Prospective study on the effects of withdrawal of anti-TNF therapy in patients with rheumatoid arthritis who are in remission- stop-study - AMC STOP

Academisch Medisch Centrum0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Men/women suffering from rheumatoid arthritis, based on the 2010 American College of Rheumatology/ European league Against Rheumatism (ACR/EULAR) classification criteria for RA will be included in this study.;Patients in ARA functional classes I, II, and III may be included.;In addition, patients must fulfill the following criteria at baseline:
•1) DAS 28 * 2.6 for the duration of a minimum of 24 weeks
•2) Be > 18 years of age and * 85 years.
•3) Stable use of concomitant DMARDs and TNF antagonists for the duration of 24 weeks before baseline

•1) The use of oral/ intra-articular corticosteroids within 6 months prior to baseline
•2) Pregnancy
•3) Breastfeeding
•4) Subjects who are impaired, incapacitated, or incapable of completing study
•related assessments.
•5) Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus
•erythematous).
•6) Subjects with active vasculitis of a major organ system with the exception of
•rheumatoid nodules.
•7) Subjects with current symptoms of severe, progressive, or uncontrolled renal,
•hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or
•cerebral disease, or other medical conditions that, in the opinion of the
•investigator, might place the subject at unacceptable risk for participation in this
•8) Subjects who have clinically significant drug or alcohol abuse.
•9) Inability to give informed consent
•10) Mental condition rendering the patient unable to understand the na¬ture, scope
•and possible consequences of the study and/or evidence of an uncooperative attitude.

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