A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)
Condition: Lupus Nephritis; Systemic Lupus Erythematosus
MeSH terms: Nephritis; Lupus Nephritis; Lupus Erythematosus, Systemic
Intervention: Corticosteroids; Cyclophosphamide; Mycophenolate Mofetil; Ocrelizumab; Placebo; Azathioprine
Intervention description: Intravenous and oral repeating dose; Cyclophosphamide was administered at a IV dose 500 mg every 2 weeks for up to 6 doses followed by maintenance treatment with azathioprine.; Mycophenolate Mofetil was administered orally at maximum dose of 3 g/day.; Ocrelizumab was administed at a dose and as per schedule in arm description; Placebo was administered as per schedule in arm description; Azathioprine was administered at a dose up to 2 mg/kg/day with a maximum dose of 200 mg.
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Azathioprine; Ocrelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 381.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: SLE; Lupus; BELONG

Summary:

      This is a Phase III, randomized, double-blind, placebo-controlled, multicentre,
      parallel-group study designed to evaluate the efficacy and safety of ocrelizumab added to SOC
      (corticosteroid plus one of two immunosuppressant regimens) compared with placebo added to
      SOC in patients with WHO or ISN Class III or IV lupus nephritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 16 years or above at the time of the screening

          -  Ability and willingness to provide written informed consent and to comply with the
             schedule of protocol requirements

          -  Diagnosis of SLE

          -  Active lupus nephritis

        Exclusion Criteria:

          -  Currently active retinitis, poorly controlled seizure disorder, acute confusional
             state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia

          -  Severe renal impairment

          -  Lack of peripheral venous access

          -  Pregnancy or breast feeding mothers

          -  History of severe allergic or anaphylactic reactions to humanized, chimeric or murine
             monoclonal antibodies or i.v. immunoglobulin

          -  Known severe chronic pulmonary disease

          -  Evidence of significant uncontrolled concomitant diseases in any organ system not
             related to SLE, which, in the investigator's opinion, would preclude patient
             participation

          -  Concomitant condition which has required treatment with systemic corticosteroid
             (excluding topical or inhaled steroids) prior to screening

          -  Known HIV or chronic active Hepatitis B or chronic active Hepatitis C infection

          -  Known active infection of any kind prior to Day 1

          -  History of serious recurrent or chronic infection

          -  History of cancer, including solid tumors, hematological malignancies and carcinoma in
             situ (except basal cell carcinoma of the skin that has been excised and cured).

          -  History of alcohol or drug abuse prior to screening

          -  Major surgery prior to screening, excluding diagnostic surgery

          -  Previous treatment with CAMPATH-1H

          -  Previous treatment with a BAFF directed treatment (e.g. anti-BLyS) prior to screening

          -  Previous treatment with a B-cell targeted therapy other than one directed at BAFF
             (e.g. anti-CD20, anti-CD22)

          -  Treatment with any investigational agent prior to screening

          -  Receipt of any live vaccines prior to Day 1

          -  Intolerance or contraindication to oral or i.v. corticosteroids

          -  Positive hepatitis BsAg or hepatitis C serology. Patients who are HBsAg negative but
             HBcAb positive may be enrolled with a negative DNA test