None listed
Conditions
Brief summary
The aim of this study is to investigate if the treatment of rheumatoid arthritis (RA) based on the results of analysis of a biopsy of the involved joint lining is better than usual therapy (not based on the results of biopsy). The way standard care or bDMARD therapy will be chosen will be by the process called randomization (which will happen only once at the beginning of the study), which essentially is the equivalent of tossing a coin and deciding the treatment option on the basis of the result. This gives equal chance of going to either the bDMARD or standard care treatment arm. Once the patient has chosen to participate, they will receive an arthroscopic biopsy from the lining of an inflamed joint (called the synovium). The bDMARD will be chosen on the basis of the biopsy.
Interventions
This trial will randomize patients to either of 2 arms; both arms will have an arthroscopic synovial biopsy at the onset and at 6 months. The arthroscopic synovial biopsy is expected to take around 30 minutes, and will be done with a small bore arthroscopy; the site will of arthroscopy will be a clinically involved joint and the procedure will be done in the operating theatre under an anaesthetic agent (type of anaesthesia as per the anaesthesiologist's preference).
The first arm will be the s
This trial will randomize patients to either of 2 arms; both arms will have an arthroscopic synovial biopsy at the onset and at 6 months. The arthroscopic synovial biopsy is expected to take around 30 minutes, and will be done with a small bore arthroscopy; the site will of arthroscopy will be a clinically involved joint and the procedure will be done in the operating theatre under an anaesthetic agent (type of anaesthesia as per the anaesthesiologist's preference). The first arm will be the study group (will commence immediately post synovial biopsy). Participants in this group will receive a biologic disease modifying anti rheumatic drug (bDMARD), either abatacept (T cell co stimulation inhibitor, abatacept administered subcutaneously- 125 mg weekly after a single intravenous dose of ~10 mg/kg ) or a tumor necrosis factor (TNF) inhibitor (adalimumab, subcutaneously 40 mg every other week), depending on the immunohistochemistry of their synovium. The bDMARD will be given for 6 months. The other arm will be the comparator arm.
Sponsors
Assoc Professor Mihir D Wechalekar
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Anti cyclic citrullinated peptide (CCP) positive active (>/=2 joints) rheumatoid arthritis, duration of disease </=12 months
Exclusion criteria
Previously received DMARD/ bDMARD for RA; ANA positive >320, hepatitis B/ C/ HIV positivity, concomitant treatment with experimental drug
Outcome results
None listed