Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 12:09 AM
NCT ID:
NCT01352858
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01352858
Study Brief:
Protocol Section:
NCT01352858