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Contact Information:

Dr RODEX UK National Coordinator
-
RODEX@cardiff.ac.uk


Dr Charlotte Bradbury
+44 (0)160 63307300
c.bradbury@bristol.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - A clinical study in order to compare the effectiveness and safety of two different treatments in patients with newly diagnosed primary immune thrombocytopenia
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A clinical study in order to compare the effectiveness and safety of two different treatments in patients with newly diagnosed primary immune thrombocytopenia

Recruiting

Open to: All Genders

Age: Mixed

Torquay Birmingham Norwich Oxford Bristol Glasgow Newcastle upon Tyne Plymouth Canterbury

Medical Conditions

Primary immune thrombocytopenia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


RODEX is investigating immune thrombocytopenia (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 the 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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Nov 2023 31 Mar 2025

RODEX will recruit up to 126 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. 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 the study arm.


Adult (≥18 years old) patients recently diagnosed with ITP with a low platelet count and no prior ITP treatment

You can take part if:



You may not be able to take part if:


1. WHO performance status >2. Previous therapy with rituximab (within 3 months previous to study enrollment), corticosteroids or therapy with other immunomodulating agents within 1 month before enrolment; prior use of hematopoietic analogs or fostamatinib for any other reason than ITP three months before enrolment. 3. Previous use of romiplostim, PEG-recombinant human (rHu) megakaryocyte growth and development factor, eltrombopag, recombinant human anti-thrombopoietin (rHuTPO), or any platelet-producing agent for three months prior to enrolment. 4. Alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study. 5. Splenectomy within 3 months of the screening visit or planned splenectomy during the study period. 6. Abnormal renal function (serum creatinine > 1.5 mg/dL). 7. Active hepatic disease evidenced by alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels >5 times the upper limit of normal (it will only be necessary to determine one of the two transaminases). 8. Severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) > 1.4, hypoalbuminemia, portal vein hypertension including the presence of otherwise unexplained splenomegaly and history of esophageal varices. 9. Patients with known IgM seropositive tests for cytomegalovirus and/or Epstein-Barr virus in the previous month. 10. Patients with an active viral infection at screening for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or detectable virus charge of HIV. 11. Intolerance to dexamethasone. 12. History of a bone marrow stem cell disorder. 13. Active or prior malignancy except adequately treated (i.e., complete surgical excision with negative margins) basal cell carcinoma. 14. History of Helicobacter pylori by urea breath test or stool antigen test within 6 months of enrollment, if available. 15. History of myelodysplastic syndrome, systemic lupus erythematosus, or autoimmune cytopenia. 16. History of antiphospholipid antibody syndrome. 17. History of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura. 18. History of deep or superficial venous thromboembolism in the last 12 months or stroke, acute ischaemic heart disease or acute peripheral vascular disease in the last 6 months. 19. Hypersensitivity to any recombinant Escherichia coli-derived product (e.g., Infergen, Neupogen, Somatropin, and Actimmune) or known sensitivity to any of the products to be administered during dosing 20. Currently enrolled in another investigational device or drug study or < 30 days since ending another investigational device or drug studies, or receiving other investigational agents. 21. Will have any other investigational procedures performed while enrolled in this clinical study. 22. Pregnant or breastfeeding, or planning to become pregnant or breastfeed during treatment or within 1 month after the end of treatment. 23. Female subject of childbearing potential is not willing to use, in combination with her partner, an acceptable method of effective contraception during treatment and for 1 month after the end of treatment (see annex 5 for additional contraception information). Females of childbearing potential should only be included after a negative pregnancy test. 24. Will not be available for protocol-required study visits, to the best of the subject’s and investigator’s knowledge. 25. Any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. 26.Other serious comorbidities at investigator criteria.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Torbay and South Devon NHS Foundation Trust
    Torbay Hospital Newton Road
    Torquay
    TQ2 7AA
  • University Hospitals Birmingham NHS Foundation Trust
    Queen Elizabeth Hospital Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
    Colney Lane Colney
    Norwich
    NR4 7UY
  • John Radcliffe Hospital
    Headley Way Headington
    Oxford
    OX3 9DU
  • University Hospitals Bristol and Weston NHS Foundation Trust
    Trust Headquarters Marlborough Street
    Bristol
    BS1 3NU
  • Glasgow Royal Infirmary
    84 Castle Street
    Glasgow
    G4 0SF
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Freeman Hospital Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • University Hospitals Plymouth NHS Trust
    Derriford Hospital Derriford Road Derriford
    Plymouth
    PL6 8DH
  • East Kent Hospitals University NHS Foundation Trust
    Kent & Canterbury Hospital Ethelbert Road
    Canterbury
    CT1 3NG

You will not be paid or receive any incentive for participating in this study. The additional study assessments you receive may help to identify health conditions and care options that would not otherwise be identified through your routine care. However, the study may not benefit you personally. We hope that the research could in the future improve the care and prognosis of other patients with ITP.
The study PIS lists the main risks and burdens of the study, including common side effects of the study drugs and other medications that should not be taken with the study treatment, and other types of risks and burdens associated with the study. The PIS refers the participant to the IMP (romiplostim and dexamethasone) package inserts and treating doctor for further information about drug-related risks and toxicities. The PIS risks and side effects section text is based on information provided in the submitted SPCs, IBs, and Amgen Risks and Discomforts mandated text.
• Hypersensitivity reactions (including rare cases of rash, urticaria and angioedema)
• Headache and dizziness
• Difficulty in sleeping
• Abdominal pain, upset stomach and vomiting
• Pain in extremities (arms and legs), muscles and bones
• Progression of existing Myelodysplastic Syndrome (MDS; A group of disorders resulting from poorly formed or dysfunctional blood cells that cause tiredness, difficulty in breathing, pale skin, frequent infections, easy bruising and bleeding)
• Low platelets (a type of white blood cells that helps fight infections)
• High platelets leading to bleeding
• Increased likelihood of a blood clot
• Increased fibres in the bone marrow
• Difficulty sleeping
• Changes in mood (euphoria most frequent, but also including negative feelings)
• Increased blood sugars
• Stomach irritation and intestinal perforation
• Increased susceptibility to infection and masking of infection symptoms
• Changes in white blood cells (defences) and coagulation
• Hypersensitivity reactions
• Endocrine disorders, such as weight gain
• Cardiovascular disorders (arterial hypertension, bradycardia, deterioration of severe heart failure, and difficulty regulating blood pressure)
These side effects will be minimised via a strict drug dosing and dose reduction schedule and regular toxicity assessment reporting throughout the study treatment period. Participants who have significant side effects will stop treatment but be followed up for safety reasons. Safety events will be monitored regularly in real-time and by oversight groups.
Dexamethasone is known to affect the development of male sperm and the female ovarian cycle. The effects of Romiplostim on sperm and the ovarian cycle are unclear. The ability of either drug to cross the placental barrier between mother and child, and the effects of either drug on the unborn child are unclear. So the drugs are only recommended to be given to pregnant mothers if the benefit outweighs the risks for the mother and child. Participants of childbearing age will have the inconvenience of taking contraception to avoid pregnancy of female participants and female partners of male participants. Participants will be given strict contraception guidance and advised that they should avoid pregnancy. Participants unwilling to use suitable contraception will not be permitted to participate. Individuals who become pregnant during and up to 30 days after the participant stopped study treatment will be asked to provide optional consent for the collection of pregnancy data to support follow-up for safety reasons.
• Taking part will take some time that may not otherwise have been taken, for example, to complete the consent form, attend extra visits for study assessments and blood sample collections, and complete the study questionnaires.
• Blood collection can occasionally be associated with dizziness, hematoma formation, infection at the injection site, needle phobia, and multiple attempts punctures to locate the veins.
• Quality of life questionnaires may include topics and questions that are upsetting to some patients. Patients may choose not to complete individual questions and/or questionnaires. If they are upset by this part of the study they may seek support from their study doctor/nurse who will signpost them to appropriate local resources.
The number of study-specific assessment visits, blood sample collections, and questionnaires has been restricted to the minimum number required to answer the study questions and, thus, reduce the impact of these additional burdens.

Dr Charlotte Bradbury
+44 (0)160 63307300
c.bradbury@bristol.ac.uk


Dr RODEX UK National Coordinator
-
RODEX@cardiff.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI) and funded by Amgen.



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Read full details for Trial ID: ISRCTN10454031

Or CPMS 57733

Last updated 07 March 2025

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