A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00626197
• Date of registration: 20/02/2008
• Prospective Registration: No
• Primary sponsor: Genentech, Inc.
• Public title: A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG) BELONG
• Scientific title: A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus Erythematosus
• Date of first enrolment: February 2008
• Target sample size: 381
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00626197
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Nephritis

Systemic Lupus Erythematosus

Intervention(s)

Drug: mycophenolate mofetil

Drug: ocrelizumab

Drug: placebo

Drug: corticosteroids

Drug: cyclophosphamide

Primary Outcome(s)

Patients who achieve a partial renal response (PRR) [Time Frame: Week 48]

Patients who achieve a complete renal response (CRR) [Time Frame: Week 48]

Secondary Outcome(s)

Change in SF-36 subscale FACTIT-Fatigue assessment, change from baseline in pain quality, and impact of pain on daily function [Time Frame: Week 48]

Proportion of patients who achieve a reduction from baseline in SLEDAI 2K score, no worsening in physician's global assessment, no new BILAG A organ domain score, and no more than 1 new BILAG B organ domain score [Time Frame: Week 48]

Proportion of patients who achieve a CRR or PRR and who have received a daily dose of corticosteroids from Week 24 and average corticosteroid burden [Time Frame: Week 48]

Proportion of patients who achieve a renal response, major clinical response, or partial clinical response [Time Frame: Weeks 48, 72, and 96]

Secondary ID(s)

ACT4072g

WA20500

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Roche Pharma AG