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Trial registered on ANZCTR


Registration number
ACTRN12609000078257
Ethics application status
Approved
Date submitted
23/12/2008
Date registered
2/02/2009
Date last updated
2/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluate the ongoing effectiveness and safety of Cpn10 in rheumatoid arthritis
Scientific title
A mulit-centre, long term follow-up, open label trial to assess the efficacy and safety of Cpn10 in subjects with rheumatoid arthritis (Protocol number CBIO2008-01)
Secondary ID [1] 253529 0
CBIO2008-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis (RA) 4156 0
Condition category
Condition code
Inflammatory and Immune System 4366 4366 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cpn10 25 mg subcutaneous injection twice per week for 72 weeks
Cpn10 75 mg subcutaneous injection twice per week for 72 weeks
The dose of Cpn10 may be escalated from 25mg to 75mg twice per week, after the first 4 weeks of the study, if the participant shows a response. The investigator may taper concurrent RA treatments after 3 months on study if hte participant is continuing with a good response to Cpn10
Intervention code [1] 3874 0
Treatment: Drugs
Comparator / control treatment
no control or comparator group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5241 0
Percentage of participants maintaining an ACR20 response (at least a 20% improvement in core disease measures according to the American College of Rheumatology (ACR) response criteria). The ACR20 is a standard measure used in clinical trials in RA. Outcomes measured to assess the improvement include tender and swollen joint counts assessed by physical examination by a health care professional, the participant's assessment of disease activity and pain on a scale of 0 to 100, the health care professional's assessment of disease activity on a scale of 0 to 100, the participant's assessment of functional disability by a questionnaire and a laboratory test for the erythrocyte sedimentation rate.
Timepoint [1] 5241 0
at 6, 12 and 18 months (24, 48 and 72 weeks)
Secondary outcome [1] 8827 0
Percentage of participants maintaining an ACR50 response (at least a 50% improvement in core disease measures according to the American College of Rheumatology (ACR) response criteria). Assessments and methods used to make the assessments are identical to the ACR20.
Timepoint [1] 8827 0
at 6, 12 and 18 months (24, 48 and 72 weeks)
Secondary outcome [2] 8828 0
Percentage of participants maintaining an ACR70 response (at least a 70% improvement in core disease measures according to the American College of Rheumatology (ACR) response criteria). Assessments and methods used to make the assessments are identical to the ACR20.
Timepoint [2] 8828 0
at 6, 12 and 18 months (24, 48, 72 weeks)
Secondary outcome [3] 8829 0
Disease Activity Score (DAS28) using the 28 joint count- DAS Score and DAS responder status. The DAS is a standard measure used in clinical trials for RA. Outcomes measured to assess the improvement include tender and swollen joint counts assessed by physical examination by a health care professional, the participant's assessment of disease activity on a scale of 0 to 100, and a laboratory test for the erythrocyte sedimentation rate.
Timepoint [3] 8829 0
at 6, 12 and 18 months (24, 48, 72 weeks)
Secondary outcome [4] 8830 0
Tender and Swollen Joint counts will be assessed by a physical examination by a health care professional
Timepoint [4] 8830 0
at 6, 12 and 18 months (24, 48, 72 weeks)
Secondary outcome [5] 8831 0
Length of early morning joint stiffness recorded by the subject in a diary for the last week
Timepoint [5] 8831 0
at 6, 12 and 18 months (24, 48, 72 weeks)
Secondary outcome [6] 8832 0
Physician global assessment of disease activity is assessed by the health care profession and scored on a scale of 0 to 100
Timepoint [6] 8832 0
at 6, 12 and 18 months (24, 48, 72 weeks)
Secondary outcome [7] 8833 0
Patient global assessment of disease activity, pain and fatigue will be scored on a scale of 0 to 100.
Timepoint [7] 8833 0
at 6, 12 and 18 months (24, 48, 72 weeks)
Secondary outcome [8] 8834 0
Erythrocyte sedimentation rate (ESR) is measured by a laboratory test
Timepoint [8] 8834 0
at 6, 12 and 18 months (24, 48, 72 weeks)
Secondary outcome [9] 8835 0
C-Reactive Protein (CRP) is measured by a laboratory test.
Timepoint [9] 8835 0
6, 12 and 18 months (24, 48, 72 weeks)
Secondary outcome [10] 8836 0
Health Assessment Questionnaire (HAQ)
Timepoint [10] 8836 0
at 6, 12 and 18 months (24, 48, 72 weeks)
Secondary outcome [11] 8837 0
Short Form 36 Questionnaire (SF36) is used to assess the participant's health related quality of life.
Timepoint [11] 8837 0
at 6, 12 and 18 months (24, 48, 72 weeks)
Secondary outcome [12] 8838 0
Functional Assessment of Chronic Illness Therapy (FACIT)
Timepoint [12] 8838 0
at 6, 12 and 18 months (24, 48, 72 weeks)
Secondary outcome [13] 8839 0
Development of new bone erosions evaluated by x-ray
Timepoint [13] 8839 0
at 6 and 18 months (24, 72 weeks)

