RODEX
Research type
Research Study
Full title
A multicentre, randomized, open-label study of romiplostim plus dexamethasone vs dexamethasone in patients with newly diagnosed primary immune thrombocytopenia
IRAS ID
1007244
Contact name
Joanna Smith
Contact email
Sponsor organisation
Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)
Eudract number
2021-006970-22
ISRCTN Number
ISRCTN########
Clinicaltrials.gov Identifier
Research summary
RODEX is investigating Immune Thromobocytopenia (ITP), and an autoimmune disease where the immune system attacks important blood cells called platelets, which are essential for normal clotting. Patients with ITP have reduced numbers of platelets and are at risk of bleeding. A course of corticosteroids (steroids – a man-made version of a hormone the body makes naturally) is recommended as the first line of treatment for adults with newly diagnosed ITP. Most patients with ITP respond to corticosteroids with a rise in platelet count, but improvements are usually temporary and the majority of patients will relapse.
The objective of RODEX is to find out if a two-drug combination of corticosteroids (dexamethasone) plus a medicine called romiplostim is better than dexamethasone alone for first-line of treatment of ITP. Romiplostim is a thrombopoietin-receptor agonist (TPO-RA). Thrombopoietin (TPO) is the natural chemical that the body produces to tell the bone marrow to make more platelets. TPO-RA’s are treatments that act like the body’s own TPO to increase the number of platelets that are produced.
RODEX will recruit up to 126 adult (≥18 years) patients at up to 30 hospital sites in the European Economic Area (EEA), including Spain and Italy, and up to 15 sites and 26+ participants in England, Wales and Scotland, UK. Adult patients will be eligible to take part if they meet the eligibility criteria, including recently diagnosed ITP with a low platelet count and no prior ITP treatment. Participants will be randomly allocated by a computer to receive a course of dexamethasone alone (control arm) or dexamethasone pus romiplostim (investigational arm) and followed up for up to 2 years (screening, day 1, week 8, week 12, month 6, month 12, and end of Study Visit) to find out if dexamethasone plus romiplostim can improve long-term treatment response and avoid bleeding. Study treatments and visits will vary slightly dependent on study arm.
REC name
Wales REC 1
REC reference
23/WA/0199
Date of REC Opinion
1 Sep 2023
REC opinion
Further Information Favourable Opinion