Clinical Effectiveness of Adalimumab (Exemptiaâ?¢) in patients suffering from symptomatic Ankylosing Spondylitis (AS) under supervised standard rheumatology care - CRD/ADL/2016/001

CENTER FOR RHEUMATIC DISEASES0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Clinical diagnosis of AS as per rheumatologist.
•Aged >=18 to <= 75 years.
•Symptomatic AS defined as satisfying 2 of the following 3 criteria anytime during the last 7 days.
•I.musculoskeletal axial Pain on VAS scale >= 3 cm (range 0 to 10 cm).
•II.Early morning stiffness >= 30 min.
•III.ESR >= 28 mm (fall at the end of the first hour â?? westergrenâ??s method ) and / or CRP >= 5 mg/l.
•Patients requiring frequent use of NSAIDs and on a stable dose of NSAIDs for at least 4 weeks.
•Duration of disease >= 2 yrs.

•1)Patients with arthritis due to any other cause except reactive arthritis.
•2)Use of any biological agent and in particular anti TNF therapy during the previous 1 year.
•3)Use of any kind of immunomodulator or immunosuppressive drugs except sulphasalzine and methotrexate during the last 3 months.
•4)Use of injectable steroids within 4 weeks prior to baseline.
•5)Pregnancy and patients (and their spouses) unwilling to use adequate contraceptive measures.
•6)History of uncontrolled and / or unstable recent onset diseases.
•7)History of any recent infection requiring antibiotics in the last 3 months.
•8)History of tuberculosis irrespective of the treatment provided.
•9)Hepatitis or human immunodeficiency virus; a significant history of cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, or hepatic disease; and a history of demyelinating disease or multiple sclerosis.
•10)History of cancer or lymphoproliferative disease other than a successfully treated non-metastatic squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
•11)H/o surgery to spine , traumatic diseases of the spine.
•12)Any kind of disqualification as per the discretion of investigator.

发起方

CENTER FOR RHEUMATIC DISEASES