None listed
Conditions
Brief summary
This study aims to determine the efficacy of Adalimumab for active hand osteoarthritis. Primary hypothesis is Adalimumab will be superior to placebo for pain at 3 months in osteoarthritis of the hand. The design is a randomised, double blind, placebo controlled, crossover trial. Subjects will be randomised to Adalimumab/placebo followed by a 60 day washout and then the converse Adalimumab/placebo.
Interventions
Adalimumab 40 mg subcutaneous injection eow (every other week) for 3 months, crossover with 60 day washout.
Sponsors
University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Hand OA based on physician diagnosis and ACR criteria. Hand pain >50 on 100mm VAS. Morning stiffness >30 minutes. Subject is judged to be in good general health as determined by the Prinicpal Investigator based upon results of medical history, physical examination, laboratory profile and chest X-ray (CXR). Subject has negative QuantiFERON-TB Gold test and negative CXR (PA and lateral view). Subjects must be able and willing to provide written informed consent and to comply with the requirements of the study.
Exclusion criteria
A subject will not be eligable for study participation if he/she meets any of the following criteria: Subject has been treated with any investigational drug of a chemical or biologic nature with a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to baseline visit. Any infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to baseline visit or oral anti-infectives within 14 days prior to baseline visit. Known hypersensitivity to adalimumab or its excipients. History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease. History of invasive infection (e.g., listeriosis and histoplasmosis), human immunodeficiency syndrome (HIV), or chronic or active Hepatitis C. Subjects with an active systemic viral infection or any active viral infection that based on the investigator's clinical assessment make the subject an unsuitable candidate for the study. Hepatitis B: HBs Ag positive (+) or detected sensitivity on the HBV-DNA PCR qualitative test for HBc Ab/HBs ab positive subjects. Chronic recurring infections or active TB. History of moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix. Subject received any live vaccine within 3 months prior to study drug administration. Subject has a history of clinically significant hematologic (e.g., severe anaemia, leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis, hepatitis). History of clinically significant drug or alcohol abuse in the last 12 months. Clinically significant abnormal screening laboratory results as evaluated by the investigator. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Outcome results
None listed