Induction of Cure in Early Arthritis - I CEA

eiden University Medical Center0 个研究点目标入组 309 人开始时间: 2020年6月10日最近更新: 2021年11月15日

适应症

试验速览

暂无简介。

•-=18 year of age and able to give written informed consent (in Dutch or English) and fill out questionnaires in Dutch (or English version, if available)
•-Clinical early unclassified arthritis of at least one joint, not fulfilling ACR/EULAR 2010 criteria for rheumatoid arthritis
•-Symptom duration of arthritis <1 year
•-Other diagnoses causing the arthritis rejected (including infection, (pseudo-)gout, psoriatic arthritis, non-rheumatoid auto-immune disease, paraneoplastic arthritis)
•-DAS>1.6
•-No wish to become pregnant, breastfeed or father a child during the study
•-No contraindications to treatment with NSAIDs, MTX (or sulfasalazine or leflunomide as alternative) and baricitinib as required in the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 245
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 64

•-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
•-Increased tendency to develop arterial or venous thrombosis. Assessed by the treating rheumatologist based on family history and medical history of the patient.

发起方

eiden University Medical Center