A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus
- Conditions
- -M32 Systemic lupus erythematosusSystemic lupus erythematosusM32
- Registration Number
- PER-117-07
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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 e! Schedule of protocol requirements.
• Diagnosis of SLE according to the current criteria of the American College of Rheumatology (ACR, American College of Rheumatology) (see Appendix 3, page 114). At least 4 criteria must be present, one of which must be a current positive ANA (title of at least 1: 160).
• Active disease in the selection, defined as the presence of ALREADY A BILAG A score in at least one organ system domain other than renal domain OR BiLAG B scores in at least two organ system domains.
• Base use of one of the following immunosuppressants at least 60 days before Day 1 (AZA, 1-3 mg / kg / day, MMF: 1-3 g / day or MTX, 7.5-25 mg / week ) with a maximum change of no more than 50 mg of AZA per day, 500 mg of MMF per day or 5 mg of MTX weekly in the 30 days prior to Day 1.
• 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 AZA, MMF or MTX 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.
• Presence of moderate to severe active glomerulonephritis, as defined by proteinuria> 1g / 24 hours or index urine protein to creatinine in urine (Upr: Ucr)> 1 and the presence of erythrocyte cylinders or> 10 erythrocytes / field (in the absence of infection or menstrual hematuria).
• Currently active retinitis, poorly controlled seizure disorder, acute state of confusion, myelitis, stroke or CVA syndrome, cerebellar ataxia or dementia.
• 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 dyspnea functional ^ Grade 3 on the MRA Scale of Dyspnea).
• Evidence of significant or uncontrolled concomitant diseases in any organ system unrelated to SLE (eg, renal thrombosis, atherosclerotic cardiovascular disease, diabetes mellitus, accelerated hypertension, poorly controlled COPD or asthma, etc.). that at the investigator´s discretion, 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) 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. In addition, any major episode of infection that required hospitalization or treatment with anti- Intravenous infections in the 30 days prior to Day 1 or oral anti-infectives in the 14 days prior to Day 1.
• History of chronic or recurrent serious 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 skin cell carcinoma of the skin that has been excised 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 CAMPATH-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, other than those indicated above, in the 28 days prior to the 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.
• Treatment with a second immunosuppressant or immunomodulator (eg, sulfasalazine, dapsone) in the 8 weeks prior to Day 1 (12 weeks before Day 1 for leflunomide or 4 weeks before Day 1 after 11 days of removal of activated charcoal or standard cholestiramine).
• Prednisone dose 0.7 mg / kg / day (or equivalent) for> 7 of the 30 days prior to selection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method