Evaluate the ongoing effectiveness and safety of Cpn10 in rheumatoid arthritis

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)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000078257

Enrollment

150

Registered

2009-02-02

Start date

2009-01-05

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will provide ongoing supply of Cpn10 for people with RA who have participated in an earlier 6 month trial with Cpn10. Many treatments for RA lose their effectiveness over time and are associated with side effects that limit their use. The primary purpose of this study is to establish if Cpn10 is safe and effective in RA over a long period.

Interventions

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

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

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

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

Outcome results