~Rituximab is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-use vials for infusion. It is a clear, colorless liquid.~Dose: 1000 mg intravenously (IV), Week 4 and -6.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Rituximab
Description: Rituximab is a monoclonal antibody with specificity for CD20, a transmembrane protein expressed on B cells from the pre-B to memory cell development stages.~Rituximab is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-use vials for infusion. It is a clear, colorless liquid.~Dose: 1000 mg intravenously (IV), Week 4 and -6.