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