Seronegative Oligoarthritis of the Knee Study (SOKS) (NCT01216631) | Clinical Trial Compass
TerminatedPhase 2
Seronegative Oligoarthritis of the Knee Study (SOKS)
Stopped: Unable to recruit
United Kingdom1 participantsStarted 2010-09
Plain-language summary
The aim of this study is to establish the efficacy and duration of effect of intra-articular (IA) infliximab vs intravenous infliximab vs current standard care (IA steroid injections) in seronegative oligoarthritis. All patients will have seronegative arthritis affecting less than 5 joints but including at least one knee. 10 patients will receive IA infliximab injections to the affected knee, 10 will receive IA steroid injections to the affected knee and 10 will receive a course of intravenous infliximab. Patients will not be aware of their group as this is a placebo-controlled study.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Inflammatory oligoarthritis (4 or less active joints) with at least one swollen knee joint of at least 3 months duration
* Rheumatoid factor and anti-CCP Ab negative
* Either arthritis onset at \<45 years of age, or arthritis onset at ≥45 years of age with early morning stiffness\>30mins or raised inflammatory markers
* If under 40 years of age, clinical exclusion of a diagnosis of gout.
* If 40 years or older at screening, a prior normal examination of synovial fluid from the affected joint excluding crystal arthropathy or infection.
* Failure of methotrexate (inefficacy after \>3 month trial, intolerance or contra-indication)
* Have the capacity to understand and sign an informed consent form.
* Gender: male or female
* 18 years of age or over.
* Women must be either postmenopausal (no menstrual period for a minimum of 1 year) or surgically sterilized or in use of adequate birth control measures and have a negative serum pregnancy test on entry in the study.
* Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion.
* Are considered eligible according to the tuberculosis (TB) eligibility assessment, screening, and early detection of reactivation rules defin…