A single dose clinical trial to study the safety of ART-I02 in patients with arthritis

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

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).
11. History of liver function abnormality requiring treatment, drug induced liver injury, chronic liver disease, excessive alcohol consumption or chronic alcohol induced disease.
12. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 x upper limit of normal (ULN), or bilirubin > 2 x ULN. If a patient has AST or ALT > 2 x ULN but < 2.5 x ULN, re-assessment is allowed at the investigator*s discretion.
13. Severely impaired renal function (estimated glomerular filtration rate <= 30 mL/min according to the Cockcroft-Gault formula).
14. Patient had a major surgery, donated or lost approximately 500 ml blood within 4 months prior to the screening visit
15. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude
16. Serious medical disease, such as severe liver or kidney disease, uncompensated congestive heart failure, myocardial infarction within six months, unstable angina, uncontrolled hypertension, severe pulmonary disease or active asthma, demyelinating neurological disease, depression or a history of depression, history of seizures or epilepsy, uncontrolled epilepsy, or history of cancer (other than cutaneous basal and squamous cell carcinoma or cervical intraepithelial neoplasia) with less than five years documentation of a disease-free state, recurrent opportunistic infections or other concurrent medical condition that, in the opinion of the investigator, would make the patient unsuitable for the study.
17. Investigator has concerns regarding the safe participation of the patient in the trial or for any other reasons: the investigator considers the patient inappropriate for participation in the trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and tolerability endpoints<br /><br>The primary endpoints are safety and tolerability, as assessed by:<br /><br>1. treatment emergent (serious) adverse events<br /><br>2. concomitant medication<br /><br>3. clinical laboratory tests<br /><br>a. haematology<br /><br>b. chemistry<br /><br>c. urinalysis<br /><br>4. vital signs<br /><br>a. pulse rate<br /><br>b. systolic blood pressure<br /><br>c. diastolic blood pressure<br /><br>d. body temperature<br /><br>5. and ECG parameters<br /><br>a. HR, PR, QRS, QT and Qtc</p><br>

Secondary Outcome Measures