Efficacy of oral steroids in axial spondyloarthropathy: Modified COBRA regime:- A double blind,placebo controlled, randomized parallel trial.

PGIMER Chandigarh0 个研究点目标入组 65 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。

•1) Age >= 18 years and < 60 years satisfying presence of axial SpA as per ASAS 2009 criteria.
•2) Peripheral joint involvement <= 1 joint (Currently)
•3) Has received at least one NSAIDs for a total duration of at least 4 weeks and has active disease defined by BASDAI >= 4.
•5) Patient not affording for biologicals like TNF inhibitors or IL-17 inhibitors recommended for treatment of axSpA.
•6) Patients having inadequate response to NSAIDs.
•7)Patient who had inadequate response to prior TNF inhibitors or IL-17 inhibitors, provided they have obtained the last dose one half life before.
•During study period use of NSAID will be on demand as per patient upto maximal dose.
•Patient who are on sulfasalazine or methotrexate for any indication are allowed to continue the same without any change, on stable dose of same for 4 weeks.

•1) Presence of uncontrolled or poorly controlled diabetes defined by HbA1c > 7%.
•2) Presence of any active infection or malignancy.
•3) Recent fracture (within 6months) or hip fracture (ever).
•4) Pregnancy
•5) Have received intra articular or intra muscular steroids less than 4 weeks before.
•6) Uncontrolled hypertension, defined as blood pressure more than systolic 140 and/or diastolic 90, on more than or equal to 3 drugs.
•7) Presence of overt psoriasis or inflammatory bowel disease.

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