Evaluate the effectiveness and safety of Cpn10 in subjects with moderate to severe rheumatoid arthritis despite treatment with methotrexate
A multi-centre, randomised, double blind, placebo-controlled, parallel group, phase IIa clinical trial to assess the efficacy and safety of Cpn10 administered as twice weekly subcutaneous injections in subjects with Rheumatoid Arthritis
Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss
Plain Language Summary
Simplified for easier understanding
This study is looking at evaluate the effectiveness and safety of Cpn10 in subjects with moderate to severe rheumatoid arthritis despite treatment with methotrexate. It is open to both men and women, aged 18 to 80, who 1. diagnosis of ra according to the american college of rheumatology with. People with certain health conditions such as 1. diagnosed with juvenile ra. 2. history of allergic or anaphylatic reactions to cpn10. 3. treatment with any dmard other than stable doses of hydroxchloroquine, sulphasalazine, leflunomide, azothioprine, minocycline, gold or methotrexate within 3 months of screening. 4. prior treatment with more than one biological agent for ra. 5. treatment with a small molecule investigational product within 28 days prior to screening or 5 times the half-life of the drug (whichever is longer) prior to day 0. 6. administration of intra-articular or parenteral glucocorticoids within 4 weeks of screening. 7. dose of nsaid higher than the maximum recommended dose in the product information. 8. current use of narcotic analgesics other than codeine or dextropropoxyphene at screening. 9. active or latent bacterial, fungal, viral or atypical mycobacterial infections. 10. history of opportunistic infections (systemic fungal infections, parasites) within the past 6 months. 11. history of malignancy within the past 5 years (other than basal or squamous cell carcinoma or adequately treated carcinoma of the cervix). 12. any live (attenuated) or killed virus or bacterial vaccines within 14 days of day 0. 13. clinical evidence of hepatic insufficiency, liver cirrhosis or fibrosis. 14. history of viral hepatitis within 1 year prior to screening or history of drug-induced liver injury at any time prior to screening. 15. history of substance abuse within the last 5 years. 16. female who is lactating or pregnant. 17. seropositive test to hiv, hepatitis b or hepatitis c at screening. 18. white cell count < 3.2 x10^9/l. 19. platelet count < 125 x 10^9/l. 20. haemoglobin < 85 g/l. 21. aspartate transaminase (ast), alanine transaminase (alt), alkalline phosphatase (alp) or serum creatinine > 2 times the upper limit of the normal range. 22. history of active tuberculosis confirmed by a chest x-ray and quantiferon tb gold test at screening. 23. treatment with a biological agent for ra within 3 months of day 0. 24. vaccines or allergy desensitisation therapy within 14 days of day 0. 25. significant concurrent medical conditions which the investigator believes places the subject at an unaccceptable risk for participation in the trial may not be able to join. If you take part, the research team will explain what is involved and monitor your health throughout the study.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Cpn10 25 mg subcutaneous injection twice per week for 24 weeks.
Cpn10 75 mg subcutaneous injection twice per week for 24 weeks.
Cpn10 25 mg subcutaneous injection twice per week for 24 weeks.
Cpn10 75 mg subcutaneous injection twice per week for 24 weeks.
Locations(7)
Auckland, Middlemore, New Zealand
Wellington, New Zealand
Rotarua, New Zealand
Hamilton, New Zealand
Christchurch, New Zealand
North Shore Auckland, New Zealand
Nelson, New Zealand
View Full Details on ANZCTR
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