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:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT00901550
Eligibility Criteria:
Inclusion Criteria:
* Men and women, 18 years of age or older
* Clinical diagnosis of RA with a duration not more than 24 months (Fulfilled the 1987 American College of Rheumatology (ACR) criteria for RA)
* Patients at risk of developing persistent or erosive arthritis
* DAS 28 ≥ 3.2
* Prednisolone \< 10mg/day and started at least 4 weeks before baseline
* Either has ESR ≥ 28, CRP ≥ 10, presence of rheumatoid factor or anti-CCP, present of HLADRB\*0401 or DRB1\*0404, and radiographic erosions
* Informed consent
Exclusion Criteria:
* Little or no ability for self-care
* Previous treatment with DMARDs other than antimalarials
* Concomitant treatment with an experimental drug
* Malignancy within the last 5 years
* Bone marrow hypoplasia
* Clinically significant renal disease ( serum creatinine level ≥ 150µmol/L) or estimated creatinine clearance \> 75ml/min, alanine aminotransferase (ALT) exceeds the upper limit of normal
* History of any clinically significant adverse reaction to murine or chimeric proteins
* History of TB in the last 5 years
* Known to have hepatitis B, or hepatitis C
* Had an opportunistic infection (e.g. herpes zoster, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months before screening
* History or ongoing chronic or recurrent disease; renal infection, chest infection, urinary tract infection, ulcer or skin wound
* History of infected joint prosthesis and use of antibiotics for the joint
* Received intravenous antibiotics within 30 days or oral antibiotics within 14 days for screening
* History of known demyelinating diseases (multiple sclerosis or optic neuritis)
* Current signs or symptoms of severe diseases (renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, etc)
* History or concurrent CHF
* History of lymphoproliferative disease, splenomegaly
* Female of childbearing potential, unwilling to use adequate contraception during the study
* Current or recent ( within the past 3 months) pregnancy and cancer
* Active smoker, alcohol or drug abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00901550
Study Brief:
Protocol Section:
NCT00901550