I CEA. Induction of Cure in Early ArthritisA single blind randomized clinical trial

Eli Lilly and Company0 个研究点目标入组 300 人开始时间: 待定最近更新: 2024年2月28日

试验速览

expected in leading rheumatology journals

•18 years or older, able to give written informed consent (in Dutch or English) and fill out questionnaires in Dutch (or English version, if available), undifferentiated arthritis with symptom duration <1 year, not fulfilling classification criteria for rheumatoid arthritis, other diagnoses causing the arthritis rejected, Disease Activity Score >1.6

•Contraindications to use of study medication or reasonable alternatives
•Wish to become pregnant, breastfeed or father a child during the study
•Alcohol- or substance abuse
•Immuno-compromised state either based on co-morbidity or co-medication
•Leucopenia <3*10^9/l, and/or neutropenia <1*10^9/l
•Hemoglobin <5 mmol/l
•Increased liver enzymes > 3x upper limit of normal
•Renal insufficiency with estimated creatinine clearance <40%
•Interstitial lung disease as seen on X-thorax
•Maintenance treatment with corticosteroids exceeding prednisone 10 mg daily or equivalent
•Active or ongoing chronic infection, (recurrent) serious infection(s) in past 4 months, latent TB who refuse anti-tuberculous treatment, hepatitis B with positive DNA viral load or hepatitis C with positive RNA viral load, patients with anti-HB2 and anti-HBc antibodies who refuse monitoring of hepatitis B DNA expression

发起方