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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT00626197
Date of registration: 20/02/2008
Prospective Registration: Yes
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
Address: 
Telephone:
Email:
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: corticosteroids
Drug: cyclophosphamide
Drug: mycophenolate mofetil
Drug: ocrelizumab
Drug: placebo
Primary Outcome(s)
Patients who achieve a complete renal response (CRR) [Time Frame: Week 48]
Patients who achieve a partial renal response (PRR) [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 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 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 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
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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