Newcastle Clinical Trials Unit



B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis

  • Study stage: Closed
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: MRC and NIHR EME
  • Therapeutic area: Metabolic and Endocrine
  • Type of study: CTIMP

Aim: To compare the efficacy of B-cell depleting therapy in Primary Biliary Cirrhosis patients over 12 months

Primary Outcome:

Fatigue severity in PBC patients assessed using the fatigue domain score of the PBC-40, a fully validated, psychometrically robust, disease specific quality of life measure (PBC-40 fatigue domain score >33 at study outset)

  • Population: Adult
  • Phase: II
  • Design: RCT (double blinded)
  • Setting: Primary care
  • Planned Sample Size: 58