Synergetic B-cell Immodulation in SLE (SYNBIoSe)
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|ClinicalTrials.gov Identifier: NCT02284984|
Recruitment Status : Completed
First Posted : November 6, 2014
Last Update Posted : February 28, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Lupus Erythematosus, Systemic||Drug: Rituximab with belimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Synergetic B-cell Immodulation in SLE|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||October 31, 2018|
|Actual Study Completion Date :||October 31, 2018|
Experimental: Rituximab with belimumab
Rituximab 1000mg on day 0 and day 14 Belimumab 10mg/kg on day 28, day 42 and day 56. Thereafter, patients will receive Belimumab 10mg/kg every 4 weeks.
Drug: Rituximab with belimumab
Rituximab treatment on dag 0 and 14, 1000mg iv Belimumab 10mg/kg on day 28, day 42 and day 56. Thereafter, patients will receive Belimumab 10mg/kg every 4 weeks through 72 weeks.
Other Name: Belimumab
- Reduction of pathogenic autoantibodies [ Time Frame: 24 weeks ]A sustained reduction of pathogenic autoantibodies, in particular anti-dsDNA autoantibodies, at 24 weeks after treatment start.
- Seroconversion of pathogenic autoantibodies, in particular anti-dsDNA autoantibodies [ Time Frame: 4, 24, 104 weeks ]
- Safety and feasibility: number of patients with (serious) adverse events [ Time Frame: 4, 24, 104 weeks ]in accordance with the WHO toxicity criteria, including malignancy, suicidal thought/intent/behaviour
- Safety and feasibility: number of patients with infectious events [ Time Frame: 4, 24, 104 weeks ]focused on serious, Varicella-zoster virus (VZV) and opportunistic infections
- Safety and feasibility: number of patients with serious hypersensitivity or infusion reactions [ Time Frame: 4, 24, 104 weeks ]
- Clinical response [ Time Frame: 4, 24, 104 weeks ]
- a reduction in SLEDAI scores, no new BILAG A involvement and the SLE responder index
- in case of lupus nephritis: the number of partial and complete renal responders
- the number of moderate or severe flares and renal flares
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|Ages Eligible for Study:||18 Years to 64 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- age 18 years,
- American College of Rheumatology (ACR) diagnosis of SLE (1997 revised criteria, see appendix 1)
Severe SLE flare at screening (see also section 220.127.116.11.), defined as a situation in which 1 or more of the following criteria are met:
- Increase in SLEDAI (SLE Disease Activity Index) with 12 or more points
- New or worse SLE-related activity of major organs, i.e.: central nervous system (CNS-) SLE (includes NPSLE), vasculitis, nephritis, pericarditis and/or myocarditis, myositis, thrombocytopenia < 60, hemolytic anemia < 4.4mmol/L (=7.0g/dL).
Refractory disease, defined as persisting or progressive disease activity (SLEDAI > 6 points) despite conventional immunosuppressive treatment and 1 or more of the following criteria:
- failure of the initial induction treatment at six months, for which a switch to another induction therapy regime has already been carried out;
- intolerance or contraindication for cyclophosphamide and mycophenolate mofetil (MMF);
- exceeding a cumulative dose of 15 gram of cyclophosphamide;
- a second relapse within two years after start of the initial induction therapy
- a relative contraindication for high-dose oral or intravenous (iv) prednisone, such as avascular osteonecrosis, previous psychosis on corticosteroids, osteoporosis and/or severe obesity (BMI =35 kg/m2).
ANA seropositivity, as defined by a positive ANA-titer = 1:80, before and at screening :
- Positive test results from 2 independent time points within the study screening period; OR
- One positive historical test result and 1 positive result during the screening period. Historical documentation of a positive test of ANA (eg, ANA by HEp-2 titer, ANA by ELISA) must include the date of the test.
Anti-DNA seropositivity, as defined by a positive anti-dsDNA serum antibody = 30 IU/mL, before and at screening:
- Positive test results from 2 independent time points within the study screening period.
- One positive historical test result and 1 positive result during the screening period. Historical documentation of a positive test of anti-dsDNA (eg, anti-dsDNA by Farr assay or ELISA) must include the date of the test.
Immune-complex mediated complement usage, as defined by:
- a low C3 serum level = 0.9 g/L; OR
- a low C4 serum level = 95 mg/L; OR
- a reduced activation of the classical pathway < 75%
- Use of effective contraception
- Active pregnancy, as proven by a positive urine beta-HCG (human chorionic gonadotropin) test or a positive serum beta-HCG
- Significant B-cell depletion (peripheral B-cell counts < 60x10E6)
- Significant hypogammaglobulinemia (IgG < 8.0 g/L)
- Immunization with a live vaccine 1 month before screening
Active infection at time of screening, as follows:
- Hospitalization for treatment of infection within previous 2 months of day 0 of the study
- Use of parenteral (intravenous of intramuscular) antibiotics ( including anti-bacterial, anti-viral, anti-fungal or anti-parasitic agents) within previous 2 months of day 0 of the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284984
|Leiden, Netherlands, 2333 ZA|
|Principal Investigator:||Onno YK Teng, MD, PhD||Leiden University Medical Center|
|Principal Investigator:||A J Rabelink, MD, PhD||Leiden University Medical Center|
|Principal Investigator:||T WJ Huizinga, MD, PhD||Leiden University Medical Center|
|Responsible Party:||YTeng, dr. Y.K.O. Teng, Leiden University Medical Center|
|Other Study ID Numbers:||
|First Posted:||November 6, 2014 Key Record Dates|
|Last Update Posted:||February 28, 2019|
|Last Verified:||February 2019|
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases
Antineoplastic Agents, Immunological
Physiological Effects of Drugs