Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: Prednisone MR tablets 5mg
: Once daily at bedtime (at about 10 pm), with or after evening meal for 4 weeks. Prednisone MR to be taken with a light meal or snacks if more than 2 to 3 hou
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion 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
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). 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Variables: â?¢Average duration of Morning stiffness (in minutes) (in last 3 days including visit day) â?¢Pain intensity score (in last 3 days including visit day) Timepoint: Day 0 to Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Variables: â?¢Tender joint count (0-28) â?¢Swollen joint count (0-28) â?¢Disease activity score (DAS28) â?¢Health assessment questionnaire disability index (HAQ-DI) â?¢FACIT fatigue score (FACIT-F) â?¢Simplified disease activity index(SDAI) Safety Variables: â?¢Treatment Emergent AEs (Adverse Events) / monitoring of AEs and SAEâ??s throughout the study period. Timepoint: Day 0 to Week 4 Day 0 to week 6 | — |
Countries
India
Contacts
Public ContactGuruprasad Palekar
Sun Pharma Laboratories Limited
Outcome results
None listed