Evaluation of efficacy and safety of a modified release glucocorticoid in the treatment of moderate to severe active rheumatoid arthritis accompanied by morning stiffness: a randomized, double blind, double dummy, comparative, multi-center study. - NA

Sun Pharma Laboratories Limited0 个研究点目标入组 32 人开始时间: 待定最近更新: 2021年11月24日

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•Patients must meet all of the following criteria to be considered for enrollment in the study:
•1.Male or female patient aged between 18 and 70 years.
•2.Patients have documented history of RA in agreement with ACR criteria.
•3.Patients on DMARD treatment for RA for at least 3 months before the study with a stable dose for at least 1 month before screening visit.
•4.Patients have average daily duration of morning stiffness greater than or equal to 45 minute in last three days including screening visit day.
•5.Patients have one or more swollen joints (out of 28).
•6.Patients have 3 or more tender joints (out of 28).
•7.Patients have ESR >= 28 mm/hr.
•8.Patients with presence of pain as derived from visual analogue scale (VAS) at the time of screening.
•9.Patients willing to give their written consent in Informed Consent Form.

•Patients meeting any of the following criteria must be excluded from enrollment in the study:
•1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
•2.Patients suffering from another disease, which requires glucocorticoid treatment during the study period.
•3.Patients who are on DMARD treatment other than Methotrexate and Hydroxychloroquine.
•4.Patients have under gone synovectomy within 4 months prior to study initiation.
•5.Patients have continued use of systemic glucocorticoids within 4 weeks prior to screening visit.
•6.Patients have intermittent/ irregular use of glucocorticoids within 2 weeks prior to screening visit.
•7.Patients have joint injections within 6 weeks prior to screening visit.
•8.Patients who are on topical glucocorticoids and donâ??t agree to stop at screening visit.
•9.Patients with substantial renal impairment (Serum creatinine >150 Î¼mol/L or 1.69 mg/dL).
•10.Patient with substantial hepatic impairment.
•11.Patient has used Biological drugs within 4 month before screening visit.
•12.Patients who using any contra-indicated drug for glucocorticoids.

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