Status:
UNKNOWN
ART-I02 in Patients With Rheumatoid Arthritis With Inflamed Wrists
Lead Sponsor:
Arthrogen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety and tolerability of a single intra-articular administration of ART-I02 (AAV5.NF-kB.IFN-β), a recombinant adeno-associated virus (AAV) type 5 vector in subjects with...
Detailed Description
DMARDs such as methotrexate, sulfasalazine and leflunomide used alone or in combination, are considered to be standard treatment for RA and may be combined with other conventional DMARDs and/or cortic...
Eligibility Criteria
Inclusion
- Patients with RA aged ≥18 years.
- 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 A.
- Inflammation of the target wrist due to active RA as confirmed by MRI, and the (symptoms of) inflammation is (are) not satisfactorily controlled by current best-standard therapy, and/or that the patient could benefit from better therapeutic efficacy, according to judgment of the investigator.
- Written informed consent, able and willing to comply with the requirements of the study protocol.
- 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.
- Females are not pregnant nor lactating.
- All male patients use effective contraception in combination with barrier contraception until three consecutive semen samples are negative for ART-I02 genomic DNA. All female patients of childbearing potential use effective contraception in combination with barrier contraception for the first three months after administration.
Exclusion
- Arthrodesis or joint replacement of the target wrist prior to inclusion.
- Known hypersensitivity to natural or recombinant hIFN-β, or to any excipients.
- Contra-indication for intra-articular treatment.
- Presence of neutralizing antibody (Nab) titers against adeno-associated virus type 5 (AAV5) and/or hIFN-β.
- Active infectious disease of any nature, including clinical active viral infections.
- Previous treatment with an AAV 5 vector.
- Poor functional status, defined as being bed-bound or wheelchair-bound.
- Intra-articular corticosteroid treatment within one month prior to administration of the study medication.
- Participation in an investigational drug or device study within 90 days prior to screening or more than 4 times per year.
- Positive for human immunodeficiency virus (HIV) infection, hepatitis C antibodies or hepatitis B surface antigen.
- Positive for anti-double-stranded DNA antibodies (dsDNA).
- History of liver function abnormality requiring treatment, drug induced liver injury, chronic liver disease, excessive alcohol consumption or chronic alcohol induced disease.
- 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.
- Severely impaired renal function (estimated glomerular filtration rate ≤ 30 mL/min according to the Cockcroft-Gault formula).
- Patient had a major surgery, donated or lost approximately 500 mL blood within 4 months prior to the screening visit
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
- 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.
- 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.
- \-
Key Trial Info
Start Date :
January 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03445715
Start Date
January 3 2018
End Date
January 1 2020
Last Update
November 14 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Calgary, Division of Rheumatology, Cumming School of Medicine
Calgary, Canada, AB T2N 4N1