Health Condition 1: null- Patients with an established diagnosis of Rheumatoid Arthritis
Conditions
Interventions
Intervention1: Triamcinolone: Triamcinolone (Kenacort®) tablets for a period of 12 weeks as per the protocol. All the patients would be initiated with the drug dosage of 8mg of Kenacort® tablets i.e
Sponsors
Dr Nilesh Patil
Abbott Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients willing to participate in the study and sign informed consent form. 2. Patients with a documented history of RA who are on treatment with at least one DMARD for > 6 months and on a stable dose of DMARD(s) for at least 6 weeks 3. Patients with evidence of disease flare up or having insufficient response to DMARD(s) defined as: a.DAS 28 (ESR) >3.2 (moderate disease activity), or b.Swollen joint count of 4 or more out of 28, or c.Tender joint count of 4 or more out of 28
Exclusion criteria
Exclusion criteria: 1. Patients treated with glucocorticoids by any route in the past 6 weeks 2. Patients on more than 3 DMARDs or an additional concomitant biological DMARD 3. Patients having other types of inflammatory arthritis (e.g. lupus) 4. Patients having active infection, including tuberculosis 5. Patients having uncontrolled diabetes or uncontrolled hypertension 6. Pregnant or nursing women 7. Suspected inability or unwillingness to comply with study procedures 8. Known intolerance to any of the ingredients of the formulation 9. Patients under treatment with any medication that may affect the treatment efficacy evaluation. 10. Patients under treatment with any medication whose concomitant use may be susceptible to interactions with triamcinolone or may affect safety 11. Patient having participated in a clinical trial in the last 30 days 12. Any other condition as deemed unfit by the investigator for the patientâ??s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i. Frequency and percentage of patients achieving low disease activity (defined as DAS28 score [DAS(ESR)â?¤ 3.2) at Week 12, post Triamcinolone plus DMARD treatment. ii. The mean change in DAS28 (ESR) from baseline to Week 12, post Triamcinolone plus DMARD treatment. iii. The change in mean severity of morning stiffness (VAS score [mm])and mean duration of morning stiffness (min) from baseline to week 12 post Triamcinolone plus DMARD treatment. Timepoint: Baseline and 12 week | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Frequency and percentage of patients achieving low disease activity (defined as DAS28 score [DAS(ESR)â?¤ 3.2) at Week 6, post Triamcinolone plus DMARD treatment. ii. The mean change in DAS28 (ESR) from baseline to Week 6, post Triamcinolone plus DMARD treatment. iii. The change in mean severity of morning stiffness (VAS score [mm]) and mean duration of morning stiffness (min) from baseline to week 6 post Triamcinolone plus DMARD treatment. Timepoint: 6 week, 12 week and 24 week | — |
Countries
India
Contacts
Public ContactDr Nilesh Patil
Lifepoint Multispecialty Hospital
Outcome results
None listed