To confirm Safe use and Effectiveness of known Oral drug which is already marketed by name Kenacort® in Patients who are facing joint pain in India

Not Applicable

• Conditions: Health Condition 1: null- Patients with an established diagnosis of Rheumatoid Arthritis

• Registration Number: CTRI/2018/07/015000
• Lead Sponsor: Dr Nilesh Patil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1Patients 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>ii.The mean change in DAS28 (ESR) from baseline to Week 12, post Triamcinolone plus DMARD treatment. <br/ ><br>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. <br/ ><br>Timepoint: Baseline and 12 week

Secondary Outcome Measures

Name	Time	Method
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. <br/ ><br>ii.The mean change in DAS28 (ESR) from baseline to Week 6, post Triamcinolone plus DMARD treatment. <br/ ><br>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. <br/ ><br>Timepoint: 6 week, 12 week and 24 week