| CTRI Number |
CTRI/2023/12/060765 [Registered on: 26/12/2023] Trial Registered Prospectively |
| Last Modified On: |
16/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation between Anti CCP autoantibody concentration and severity of Rheumatoid arthritis (Sandhiva) |
|
Scientific Title of Study
|
Correlation between Anti Cyclic citrulinated peptide (Anti-CCP)antibody titre and disease severity in Rheumatoid Arthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Chaudhary |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences Rajkot |
| Address |
Department of Microbiology
All India Institute of Medical Sciences
Village Khandheri
Taluka Paddhari
District Rajkot 360110
Rajkot
GUJARAT
360001
India |
| Phone |
9016579950 |
| Fax |
|
| Email |
acdranil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Chaudhary |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences Rajkot |
| Address |
Department of Microbiology
All India Institute of Medical Sciences
Village Khandheri
Taluka Paddhari
District Rajkot 360110
GUJARAT
360001
India |
| Phone |
9016579950 |
| Fax |
|
| Email |
acdranil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Chaudhary |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences Rajkot |
| Address |
Department of Microbiology
All India Institute of Medical Sciences
Village Khandheri
Taluka Paddhari
District Rajkot 360110
GUJARAT
360001
India |
| Phone |
9016579950 |
| Fax |
|
| Email |
acdranil@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of Mediacal Sciences Rajkot |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rajkot |
| Address |
Village Khandheri Taluka Paddhari District Rajkot.
Pin 360110 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Chaudhary |
All India institute of Medical Sciences Rajkot |
Microbiology, Medicine & Orthopedic department
All India Institute of Medical Sciences
Village Khandheri
Taluka Paddhari
District Rajkot 360110
Rajkot
GUJARAT |
9016579950
acdranil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years of age
Patients having Rheumatoid Arthritis according to ACR EULAR 2010 crteria |
|
| ExclusionCriteria |
| Details |
Patient less than 18 years
Pregnant and lactating female
Those not giving valid consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate the titre anf anti CCP antibodies with the disease severity in patients with Rheumatoid arthritis |
1 year 9 month data collection
3 months data analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Which test is better associated with severity, Rheumatoid factor or Anti CCP antibodies? |
2 years |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
01/01/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rheumatoid Athritis (RA) is a common immunological disorder with global prevalence of 0.25– 1%. . The disease course is variable ranging from mild disease to severe disability. The mainstay of management in RA is Disease Modifying Anti Rheumatic Drugs (DMARDS). Early detection of disease activity helps in starting the treatment at earliest and also helps in directing aggressive therapy to severe disease, this helps in slowing the disease progression. Laboratory diagnosis of Rheumatoid arthritis is mainly done by detecting the level Rheumatoid factor in blood which has high sensitivity but low specificity. Citrullination of synovial antigens, especially fibrin, is an active process during synovial inflammation that probably allows the induction of anti-cyclic citrullinated peptide (anti-CCP) antibody in RA patients. Measurement of this Anti-CCP antibody in patient’s serum is diagnostic modality for RA with high specificity compared to RA factor. This study is intended to find the correlation between Anti –CCP antibody and disease activity in Rheumatoid arthritis. |