ActivePhase 2ACTRN12608000208303

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

Sponsor

CBio Limited

Enrollment

150 participants

Start Date

May 1, 2008

Study Type

Interventional

Conditions

Rheumatoid Arthritis (RA)

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria13

Diagnosis of RA according to the American College of Rheumatology with
RA Functional Class I-III.
Diagnosed at least 6 months prior to screening.
Failed at least one disease modifying anti-rheumatic drug (DMARD), but not more than five.
Taking methotrexate for at least 3 months prior to screening and at a stable maximum tolerated dose for at least 1 month prior to screening.
Any other DMARD (if taken) must have been taken for at least 3 months and be taken at a stable dose for at least one month prior to screening.
Active RA despite stable methotrexate at a maximum tolerated dose. Active RA defined as a DAS28>3.2 and at least 6 tender and swollen joints of 68 examined and either an ESR>25mm/hr or a CRP>10mg/mL.
weight <120kg.
Prednisolone (or equivalent) (if taken) must be at a dose of no more than 10 mg/ day and stable for at least one month prior to screening.
Non-steroidal anti-inflammatory drugs (NSAIDS) (if taken) must be at a stable dose for at least one month prior to screening.
In general good health other than RA.
Use a medically reliable method of contraception throughout the study.
Provide written informed consent.

Exclusion Criteria1

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.

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