NL-OMON45686
Completed
Not Applicable
A single dose clinical trial to study the safety of ART-I02 in patients with arthritis - ART-I02 in patients with Arthritis
Arthrogen B.V.0 sites12 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- arthritis
- Sponsor
- Arthrogen B.V.
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients \>\=18 years of age
- •2\. Patient has been diagnosed with RA according to the 2010 American College of Rheumatology/ European league against rheumatism (ACR/EULAR) criteria for the classification of RA, outlined in appendix B or OA as confirmed by their treating physician/specialist.
- •3\. Patient is scheduled for surgical intervention of the target joint.
- •4\. Inflammation of the CMC, MCP, PIP or DIP joint as confirmed by MRI.
- •5\. Written informed consent, able and willing to comply with the requirements of the study protocol.
- •6\. Judged to be in general good health with, in the opinion of the investigator, no other clinically significant and relevant abnormalities of medical history, and no abnormalities at the physical examination, vital signs, electrocardiography (ECG) and laboratory safety tests, performed at the screening visit and/or prior to administration of ART\-I02\.
- •7\. Females are not pregnant nor lactating. All patients use effective contraception in combination with barrier contraception for the first three months after administration or until three consecutive semen samples are negative.
Exclusion Criteria
- •1\. Arthrodesis or joint replacement of the CMC, MCP, PIP or DIP joint prior to inclusion.
- •2\. Known hypersensitivity to natural or recombinant hIFN\-β, or to any excipients.
- •3\. Contra\-indication for intra\-articular treatment.
- •4\. Presence of neutralising antibody (Nab) titers against adeno\-associated virus type 5 (AAV5\) and/or hIFN\-β.
- •5\. Active infectious disease of any nature, including clinical active viral infections.
- •6\. Previous treatment with an AAV 5 vector.
- •7\. Poor functional status, defined as being bed\-bound.
- •8\. Participation in an investigational drug or device study within 90 days prior to screening or more than 4 times per year.
- •9\. Positive for human immunodeficiency virus (HIV) infection, hepatitis C antibodies or hepatitis B surface antigen.
- •10\. Positive for anti\-double\-stranded DNA antibodies (dsDNA).
Outcomes
Primary Outcomes
Not specified
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