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A scientific study to know how much the Kenacort Injection is safe and effective in the patients of bone joint health issues.

A Non-Randomized, Double-Arm, Open-Labelled, Multi-Centre, Interventional, Prospective Investigator Initiated Study To Evaluate The Safety And Efficacy Of Intraarticular Triamcinolone Acetonide (Kenacort®) Injection Vs Standard Of Care In Patients With Rheumatoid Arthritis Flare - TRIAD002

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026408
Enrollment
80
Registered
2020-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M069- Rheumatoid arthritis, unspecified

Interventions

Intervention1: Kenacort Injection: The subject will receive- Dose: Triamcinolone Acetonide (KENACORT) Injection of 40 mg Route of Administration: Intraarticular Frequency : one dose through out the

Sponsors

Dr Chandrashekara S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient has a confirmed diagnosis of Rheumatoid Arthritis and on stable therapy for RA in the last 3 months as per ACR 2010 criteria. 2. Evidence of disease flare-up in the knee joint 3. Patient on at least 1 DMARD for the past 6 month 4. Stable dose of DMARD in the last 6 weeks 5. Patients who require intra-articular glucocorticoid injection in the knee joint. 6. Participants should have the ability to understand the requirements of the study. 7. Participants willing to abide by the study restrictions and return for the required assessments. 8. Participants willing to provide an written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients not willing to give informed consent 2. Patients with only mild disease 3. Patients currently on intravenous or depo steroids. 4. In the Principal Investigatorâ??s opinion patient who may require changes in current DMARDs including its dose strength during the study duration. 5. Patients with septic arthritis 6. Any other clinically significant disorder which needs treatment or serious systemic illness 7. Alcoholics and/or drug abusers. 8. Known history of hypersensitivity to the trial drug or any of its ingredients. 9. Pregnant / lactating woman. 10. Patients who have completed participation in any other clinical trial during the past six (06) months. 11. Any other condition which the Principal Investigator thinks may jeopardize the study

Design outcomes

Primary

MeasureTime frame
To assess and compare the mean change in severity of pain measured by VAS score from baseline to week 2 visit. To assess and compare the mean change in reduction of swelling on the Likert scale from baseline to week 2 visit. Timepoint: Week 2

Secondary

MeasureTime frame
To assess and compare the mean change in frequency and duration of morning stiffness from Baseline to Week 6 & Week 12 visit To compare the pattern of frequency morning stiffness between two different arms To assess and compare the mean change in severity of pain & mobility measured by VAS score from Baseline to Week 6 & Week 12 visit To assess and compare the mean change in reduction of swelling on the Likert scale from baseline to week 6 & week 12. Timepoint: week 6 and week 12

Countries

India

Contacts

Public ContactSatish Marukurthi

ChanRe Rheumatology and Immunology Center and Research

chandrashekara_s@yahoo.com9845071151

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026