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Metabolic, Endocrine

Graves-PCD - Closed

Randomised controlled trial of plasma cell depletion for severe Graves’ disease.

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

Aim: To determine if daratumumab modulates the humoral immune response in Graves’ disease patients

Primary Outcome:

Change in serum TRAb antibodies from baseline to 12 weeks compared to change in placebo group

  • Population: Adult
  • Phase: IIa
  • Design: Adaptive
  • Setting: Secondary care
  • Planned Sample Size: 30

Website:  Graves-PCD

RitPBC - Closed

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

RIGD - Closed

Adjuvant Rituximab: a potential treatment for the young patient with Graves’ hyperthyroidism

  • Study stage: Closed
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: Medical Research Council (MRC)
  • Therapeutic area: Metabolic and Endocrine
  • Type of study: CTIMP (rare disease)

Aim: To establish whether a 500mg dose of Rituximab (RTX), when administered together with a 12 month course of ATD, is likely to result in a meaningful improvement in the proportion of young people with Graves' hyperthyroidism entering disease remission.

Primary outcome:

The number of subjects in remission at 2 years following a single dose of RTX and a 12 month course of ATD is the primary trial endpoint: this is equivalent to the number who have not relapsed. Subjects will be deemed to have relapsed if they are receiving any concomitant anti-thyroid drug medication after visit 10 has occurred (due 52 weeks post RTX administration +/- 14 days), or have undergone surgical (thyroidectomy) or RI treatment because of hyperthyroidism at any time following RTX administration. They will also be deemed to have relapsed if serum TSH is less than the lower limit of the normal laboratory reference range and serum FT3 is above the upper limit of the normal laboratory reference range at 2 years (central biochemical analysis in the Newcastle laboratory for TSH and FT3).

  • Population: Paediatric
  • Phase: IIb
  • Design: Cohort
  • Setting: Secondary care
  • Planned Sample Size: 27

RIGD2 - In Set-up

A randomised controlled trial of adjuvant rituximab in young people with Graves’ disease

  • Study stage: – In set-up
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: NIHR EME Fellowship
  • Therapeutic area: Metabolic and Endocrine
  • Type of study: CTIMP (rare disease)

Aim:

The aim of this clinical trial is to determine whether a single dose of RTX, given in addition to 2 years of daily ATD drug, according to a standard regimen, increases the remission rate in young people with GD.

Primary objective:

To determine if a single dose of RTX, alongside 2 years of standard ATD therapy, results in a clinically significant increase in the proportion of young people with GD who are in disease remission at 36 months (12 months after discontinuing ATD).

  • Population: Children and young adults 12 - 24 years
  • Phase: III
  • Design: RCT single blinded
  • Setting: Secondary Care
  • Planned Sample Size: 124
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