Rituximab Objective Outcome Measures Trial in SLE (ROOTS)

Inclusion Criteria:

• Adults aged at least 18 years old
• Active musculoskeletal SLE defined by inflammatory musculoskeletal pain with either clinical synovitis, ultrasound tenosynovitis or positive power Doppler in at least 1 joint
• No contraindication to the use of IV methylprednisolone, biosimilar rituximab, or any other required medications such as antipyretics and antihistamines
• Willing to use appropriate contraception if at risk of pregnancy
• Disease activity that is refractory to hydroxychoroquine, or patients unable to take hydroxychoroquine due to contra-indication or prior toxicity

Exclusion Criteria:

• • Severe "critical" SLE flare defined as: (i) BILAG 2004 A flare in CNS system; (ii) BILAG 2004 A flare in the renal system; or (iii) any other SLE manifestation requiring more immunosuppression than allowed within the protocol in the physician's opinion

  • Pregnancy
  • Breast Feeding
  • Receipt of daily oral glucocorticoids greater than 10mg prednisolone or equivalent at screening or within the previous 5 days, or change in glucocorticoid dose in the previous 5 days.
  • Receipt of intramuscular or intravenous glucocorticoids within the past 4 weeks
  • Receipt of intravenous immunoglobulin, plasma exchange or cyclophosphamide within the last 3 months
  • Rituximab within the past 18 months or other biologic therapies within the past 6 months
  • Active infections, including but not limited to the human immunodeficiency virus, hepatitis B (including prior infection as judged by positive Hepatitis B core antibody) or hepatitis C
  • Serum IgG below the lower limit of the local laboratory range
  • Receipt of a live attenuated vaccine within 3 months prior to study enrolment
  • History of cancer in the past 5 years except for squamous or basal cell carcinoma that has been completely excised or treated cervical carcinoma in situ
  • In female participants, known history of cervical dysplasia CIN Grade III cervical high-risk human papillomavirus or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS) within the past 3 years. The patient will be eligible after the condition has resolved (e.g., follow-up HPV test is negative or cervical abnormality has been effectively treated >1 year ago)
  • Planned surgery within the study period that is expected to require overnight hospital admission
  • Any other concomitant medical condition that, in the investigator's opinion, or after discussion with the CI, places the participant at risk by participating in this study