Eligibility
Key inclusion criteria
1. Participants must have completed Protocol CBIO2007-01
2. In general good health other than RA
3. For females a negative pregnancy test at screening, unless surgically sterile or at least 2 years post menopausal
4. Use of a medically reliable method of contraception throughout the study
5. 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. History of allergic or anaphylactic reactions to Cpn10
2. Active or latent bacterial, fungal, viral or atypical mycobacterial infections at the time of screening that the investigator deems clinically significant
3. Females who are lactating or pregnant
4. Significant concurrent medical diseases including metabolic, haematological, cardiac, renal, hepatic, infectious, psychiatric or gastrointestinal conditions which in the opinion of the investigator places the study participant at an unacceptable risk for participation in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
All participants completing Protocol CBIO2007-01 will be considered for enrolment in the study. The dose of Cpn10 will be dependent upon the dose that the participant was taking at the completion of Protocol CBIO2007-01.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
5/01/2009
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] 1356 0
4558
Recruitment postcode(s) [2] 1357 0
3144
Recruitment postcode(s) [3] 1358 0
4870
Recruitment postcode(s) [4] 1359 0
4102
Recruitment postcode(s) [5] 1360 0
5011
Recruitment postcode(s) [6] 1361 0
6008
Recruitment postcode(s) [7] 1362 0
2194
Recruitment outside Australia
Country [1] 1494 0
New Zealand
State/province [1] 1494 0
Auckland, Middlemore
Country [2] 1495 0
New Zealand
State/province [2] 1495 0
Wellington
Country [3] 1496 0
New Zealand
State/province [3] 1496 0
Rotorua
Country [4] 1497 0
New Zealand
State/province [4] 1497 0
Hamilton
Country [5] 1498 0
New Zealand
State/province [5] 1498 0
Christchurch
Country [6] 1499 0
New Zealand
State/province [6] 1499 0
Auckland, North Shore

Funding & Sponsors
Funding source category [1] 4423 0
Commercial sector/Industry
Name [1] 4423 0
CBio Limited
Country [1] 4423 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] 3983 0
None
Name [1] 3983 0
Address [1] 3983 0
Country [1] 3983 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6380 0
Northside Health Service District, Redcliffe-Caboolture Ethics Committee
Ethics committee address [1] 6380 0
Ethics committee country [1] 6380 0
Australia
Date submitted for ethics approval [1] 6380 0
Approval date [1] 6380 0
08/10/2008
Ethics approval number [1] 6380 0

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

Contacts
Principal investigator
Name 35060 0
Address 35060 0
Country 35060 0
Phone 35060 0
Fax 35060 0
Email 35060 0
Contact person for public queries
Name 12407 0
Melanie Farris
Address 12407 0
CBio Limited
85 Brandl St
Eight Mile Plains
QLD 4113
Country 12407 0
Australia
Phone 12407 0
+61 7 3481 4844
Fax 12407 0
+61 7 3841 8189
Email 12407 0
melanie.farris@cbio.com.au
Contact person for scientific queries
Name 3335 0
Bronwyn Williams
Address 3335 0
85 Brandl St
Eight Mile Plains
QLD 4113
Country 3335 0
Australia
Phone 3335 0
+61 7 3841 4844
Fax 3335 0
+61 7 3841 8189
Email 3335 0
bronwyn.williams@cbio.com.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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