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Trial registered on ANZCTR


Registration number
ACTRN12608000208303
Ethics application status
Approved
Date submitted
16/04/2008
Date registered
18/04/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluate the effectiveness and safety of Cpn10 in subjects with moderate to severe rheumatoid arthritis despite treatment with methotrexate
Scientific title
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
Secondary ID [1] 549 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis (RA) 3067 0
Condition category
Condition code
Inflammatory and Immune System 3221 3221 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cpn10 25 mg subcutaneous injection twice per week for 24 weeks.
Cpn10 75 mg subcutaneous injection twice per week for 24 weeks.
Intervention code [1] 2810 0
Treatment: Drugs
Comparator / control treatment
All subjects will be taking methotrexate, either oral or intramuscular, at the maximum tolerated dose which is tailored for each individual subject. The control group will be receiving placebo Cpn10.
Control group
Placebo

Outcomes
Primary outcome [1] 4104 0
Percentage of subjects achieving at least a 20% improvement in core disease measures according to the American College of Rheumatology (ACR) response criteria-ACR20.
Timepoint [1] 4104 0
at 12 weeks
Secondary outcome [1] 6907 0
Percentage of subjects achieving an ACR20 response.
Timepoint [1] 6907 0
at 2, 4, 6, 8, 16, 20 and 24 weeks.
Secondary outcome [2] 6908 0
Percentage of subjects achieving at least a 50% improvement in core disease measures according to ACR- ACR50 response.
Timepoint [2] 6908 0
at 2, 4, 6, 8, 10, 12 ,16, 20 and 24 weeks.
Secondary outcome [3] 6909 0
Percentage of subjects achieving at least a 70% improvement in core disease measures according to ACR- ACR70 response.
Timepoint [3] 6909 0
at 2, 4, 6, 8, 10, 12, 16, 20 and 24 weeks.
Secondary outcome [4] 6910 0
Disease Activity Score (DAS) using the 28 joint count- DAS28 score and DAS responder status.
Timepoint [4] 6910 0
at 2, 4, 6, 8, 10, 12, 16, 20 and 24 weeks.
Secondary outcome [5] 6911 0
Tender and swollen joint counts
Timepoint [5] 6911 0
at 2, 4, 6, 8, 10, 12, 16, 20 and 24 weeks.
Secondary outcome [6] 6912 0
Erythrocyte sedimentation rate (ESR)
Timepoint [6] 6912 0
at 2, 4, 6, 8, 10, 12, 16, 20 and 24 weeks.
Secondary outcome [7] 6913 0
C-reactive protein (CRP) level measured in the blood
Timepoint [7] 6913 0
at 2, 4, 6, 8, 10, 12, 16, 20 and 24 weeks.
Secondary outcome [8] 6914 0
Health assessment questionnaire (HAQ)
Timepoint [8] 6914 0
at 2, 4, 6, 8, 10, 12, 16, 20 and 24 weeks.
Secondary outcome [9] 6915 0
Length of Early morning joint stiffness recorded by the subject in a diary for the last week.
Timepoint [9] 6915 0
at 2, 4, 6, 8, 10, 12, 16, 20 and 24 weeks.
Secondary outcome [10] 6916 0
Physician Global Assessment
Timepoint [10] 6916 0
at 2, 4, 6, 8, 10, 12, 16, 20 and 24 weeks.
Secondary outcome [11] 6917 0
Patient Global assessment of disease activity, pain and fatigue.
Timepoint [11] 6917 0
at 2, 4, 6, 8, 10, 12, 16, 20 and 24 weeks.
Secondary outcome [12] 6918 0
Short form 36 questionnaire (SF-36)
Timepoint [12] 6918 0
at 4, 8, 12, 16, 20 and 24 weeks.
Secondary outcome [13] 6919 0
FACIT- fatigue scale
Timepoint [13] 6919 0
at 4, 8, 12, 16, 20 and 24 weeks.
Secondary outcome [14] 263830 0
American College of Rheumatology - N (ACR-N)
ACR-N is a continuous index that can detect smaller variations in improvement and deterioration and therefore may be a more sensitive measure of efficacy than the standard ACR responses.
Timepoint [14] 263830 0
at 2, 4, 8, 12, 16, 20 and 24 Weeks

Eligibility
Key inclusion criteria
1. Diagnosis of RA according to the American College of Rheumatology with
RA Functional Class I-III.
2. Diagnosed at least 6 months prior to screening.
3. Failed at least one disease modifying anti-rheumatic drug (DMARD), but not more than five.
4. 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.
5. 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.
6. 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.
7. weight <120kg.
8. 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.
9. Non-steroidal anti-inflammatory drugs (NSAIDS) (if taken) must be at a stable dose for at least one month prior to screening.
10. In general good health other than RA.
11. Use a medically reliable method of contraception throughout the study.
12. Provide written informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

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)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified according to disease duration (<2 or > 2 years) and centre.
Randomisation by a minimisation method.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Rescue arm at 12 weeks for non-responders. There are two sub-studies (pharmacokinetic and a pharmacodynamic) at selected centres who have agreed to participate. 30 subjects of the 150 in the trial will be recruited to the pharmacokinetic sub-study and 50 subjects will be recruited to the pharmacodynamic sub-study
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 649 0
4558
Recruitment postcode(s) [2] 650 0
3144
Recruitment postcode(s) [3] 651 0
4870
Recruitment postcode(s) [4] 652 0
4102
Recruitment postcode(s) [5] 653 0
5011
Recruitment postcode(s) [6] 654 0
6008
Recruitment postcode(s) [7] 963 0
2194
Recruitment outside Australia
Country [1] 916 0
New Zealand
State/province [1] 916 0
Auckland, Middlemore
Country [2] 917 0
New Zealand
State/province [2] 917 0
Wellington
Country [3] 918 0
New Zealand
State/province [3] 918 0
Rotarua
Country [4] 919 0
New Zealand
State/province [4] 919 0
Hamilton
Country [5] 920 0
New Zealand
State/province [5] 920 0
Christchurch
Country [6] 921 0
New Zealand
State/province [6] 921 0
North Shore Auckland
Country [7] 922 0
New Zealand
State/province [7] 922 0
Nelson

Funding & Sponsors
Funding source category [1] 3314 0
Commercial sector/Industry
Name [1] 3314 0
CBio Limited
Country [1] 3314 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] 2965 0
None
Name [1] 2965 0
Address [1] 2965 0
Country [1] 2965 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5330 0
Redcliffe-Caboolture Ethics Committee
Ethics committee address [1] 5330 0
Redcliffe Hospital
Anzac Ave
Redcliffe QLD 4020
Ethics committee country [1] 5330 0
Australia
Date submitted for ethics approval [1] 5330 0
Approval date [1] 5330 0
06/02/2008
Ethics approval number [1] 5330 0
EC00171
Ethics committee name [2] 5331 0
Bellberry Human Research Ethics Committee
Ethics committee address [2] 5331 0
71 Anzac Highway
Ashford SA 5035
Ethics committee country [2] 5331 0
Australia
Date submitted for ethics approval [2] 5331 0
Approval date [2] 5331 0
29/11/2007
Ethics approval number [2] 5331 0
EC00372
Ethics committee name [3] 5332 0
Cairns Base Hospital Ethics Committee
Ethics committee address [3] 5332 0
Cairns Base Hospital
The Esplanade
Cairns QLD 4870
Ethics committee country [3] 5332 0
Australia
Date submitted for ethics approval [3] 5332 0
Approval date [3] 5332 0
13/12/2007
Ethics approval number [3] 5332 0
EC00157
Ethics committee name [4] 5333 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [4] 5333 0
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba QLD 4102
Ethics committee country [4] 5333 0
Australia
Date submitted for ethics approval [4] 5333 0
Approval date [4] 5333 0
05/11/2007
Ethics approval number [4] 5333 0
EC00167
Ethics committee name [5] 5334 0
Ethics of Human Research Committee (TQEH & LMH)
Ethics committee address [5] 5334 0
The Queen Elizabeth Hospital
28 Woodville Rd
Woodvile South SA 5011
Ethics committee country [5] 5334 0
Australia
Date submitted for ethics approval [5] 5334 0
Approval date [5] 5334 0
14/03/2008
Ethics approval number [5] 5334 0
EC00190
Ethics committee name [6] 5335 0
Royal Perth Hospital Ethics Committee
Ethics committee address [6] 5335 0
Kirkman House
Wellington St Campus
Box X2213 GPO, Perth 6847
Ethics committee country [6] 5335 0
Australia
Date submitted for ethics approval [6] 5335 0
Approval date [6] 5335 0
15/02/2008
Ethics approval number [6] 5335 0
EC00270
Ethics committee name [7] 5336 0
Multi-Region Ethics Committee
Ethics committee address [7] 5336 0
Ministry of Health
Level 2, 1-3 The Terrace
PO Box 5013 Wellington
Ethics committee country [7] 5336 0
New Zealand
Date submitted for ethics approval [7] 5336 0
Approval date [7] 5336 0
15/02/2008
Ethics approval number [7] 5336 0
Ethics committee name [8] 243864 0
Gold Coast Hospital Health Service District Human Research Ethics Committee
Ethics committee address [8] 243864 0
108 Nerang Street
Southport QLD 4215
Ethics committee country [8] 243864 0
Australia
Date submitted for ethics approval [8] 243864 0
Approval date [8] 243864 0
02/07/2009
Ethics approval number [8] 243864 0
New ethics HREC. Please modify.
Ethics committee name [9] 243865 0
Royal Brisbane and Women?s Hospital Human Research Ethics Committee
Ethics committee address [9] 243865 0
Level 7, Block 7, Royal Brisbane and Women?s Hospital, Butterfield Street
Herston 4029
Ethics committee country [9] 243865 0
Australia
Date submitted for ethics approval [9] 243865 0
Approval date [9] 243865 0
03/08/2009
Ethics approval number [9] 243865 0
New ethics HREC. Please modify.
Ethics committee name [10] 258776 0
Institute for Rheumatology
Ethics committee address [10] 258776 0
Belgrade, Resavska 69
Ethics committee country [10] 258776 0
Serbia and Montenegro
Date submitted for ethics approval [10] 258776 0
Approval date [10] 258776 0
12/12/2009
Ethics approval number [10] 258776 0
New ethics HREC. Please modify.
Ethics committee name [11] 258777 0
Institute for Treatment and Rehabilitation
Ethics committee address [11] 258777 0
Srpskih junaka 2
18205 Niska Banja
Ethics committee country [11] 258777 0
Serbia and Montenegro
Date submitted for ethics approval [11] 258777 0
Approval date [11] 258777 0
29/12/2009
Ethics approval number [11] 258777 0
New ethics HREC. Please modify.
Ethics committee name [12] 258778 0
Clinical-Hospital Centre Zemun- Belgrade
Ethics committee address [12] 258778 0
Vukova9, 11080
Zemun Belgrade
Ethics committee country [12] 258778 0
Serbia and Montenegro
Date submitted for ethics approval [12] 258778 0
Approval date [12] 258778 0
03/12/2009
Ethics approval number [12] 258778 0
New ethics HREC. Please modify.
Ethics committee name [13] 258779 0
University Clinical Centre Banja Luka
Ethics committee address [13] 258779 0
12 beba bb,Banja Luka 78000
Ethics committee country [13] 258779 0
Bosnia and Herzegovina
Date submitted for ethics approval [13] 258779 0
Approval date [13] 258779 0
28/01/2010
Ethics approval number [13] 258779 0
New ethics HREC. Please modify.
Ethics committee name [14] 258780 0
University Clinical Centre Tuzla,
Ethics committee address [14] 258780 0
Trnovac bb,Tuzla 75000
Ethics committee country [14] 258780 0
Bosnia and Herzegovina
Date submitted for ethics approval [14] 258780 0
Approval date [14] 258780 0
28/01/2010
Ethics approval number [14] 258780 0
New ethics HREC. Please modify.
Ethics committee name [15] 258781 0
University Clinical Centre Sarajevo
Ethics committee address [15] 258781 0
Bolnicka 25,Sarajevo 71000
Ethics committee country [15] 258781 0
Bosnia and Herzegovina
Date submitted for ethics approval [15] 258781 0
Approval date [15] 258781 0
28/01/2010
Ethics approval number [15] 258781 0
New ethics HREC. Please modify.
Ethics committee name [16] 258782 0
University Clinical Hospital Foca
Ethics committee address [16] 258782 0
Studentska bb,Foca 73300
Ethics committee country [16] 258782 0
Bosnia and Herzegovina
Date submitted for ethics approval [16] 258782 0
Approval date [16] 258782 0
28/01/2010
Ethics approval number [16] 258782 0
New ethics HREC. Please modify.
Ethics committee name [17] 258783 0
Medulla Chemotherapy and Immunotherapy Clinic
Ethics committee address [17] 258783 0
6, Jikia str.Tbilisi, 0186
Ethics committee country [17] 258783 0
Georgia
Date submitted for ethics approval [17] 258783 0
Approval date [17] 258783 0
03/02/2010
Ethics approval number [17] 258783 0
New ethics HREC. Please modify.
Ethics committee name [18] 258784 0
Ltd Academician V Tsitlanadze Scientifi
Ethics committee address [18] 258784 0
51, Uznadze str. Tbilisi, 0102
Ethics committee country [18] 258784 0
Georgia
Date submitted for ethics approval [18] 258784 0
Approval date [18] 258784 0
03/02/2010
Ethics approval number [18] 258784 0
New ethics HREC. Please modify.

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28539 0
Address 28539 0
Country 28539 0
Phone 28539 0
Fax 28539 0
Email 28539 0
Contact person for public queries
Name 11696 0
Melanie Farris
Address 11696 0
CBio Limited
85 Brandl St
Eight Mile Plains QLD 4113
Country 11696 0
Australia
Phone 11696 0
+61 7 3481 4844
Fax 11696 0
+61 7 3841 8189
Email 11696 0
[email protected]
Contact person for scientific queries
Name 2624 0
Bronwyn Williams
Address 2624 0
CBio Limited
85 Brandl St
Eight Mile Plains QLD 4113
Country 2624 0
Australia
Phone 2624 0
+61 7 3841 4844
Fax 2624 0
+61 7 3841 8189
Email 2624 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.