Immune-Suppressing Medicines and the Course of Parkinson's Disease
Compares Parkinson's progression in people taking immune-suppressing drugs with those not taking them.
Key facts
- Who runs it
- Medical University of Warsaw
- Where
- Warsaw, PolandSee the site
- Trial code
- Registry title
- Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease
- Status
- Recruiting
- People taking part
- 80 people, planned
- Started
- 1 Mar 2025
- Expected to end
- Sept 2028
- Type of study
- Observational, 2 groups
- Record updated
- 23 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with Parkinson's disease. One group takes long-term immunosuppressive drugs for another illness. The other group has never regularly taken them.
- Sex
- All sexes can join.
- Disease stage
- Parkinson's disease diagnosed by the International Parkinson and Movement Disorder Society criteria.
- Earlier treatment
- Study group: regular immunosuppressive drugs for over 12 months, with a working effect on the illness they treat. Control group: no history of regular immunosuppressive drug use.
Main reasons for not taking part
- Immunosuppressive drugs taken only when symptoms occur, or irregularly
- Immunosuppressive drugs used for less than 12 months
- Advanced cancer, severe heart failure, severe renal failure, untreated autoimmune disease, active inflammation
- Dementia
- Unable to give informed consent
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Diagnosis of Parkinson's disease according to the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease
- Immunosuppressive medication use - medication taken regularly, which we have defined as administered at a dose and frequency effective for the indicated disease, for over 12 months, systemic administration route (oral, intramuscular, subcutaneous, intravenous and inhaled); The most commonly used immunosuppressive drugs that we anticipate will be used by the study group participants include: glucocorticosteroids (GC) - budesonide, cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, triamcinolone; calcineurin inhibitors - tacrolimus, cyclosporine; inosine monophosphate dehydrogenase (IMDH) inhibitors - azathioprine, leflunomide, mycophenolate; mammalian target of rapamycin (mTOR) inhibitors - sirolimus, everolimus; biologics - abatacept, adalimumab, anakinra, certolizumab, etanercept, infliximab, ixekizumab, natalizumab, rituximab, secukinumab, tocilizumab, ustekinumab, vedolizumab; antimetabolites - methotrexate; inclusion of participants taking immunosuppressive drugs not listed above will be considered individually
- Provision of informed consent to participate in the study
- Diagnosis of Parkinson's disease according to the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease
- No history of regular use of immunosuppressive medications
- Provision of informed consent to participate in the study
Who cannot take part
- Use of immunosuppressive drugs for a period of less than 12 months
- Immunosuppressive drug administration at an ad hoc basis (i.e. when symptoms occur) or irregularly (i.e. drug taken at an inappropriate dose and/or with a regularity ineffective for the indicated disease)
- Ineffective treatment of the disease requiring the use of immunosuppressive drugs (no improvement/progression of disease symptoms); Additional exclusion criteria for both the study and control groups:
- Advanced cancer; severe heart failure; severe renal failure; untreated autoimmune disease; active inflammation; diseases that impair drug absorption/metabolism
- Dementia
- Failure/inability to provide informed consent
Where in Poland
- Department of Neurology, Faculty of Health Science, Medical University of WarsawWarsaw, PolandContact: Monika Figura, MD, PhDTaking people
About the trial
What the trial wants to find out
The goal of this observational study is to learn if immunosuppressive drug treatment influences the clinical course of Parkinson's disease. Recent research suggests that Parkinson's disease may have an inflammatory background. Numerous studies have identified elevated levels of pro-inflammatory markers in people with Parkinson's disease. Therefore, immunosuppressive drugs may potentially affect the course of this disease.
Read full original descriptionShow less
The investigators will recruit people with Parkinson's disease, who receive long-term immunosuppressive treatment for other chronic illnesses, into the study group. The study will also recruit people with Parkinson's disease with no history of immunosuppressive drug treatment into the control group. The main question this study aims to answer is:
> Does immunosuppressive drug treatment slow down the onset and/or progression of Parkinson's disease?
Researchers will compare Parkinson's disease progression rates and serum inflammatory marker levels between the study and control group, to see if immunosuppressive drug treatment influences the course of Parkinson's disease.
The study requires each participant to attend one hospital appointment. This appointment will be approximately one hour long, and will involve:
1. clinical Parkinson's disease motor assessments conducted by the research team -> participants will be evaluated in the OFF state, meaning they will not have taken their Parkinson's disease medication the day of the assessment; 2. completion of Parkinson's disease symptom scales; 3. a one-time serum sample collection; 4. detailed medical history obtainment from the participant by the research team, with a primary focus on the patient's immunosuppressive treatment history and individual clinical course of Parkinson's disease.
The 2 groups in the trial
- People with Parkinson's receiving long - term immunosuppressive treatment - study group
- People with Parkinson's without long-term immunosuppressive treatment history - control group
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Analysis of the Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease
- Plain-language title
- Immune-Suppressing Medicines and the Course of Parkinson's DiseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 23 December 2025