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Trial registered on ANZCTR


Registration number
ACTRN12606000041550
Ethics application status
Approved
Date submitted
24/01/2006
Date registered
27/01/2006
Date last updated
18/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and Efficacy of Cpn10 in Rheumatoid Arthritis
Scientific title
A multicentre, double blind, parallel group, phase IIa clinical trial to assess the efficacy and safety of Cpn10 administered as twice weekly intravenous injections in subjects with rheumatoid arthritis
Secondary ID [1] 235 0
CBio Ltd: CBIO 2005-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 1003 0
Condition category
Condition code
Inflammatory and Immune System 1079 1079 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

Cpn10 7.5mg twice a week or
Cpn10 10mg twice per week
given as intravenous injections for 12 weeks
Intervention code [1] 857 0
Treatment: Drugs
Comparator / control treatment
Cpn10 5mg twice a week
Control group
Dose comparison

Outcomes
Primary outcome [1] 1444 0
Reduction in disease activity score (DAS28) anytime during the 12 week treatment period.
Timepoint [1] 1444 0
Anytime during the 12 week treatment period
Secondary outcome [1] 2559 0
1. Change in Tender Joint Count, Swollen Joint Count, Health Assessment Questionnaire (HAQ) and morning stiffness.
Timepoint [1] 2559 0
At 2, 4, 6, 8, 10 and 12 weeks.
Secondary outcome [2] 2560 0
2. Change in DAS28 score
Timepoint [2] 2560 0
At 2, 4, 6, 8, 10 and 12 weeks.
Secondary outcome [3] 2561 0
3. Change in Physician global assessment, patient global assessment, patient pain VAS, Patient fatigue VAS and SF-36.
Timepoint [3] 2561 0
At 2, 4, 6, 8, 10 and 12 weeks.
Secondary outcome [4] 2562 0
4. Change in CRP and ESR.
Timepoint [4] 2562 0
At 2, 4, 6, 8, 10 and 12 weeks.
Secondary outcome [5] 2563 0
5. Cytokine production by PBMC stimulated in vitro.
Timepoint [5] 2563 0
At 2, 4 and 8 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sequential code numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
sequential randomisation to one of three treatment allocation groups. Blocked random sequence allocation was generated using EXCEL.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1182 0
Commercial sector/Industry
Name [1] 1182 0
CBio Limited
Address [1] 1182 0
85 Brandl St
Eight Mile Plains QLD 4113
Country [1] 1182 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
CBio Limited
Address
85 Brandl St
Eight Mile Plains QLD 4113
Country
Australia
Secondary sponsor category [1] 1041 0
None
Name [1] 1041 0
N/A
Address [1] 1041 0
Country [1] 1041 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2498 0
Emeritus Research
Ethics committee address [1] 2498 0
291 Wattletree Rd, Malvern VIC 3144
Ethics committee country [1] 2498 0
Australia
Date submitted for ethics approval [1] 2498 0
Approval date [1] 2498 0
Ethics approval number [1] 2498 0
Ethics committee name [2] 2499 0
Sixth Avenue Specialist Centre
Ethics committee address [2] 2499 0
Cnr Sixth and Memorial Ave Cotton Tree QLD 4558
Ethics committee country [2] 2499 0
Australia
Date submitted for ethics approval [2] 2499 0
Approval date [2] 2499 0
Ethics approval number [2] 2499 0
Ethics committee name [3] 2500 0
Royal Perth Hospital Goatcher Clinical Research Unit
Ethics committee address [3] 2500 0
Shenton Park Campus Shenton Park WA 6008
Ethics committee country [3] 2500 0
Australia
Date submitted for ethics approval [3] 2500 0
Approval date [3] 2500 0
Ethics approval number [3] 2500 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36293 0
Address 36293 0
Country 36293 0
Phone 36293 0
Fax 36293 0
Email 36293 0
Contact person for public queries
Name 10046 0
Bronwyn Williams
Address 10046 0
CBio Limited
85 Brandl St
Eight Mile Plains QLD 4113
Country 10046 0
Australia
Phone 10046 0
+61 7 38414844
Fax 10046 0
+61 7 38428189
Email 10046 0
bronwyn.williams@cbio.com.au
Contact person for scientific queries
Name 974 0
Dr Dennis Feeney
Address 974 0
CBio Limited
85 Brandl St
Eight Mile Plains QLD 4113
Country 974 0
Australia
Phone 974 0
+61 7 38414844
Fax 974 0
+61 7 38428189
Email 974 0
dennis.feeney@cbio.com.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary