Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Newcastle University
With
Arthritis Research UK
Newcastle-upon-Tyne Hospitals NHS Trust
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Able and willing to give informed consent and to comply with the study protocol
At least 6 month's disease duration
ACR Functional Class I-III
Age 18 years or over
Active disease, including an inflamed (native) knee joint
Failure (or intolerance of) at least one disease modifying anti-rheumatic drug (DMARD), including current therapy
Morning stiffness in the target joint ≥ 30 minutes
Willing and able to undergo arthroscopic procedures under local anaesthetic
Stable dose of non-steroidal anti-inflammatory drug (NSAID) or corticosteroid (prednisolone≤10mg) for ≥4 weeks
No intramuscular glucocorticoid administration for ≥ 6 weeks
Stable dose of disease-modifying anti-rheumatic drug (DMARD) for ≥8 weeks
You may not be if
Use of other investigational medicinal products within 30 days prior to study entry (defined as date of recruitment into study)
Patients who have received rituximab therapy and whose B-cell count remains below the normal range. Patients who have received any other cell depleting therapies and whose cell counts have not returned to the normal range, at the discretion of the principal investigator.
Serious or unstable co-morbidity deemed unsuitable by PI, eg. COPD, cardiac failure
History of malignancy (except treated basal cell carcinoma of skin)
Known active infection at screening visit or at baseline (except fungal nail infection)
Infection requiring hospitalization or IV antibiotics within 6 weeks of baseline
Immunization with live vaccine within 6 weeks of baseline
History of recurrent or chronic infection
History of hepatitis B or C, syphilis, HIV or HTLV-1/2 infections
Injection of target joint with glucocorticoids within 6 weeks of baseline
Hb\<10g/dL; neutrophils\< 2.00 x109/L; platelets \<150x109/L; ALT/ALP\>2x upper limit of normal; elevated serum creatinine at screening visit.
Major surgery within 8 weeks of baseline or planned within 3 months from baseline
Pregnancy, or women planning to become pregnant within the study period, or women who are breast feeding
Females or males of child bearing potential unwilling to use adequate contraception for duration of study
Patients taking anticoagulants
Known hypersensitivity to local or systemic corticosteroid therapy or local anaesthetic.
Poor venous access or medical condition precluding leukapheresis
