FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/07/026408 [Registered on: 07/07/2020] Trial Registered Prospectively
Last Modified On: 06/11/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A scientific study to know how much the Kenacort Injection is safe and effective in the patients of bone joint health issues.  
Scientific Title of Study   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 
Trial Acronym  TRIAD002 
Secondary IDs if Any  
Secondary ID  Identifier 
TRIAD002 Version 1.0 11 Dec 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chandrashekara S 
Designation  Director 
Affiliation  ChanRe Rheumatology and Immunology Center and Research 
Address  Room No 1 No 65(414) 20th Main 1st Block West of Chord Road Rajaji Nagar Bangalore

Bangalore
KARNATAKA
560010
India 
Phone  9845071151  
Fax  080-42516600  
Email  chandrashekara_s@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandrashekara S 
Designation  Director 
Affiliation  ChanRe Rheumatology and Immunology Center and Research 
Address  Room No 1 No 65(414) 20th Main 1st Block West of Chord Road Rajaji Nagar Bangalore

Bangalore
KARNATAKA
560010
India 
Phone  9845071151  
Fax  080-42516600  
Email  chandrashekara_s@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Satish Marukurthi 
Designation  CEO 
Affiliation  Croissance Clinical Research 
Address  Plot No 37 2nd Floor Matrusri Nagar Gate no 05 Miyapur Hyderabad

Hyderabad
TELANGANA
500049
India 
Phone  9515161468  
Fax    
Email  ceo@croissancecr.com  
 
Source of Monetary or Material Support  
Dr Chandrashekara S (Director Chanre Rheumatology and Immunology Center and Research) Room No 1 No 65(414) 20th Main 1st Block West of Chord Road Rajaji Nagar Bangalore Bangalore KARNATAKA 560010 India  
 
Primary Sponsor  
Name  Dr Chandrashekara S 
Address  Room No 1 Chanre Rheumatology and Immunology Center and Research No 65 20th Main 1st Block West of Chord Road Rajaji Nagar Bengaluru Karnataka  
Type of Sponsor  Other [Principal Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chandrashekara S  ChanRe Rheumatology and Immunology Center and Reserach  Room No.1, No 65 20th Main 1st Block West of Chord Road Rajaji Nagar Bangalore
Bangalore
KARNATAKA 		 9845071151
080-42516600
chandrashekara_s@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chanre Rheumatology and Immunology Center and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kenacort Injection  The subject will receive- Dose: Triamcinolone Acetonide (KENACORT) Injection of 40 mg Route of Administration: Intraarticular Frequency : one dose through out the study Duration of Therapy: 12 weeks 
Comparator Agent  Standard of care  Will receive oral corticosteroids, NSAIDS or IM injection. Other than Triamcinolone and its salts 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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 Investigator’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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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.

 		 Week 2 
 
Secondary Outcome  
Outcome  TimePoints 
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.
 		 week 6 and week 12 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/07/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Rheumatoid arthritis (RA) is a very common chronic inflammatory disease characterized by joint swelling, joint tenderness, and destruction of synovial joints. The prevalence of RA ranges from 0.1–5%. The onset of RA usually occurs between the ages of 30 and 50 years with female preponderance. Incidence of RA in men is estimated to be about 25 per 100,000 persons and for women it is about 54 per 100,000 persons in the United States. RA eventually leads to severe disability and premature mortality.

RA is considered an autoimmune disease. The presence of autoantibodies such as rheumatoid factor (RF) and anti–citrullinated protein antibody (ACPA) precede the clinical manifestation of RA.

Injection of corticosteroids such as Triamcinolone into the synovial joint is now firmly established procedure in the management of rheumatic disease. The RA flare may be suppressed by a single intra-articular injection of corticosteroid when the arthritis involves predominantly one joint.

The goal of directing potent anti-inflammatory treatment into an inflamed joint is the rapid resolution of synovitis. Local treatment may lead to complete resolution of the signs and symptoms of arthritis, thus obviating the need for regular systemic therapy. Also, intra-articular corticosteroid injections helps to avoid adverse effects of systemic corticosteroids.

Currently there is limited data by controlled trials of intra-articular steroids versus systemic agents in any of these contexts. Hence, this study is designed to evaluate the safety and efficacy of Triamcinolone Acetonide (Kenacort®) injection when compared to systemic corticosteroids. Patients with Rheumatoid Arthritis (RA) flare in the knee joint will be evaluated after 12 weeks of an intra-articular injection in the Indian population.

Croissance Clinical Research is supporting Data Management activities for this trial.

 
Close