A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG) BELONG
- Conditions
- -M32 Systemic lupus erythematosusSystemic lupus erythematosusM32
- Registration Number
- PER-118-07
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 10
• 16 years of age or older at the time of selection.
• Ability and willingness to provide written informed consent (or obtain the consent of a family tutor, when appropriate) and comply with the schedule of protocol requirements.
• Diagnosis of SLE according to the ACR criteria (see Appendix 4). At least 4 criteria must have been present for the diagnosis of SLE. It is not necessary that the 4 criteria are present at the time of selection.
• Active lupus nephritis defined as follows: NL Class III or IV [exclusive III (C), IV-S (C) and IV-G (C)] according to WHO or ISN confirmed by biopsy (within 6 months prior to randomization). Patients may present Class V (see Table 1) coexisting. When possible, biopsies should be classified and reported according to the ISN / RPS classification scheme. And presence of: protein index in urine to creatinine in urine (Upr: Ucr)> 1 (which should not have improved 50% in the previous 6 months).
• Patients with reproductive potential (men and women) should use a reliable contraceptive method during the study (eg, hormonal contraceptive, intrauterine device, barrier method) according to local regulations and the recommendations of the attending physician. The relevant section of the product information of CYC, MMF or AZA must be respected (as applicable).
• Women with a capacity to procreate must present a negative serum pregnancy test at the screening visit prior to enrollment on Day 1.
• Currently active retinitis, poorly controlled seizure disorder, acute state of confusion, myelitis, stroke or CVA syndrome, cerebellar ataxia or dementia.
• Severe renal insufficiency, defined by the calculated IFG (by Cockroft-Gault) <25 mUmin, or presence of oliguria (defined as documented urine volume <400 mL / 24 hs) or renal biopsy results that indicate chronic irreversible renal scarring ( either> 50% of glomeruli with sclerosis or> 50% interstitial fibrosis in the renal biopsy).
• Absence of peripheral venous access.
• Pregnancy or nursing mothers.
• History of severe anaphylactic or allergic reactions to humanized, chimeric or murine monoclonal antibodies or immunoglobulin i.v.
• Known severe chronic lung disease (FEV1 <50% of predicted or functional dyspnea. Grade 3 on the MRC Dyspnea Scale).
• Evidence of significant uncontrolled comorbidities in any organ system unrelated to SLE (eg, renal thrombosis, atherosclerotic cardiovascular disease, diabetes mellitus, accelerated hypertension, poorly controlled COPD or asthma, etc.), which, at the discretion of the investigator , would impede the patient´s participation.
• Concomitant disease (eg, asthma, Crohn´s disease, etc.) that has required treatment with systemic corticosteroids (except topical or inhaled steroids) at any time in the 52 weeks prior to screening.
• Infection known to be HIV or chronic active hepatitis B or active chronic hepatitis C.
• Known active infection of any type (exclusive fungal infection of nail beds or oral candidiasis that has resolved before Day 1) within 30 days prior to Day 1. In addition, any major episode of infection that required hospitalization or anti-inflammatory treatment -intravenous infections in the 30 days prior to Day 1 or oral anti-infectives in the 14 days prior to Day 1.
• History of serious chronic or recurrent infection. A chest x-ray will be done during the screening, if it was not done in the 12 weeks before the screening, to evaluate the infection. If there is evidence of lung infection, a chest x-ray should be done.
• History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ (except basal cell carcinoma of the skin that has been removed and cured).
• History of alcohol or drug abuse in the 52 weeks prior to selection.
• Major surgery in the 4 weeks prior to selection, except for diagnostic surgery.
• Previous treatment with GAMPATH-1H.
• Prior treatment with a treatment directed to BAFF (eg, anti-BLyS) in the 12 months prior to selection.
• Previous treatment with a therapy directed to B cells, different from that directed to BAFF (eg, anti-CD20, anti-CD22).
• Treatment with any agent under investigation in the 28 days prior to selection or the five half-lives of the investigational drug (whichever is longer).
• Application of any vaccine to live virus in the 6 weeks prior to Day 1 (it is recommended to carefully evaluate the patient´s immunization record and the need for immunization before receiving ocrelizumab).
• Intolerance or contraindication to oral corticosteroids or i.v. 21. Treatment with more than 1 g of OYO (cumulative dose) in the 6 months prior to the selection period.
• Having received more than 2 g of methylprednisolone I.v. (cumulative dose) within 28 days prior to selection.
• Have received doses of oral prednisone> 20 mg / day for more than 14 days before selection. During the 14 days p
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method