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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Tim
Hardy
+44 113 3924396
T.Hardy@leeds.ac.uk
Prof
Paul
Emery
+44 113 392 ext 4884
P.Emery@leeds.ac.uk
Dr
Kulveer
Mankia
+44 113 392 ext 4884
K.S.Mankia@leeds.ac.uk
Inflammatory arthritis
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.
This trial is an open-label randomised control trial (RCT) comparing the effect of the investigational medicinal product Baricitinib versus standard care in a population of individuals at moderate to high risk of developing inflammatory arthritis (IA). Such individuals can be identified by the presence of CCP antibodies in the blood and other clinical features. At present, there are no effective treatments in this pathway until individuals’ develop IA, which is associated with inflammation, swelling, long-term joint pain and disability. Baricitinib may be effective at preventing the development of IA by inhibiting specific enzymes involved in the development of the disease.
The purpose of this trial is therefore to understand if baricitinib can delay the onset of IA in individuals who are deemed to be at-risk of developing IA.
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:
You can take part if:
You may not be able to take part if:
1. Previous diagnosis of RA or other form of inflammatory arthritis including, but not limited to SLE, psoriatic arthritis, ankylosing spondylitis, gout or pyrophosphate arthropathy and including current treatment with DMARDs or biological therapy, or a history of DMARD or biological therapy that in the opinion of the investigator constitutes a therapeutic dose2. Clinical synovitis on clinical examination by a rheumatologist 3. Palindromic rheumatism4. Individuals who are largely or wholly incapacitated permitting little or no self-care, such as being bedridden or confined to wheelchair5. Presence of concomitant illness likely to require systemic steroid therapy during the study, in the opinion of the investigator6. Co-morbidities requiring chronic treatment with immunosuppressive or immune modulating therapy7. Treatment with an oral, intravenous, intramuscular, intrabursal or intraarticular corticosteroid within 12 weeks prior to randomization8. Have had any major surgery within 12 weeks prior to screening or will require major surgery during the study that, in the opinion of the investigator, would pose an unacceptable risk to the screenee9. Scheduled for or anticipating joint replacement surgery10. History of acute allergic reactions to biologic therapies or immunoglobulins11. Have experienced any of the following within 12 weeks of screening: myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure12. Uncontrolled hypertension (≥160/95 mmHg), uncontrolled diabetes, cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia, or any other cardiovascular condition in the past 24 weeks prior to Screening, which, in the opinion of the investigator, would put the screenee at risk by participating in the study13. Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data14. Have a history of lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years15. Have a current or recent (<4 weeks prior to baseline) viral, bacterial, fungal, or parasitic infection that is clinically serious in the opinion of the investigator16. History of disseminated Staphylococcus aureus infection17. History of invasive or opportunistic infection (e.g. listeriosis, pneumocystis or histoplasmosis) or immunodeficiency syndrome18. Have symptomatic herpes simplex or have had symptomatic herpes zoster infection within 12 weeks prior to baseline19. Have a history of disseminated/complicated herpes zoster (for example, multidermatomal involvement, ophthalmic zoster, CNS involvement, or post-herpetic neuralgia)20. Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, herpes zoster and atypical mycobacteria)21. Screenees who are ≥50 years old will be advised to have herpes zoster vaccination. Vaccination must occur >4 weeks prior to baseline. Screenees will be excluded if they are exposed to herpes zoster vaccination within 4 weeks of planned baseline.22. In the opinion of the investigator, are at an unacceptable risk for participating in the study23. Positive test for hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)24. Screenees with tuberculosis (TB), including those at high risk of TB25. Women with positive urine pregnancy test within 48 h prior to start of investigational product. Women of childbearing potential are defined as women who have had any menstrual bleeding in the last 24 months and who have not had a hysterectomy or surgical sterilisation.26. Mothers who are breast feeding 27. Female screenees with reproductive potential unwilling to use an acceptable method of contraception to avoid pregnancy during treatment and for at least 4 weeks after the last dose of trial medication, in the event that they are randomised to the treatment arm28. Male screenees with a female partner of reproductive potential unwilling to use an acceptable form of contraception during treatment and for at least 4 weeks after the final dose of trial medication, in the event that they are randomised to the treatment arm29. Have donated more than a single unit of blood within 4 weeks prior to screening or intend to donate blood during the course of the study30. History of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within the 2 years prior to screening31. Have previously been in another study investigating baricitinib32. Unable or unwilling to make themselves available for the duration of the study and/or unwilling to follow study restrictions/procedures33. Currently enrolled in, or discontinued within 4 weeks prior to screening from any other clinical trial involving an investigational product or non-approved use of a drug or device or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study34. Are investigator site personnel directly affiliated with this study and/or are their immediate families. Immediate family is defined as spouse, parent, child, or sibling, whether biological or legally adopted35. Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator, are clinically significant and indicate an unacceptable risk for the screenee’s participation in the study36. Have been exposed to a live vaccine within 12 weeks of the anticipated first dose of study medication or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination)37. Have screening laboratory test values, including thyroid-stimulating hormone (TSH; where clinically indicated), outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the screenee’s participation in the study. TSH is routinely reviewed in patients that have received stable thyroxine replacement therapy for ≥12 weeks. This investigation and any subsequent management will be in accordance with routine clinical care and outside the context of this trial.38. Have a hypersensitivity to the active substance or any of the excipients listed in section 6.1 of the current, approved, Summary of Product Characteristics for baricitinib39. Have any of the following specific abnormalities on screening laboratory tests: 39.1. Haemoglobin <8·5 g/dl International System of Units [SI]: <85 g/l39.2. White blood cells <3·0 × 103 cells/mm3 (SI: <3·0 × 109 cells/l)39.3. Neutrophils <1·5 × 103 cells/mm3 (SI: <1·5 × 109 cells/l)39.4. Lymphocytes <0·5 × 103 cells/mm3 (SI: <0·5 × 109 cells/l)39.5. Platelets <100 × 103 cells/mm3 (SI: <100 × 109 cells/l)39.6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 × ULN39.7. Total bilirubin level ≥2 × ULN, unless the screenee has been diagnosed with Gilbert’s disease and this is clearly documented39.8. eGFR of <40 ml/min/1.73 m2
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Tim
Hardy
+44 113 3924396
T.Hardy@leeds.ac.uk
Dr
Kulveer
Mankia
+44 113 392 ext 4884
K.S.Mankia@leeds.ac.uk
Prof
Paul
Emery
+44 113 392 ext 4884
P.Emery@leeds.ac.uk
The study is sponsored by University of Leeds and funded by Eli Lilly and Company.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 53573
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
