| CTRI Number |
CTRI/2020/10/028596 [Registered on: 23/10/2020] Trial Registered Prospectively |
| Last Modified On: |
11/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Rapid test for rheumatoid arthritis |
|
Scientific Title of Study
|
Detection of anti-citrullinated albumin antibodies as a point-of-care test for assessment of rheumatoid arthritis |
| Trial Acronym |
Rapid RA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Paturi Vishnupriya Rao |
| Designation |
Co-Investigator |
| Affiliation |
Kumudini Diabetes Research Center |
| Address |
Kumudini Devi Diabetes Research Center,
Ramdevrao Hospital,
Hyderabad
Kumudini Devi Diabetes Research Center,
Ramdevrao Hospital,
Hyderabad
Hyderabad
TELANGANA
500072
India |
| Phone |
9885051110 |
| Fax |
|
| Email |
Diabetes@DiaBaid.IN |
|
Details of Contact Person
Scientific Query
|
| Name |
Paturi Vishnupriya Rao |
| Designation |
Co-Investigator |
| Affiliation |
Kumudini Diabetes Research Center |
| Address |
Kumudini Devi Diabetes Research Center,
Ramdevrao Hospital,
Hyderabad
Kumudini Devi Diabetes Research Center,
Ramdevrao Hospital,
Hyderabad
TELANGANA
500072
India |
| Phone |
9885051110 |
| Fax |
|
| Email |
Diabetes@DiaBaid.IN |
|
Details of Contact Person
Public Query
|
| Name |
Paturi Vishnupriya Rao |
| Designation |
Co-Investigator |
| Affiliation |
Kumudini Diabetes Research Center |
| Address |
Kumudini Devi Diabetes Research Center,
Ramdevrao Hospital,
Hyderabad
Kumudini Devi Diabetes Research Center,
Ramdevrao Hospital,
Hyderabad
TELANGANA
500072
India |
| Phone |
9885051110 |
| Fax |
|
| Email |
Diabetes@DiaBaid.IN |
|
|
Source of Monetary or Material Support
|
| Diabetes Research Society |
|
|
Primary Sponsor
|
| Name |
Diabetes Research Society |
| Address |
6-3-349/17 Panjagutta,
Hyderabad |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DiabetOmics Medical |
6-3-349/31 Panjagutta,
Hyderabad 500 082 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Paturi Vishnupriya Rao |
Kumudini Devi Diabetes Research Center |
Room 18 Ground Floor,
Outpatient Clinics,
Ramdevrao Hospital,
Hyderabad
Hyderabad
TELANGANA |
9885051110
diabetes@diabaid.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ramdevrao Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. 18 years or older, male and female
2. Subjects confirmed, suspected or with symptoms of Rheumatoid Arthritis
3. Smoking or non-smoking
4. Subjects willing for participating in the study and providing informed consent
|
|
| ExclusionCriteria |
| Details |
1. Subjects unwilling to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The expected Outcomes are:
1. Significant positive correlation between presence or absence of (blood and salivary) IgG antibodies (against citrullinated albumin) and, severity and duration of disease after onset of symptoms.
2. Positive association in individuals who have specific disease (RA with elevated ACCP/ACPA or RF) and then antibodies remain detrimental for the remainder of the disease period, warranting more frequent and regular monitoring for anti-cit Alb antibodies. |
first visit only,
cross-sectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The expected secondary study outcomes are:
1. Direct relation between presence of antibodies in blood and oral fluid.
2. IgG antibodies in blood are comparably expressed and demonstrated in oral fluid (GCF) |
first visit only,
cross-sectional study |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/10/2020 |
| Date of Study Completion (India) |
01/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
doi.org/10.1101/2021.06.28.21259657
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Project title
Detection of anti-citrullinated albumin antibodies as a point-of-care test for assessment of rheumatoid arthritis. Summary
The objective of this proposal is to validate a rapid, non-invasive, point-of-care (POC) test for anti-citrullinated albumin (anti-cit Alb) antibodies in serum and gingival crevicular fluid (GCF) for diagnosis of Rheumatoid Arthritis (RA).
The use of such simple-to-use, low-cost and non-invasive POC tests in serum and oral fluid would eliminate the complexity, discomfort, biohazards, and phlebotomy costs of blood tests, and to even further expand health access to rural populations.
This is a prospective, single-center, observational study for citrullinated albumin (cit-Alb) specific IgG antibodies in biological fluids, in serum and collected non-invasively in oral fluid, in RA disease.
For serum and oral fluid (GCF) validation and POC test performance for anti-cit Alb serology, these test reports are compared distinctly in people with and without RA disease as confirmed by anti-cyclic-citrullinated peptide/protein antibody (ACCP/ACPA, ACPA) and / or rheumatoid factor (RA) tests measured in accredited reference laboratories.
A single blood sample and another oral fluid (GCF) sample are collected from 50 test subjects with sero-negative (SN) or sero-positive (SP) RA receiving specific medications for RA, and from about 50 controls without clinical and biochemical parameters suggestive of RA.
Tests for significance of a relationship between POC and laboratory test reports, and between serum and salivary anti-cit Alb antibodies measured in POC devices, are analysed via parametric and non-parametric correlation coefficients.
Investigators hypothesize that there is a direct association between serum and salivary antibodies, as anti-cit Alb IgG antibodies in serum are comparably expressed in oral fluid. It is also hypothesized that there is a positive association between presence and absence of (serum and salivary) IgG antibodies against cit-Alb and, severity and duration of disease. |