None listed
Conditions
Brief summary
Test the safety and effectiveness of Cpn10 in patients with rheumatoid arthritis. The study personnel, patient and sponsor are all blinded to which of the three doses of Cpn10 is administered.
Interventions
Cpn10 7.5mg twice a week or
Cpn10 10mg twice per week
given as intravenous injections for 12 weeks
Sponsors
CBio Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Fulfils the 1987 American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis2. Onset of RA after 18 years of age3. Disease duration of at least 6 months4. Stable dose of DMARD, including hydroxychloroquine, sulphasalazine or methotrexate for at least 3 months prior to screening. Patients taking more than one DMARD are allowed entry into the trial but these patients cannot be taking more than one immunosuppressive drug. Patients using leflunomide and another immunosuppressive may be considered for trial inclusion, however, leflunomide must be washed out with cholestyramine for 11 days. These patients may only be enrolled at least 30 days after the last dose of cholestyramine.5. Active RA defined as 8 tender joints of the 68 examined and 8 swollen joints of 66 examined, ESR greater than or equal to 28 mm/hour, OR CRP greater than or equal tp 10 mg/L, OR morning stiffness greater than or equal to 45minutes.6. ACR functional class I-III7. Male or female aged 18-75 years and generally in good health as determined by medical history, physical examination, vital signs, ECG and routine laboratory tests at screening8. Body weight < 120kg9. Able and willing to comply with the study protocol.10. Negative serum pregnancy test taken at screening in all women except those surgically sterile or are at least 2 years postmenopausal. 11. Sexually active women of child bearing potential must agree to use a medically reliable method of preventing conception for the duration of the study, unless surgically sterile or post menopausal. 12. Sexually active men whose partners are of childbearing potential must agree to use a medically reliable method of preventing conception for the duration of the study, unless surgically sterile.13. Have provided written informed consent to participate in the trial.14. DAS 28 > 3.2 at screening.
Exclusion criteria
1. Stable dose of DMARD, including hydroxychloroquine, sulphasalazine or methotrexate for at least 3 months prior to screening. Patients taking more than one DMARD are allowed entry into the trial but these patients cannot be taking more than one immunosuppressive drug. Patients using leflunomide and another immunosuppressive may be considered for trial inclusion, however, leflunomide must be washed out with cholestyramine for 11 days. These patients may only be enrolled at least 30 days after the last dose of cholestyramine.2. Treatment with an investigational agent within 3 months prior to screening 3. Prior treatment with anti-TNF-alpha agents 4. Treatment with more than one NSAID within 4 weeks prior to screening.5. Dose of NSAID greater than the maximum recommended dose in the product information. 6. Current use of narcotic analgesics other than codeine at the screening visit. 7. Current use of more than 10 mg/day of prednisone or equivalent.8. Treatment with intra-articular corticosteroid injection within 3 weeks prior to screening.9. Patients with active or latent bacterial, fungal or viral infections at the time of screening 10. History of malignancy within the past 5 years (other than basal cell carcinoma or adequately treated carcinoma-in-situ of the cervix).11. Receipt of any live (attenuated) vaccines within 4 weeks before screening visit.12. Significant concurrent medical diseases including metabolic, haematologic, cardiac, renal, hepatic, infectious, psychiatric or gastrointestinal conditions which in the opinion of the Investigator places the patient at unacceptable risk for participation in the study.13. Liver function abnormality (SGOT/AST, SGPT/ALT: > 2 x upper limit of normal) or clinical evidence of hepatic insufficiency; liver cirrhosis or fibrosis. 14. History of any viral hepatitis within 1 year prior to screening or history of any drug-induced liver injury at any time prior to screening.15. Have a seropositive test to HIV, Hepatitis B or Hepatitis C at screening.16. Renal disease (creatinine level > 175 umol/L).17. Leukopenia (white blood cells < 3500 x 10^6/L).18. Thrombocytopenia (platelets < 125 x 10^9/L).19. Haemoglobin < 84 g/L (5.2 mmol/l).20. Have a history of active tuberculosis confirmed by a chest X-ray and Quantiferon TB gold testing at screening.
Outcome results
None listed