Systemic lupus erythematosus Musculoskeletal Diseases Systemic lupus erythematosus
Conditions
Interventions
Participants are randomised to one of two groups.
Intervention group: Patients will recieve Belimumab according to the standard dosage regime of infusions of 10mg/kg at 2 week interva
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 08/08/2018: 1. Aged between 18 and 75 years 2. Patients with 4 or more criteria for SLE according to the American College of Rheumatology (ACR) 1997 criteria or SLICC 2012 criteria or biopsy proven lupus nephritis with one additional supportive test on at least two occasions (positive ANA, anti-dsDNA antibodies or anti-Sm antibodies) 3. History of anti-dsDNA antibodies detectable at least once in the past 5 years prior to screening the patient on the study protocol (ELISA test is preferable for Anti dsDNA antibody testing) 4. Patients are due to be treated with the first infusion of this cycle of B cell depletion therapy (Rituximab) 4-8 weeks before randomisation (week 0, see participant timeline). Previous use of Rituximab is allowed prior to this cycle. 5. No contraindications to the use of Belimumab 6. Ability to provide informed consent Previous inclusion criteria: 1. Aged between 18 and 75 years 2. Patients with 4 or more criteria for SLE according to the American College of Rheumatology (ACR) 1997 criteria or SLICC 2012 criteria or biopsy proven lupus nephritis with one additional supportive test on at least two occasions (positive ANA, anti-dsDNA antibodies or anti-Sm antibodies) 3. History of anti-dsDNA antibodies detectable at least once in the past taken within one year of screening the patient on the study protocol (ELISA test should be used for Anti dsDNA antibody testing) 4. Patients have received the first infusion of this cycle of B cell depletion therapy (Rituximab) 4-6 weeks before randomisation (week 0, see participant timeline). Previous use of Rituximab is allowed 5. No contraindications to the use of Belimumab 6. Ability to provide informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 08/08/2018: 1. Severe “critical” SLE flare defined as BILAG A flare in CNS system or any SLE manifestation requiring more immunosuppression than allowed within the protocol in the physician's opinion 2. Pregnancy and/or Breast Feeding patients 3. At risk of pregnancy and unwilling to use an acceptable form of birth control contraception (see section 6.3.1.4) 4. Prior use of Belimumab, Atacicept or any biologic therapy (except Rituximab, but no other B cell depleting therapies) 5. Participation in any other interventional trial within the last 6 months 6. eGFR 1 year ago) 15. Severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, pulmonary, cardiac, or neurological disease or, in the investigator’s opinion, any other concomitant medical condition or significant abnormal laboratory value that places the participant at risk by participating in this study with the exception of diseases or conditions related to active SLE 16. Comorbidities currently requiring systemic corticosteroid therapy 17. Evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investiga
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti dsDNA-antibody levels are measured using blood sample testing at week -4 (baseline) and 52 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 26/03/2019: 1. Anti-dsDNA antibody levels at 24 weeks. 2. Proportion of participants with any adverse events by 52 weeks. 3. Proportion of participants with any serious adverse events by 52 weeks. 4. Proportion of participants with any infections by 52 weeks. 5. Proportion of participants with a severe disease flare (defined as one BILAG A or two B flares) by 52 weeks. 6. Proportion of participants with a severe or a moderate disease flare (defined one BILAG B flare accompanied by an increase in concomitant lupus medication - glucocorticoids, Mycophenolate, Azathioprine, or Methotrexate) by 52 weeks. 7. Time to severe disease flare. 8. Proportion of participants with a severe disease flare by 24 weeks. 9. SLEDAI 2000 at 52 weeks. 10. Subject Global Assessment of Disease Activity (SGADA) at 52 weeks. 11. C3 levels at 52 weeks. 12. Immunoglobulin levels at 52 weeks. 13. Cumulative steroid dose from randomisation to 52 weeks. 14. Proportion of participants decreasing steroid dose at randomisation by 50% without experiencing a severe flare, or if below 10mg/day at randomisation reducing dose to 5mg/day or less at 52 weeks. 15. Lupus Quality of Life (Lupus QoL), SF-36 at 52 weeks 16. Average EQ-5D from randomisation to 52 weeks. 17. C-SSRS (Columbian Suicide Severity Rating Scale) to assess suicidality risk at 52 weeks. Previous secondary outcome measures: 1. Anti-dsDNA antibody levels are measured using Blood sample testing at 24 and 68 weeks 2. Proportion of patients with any adverse events is measured by reviewing patient notes, blood sample testing, SLEDAI 2000 questionnaire, SLICC index and BILAG 2004 at week - | — |
Countries
England, United Kingdom
Contacts
Public ContactFelicia Ikeji
Outcome results
None listed