CTRI/2016/04/006821
Other
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
- Sponsor
- Sun Pharma Laboratories Limited
- Enrollment
- 32
- Status
- Other
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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 μmol/L or 1\.69 mg/dL).
Outcomes
Primary Outcomes
Not specified
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