| CTRI Number |
CTRI/2021/07/035307 [Registered on: 30/07/2021] Trial Registered Prospectively |
| Last Modified On: |
25/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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To understand the immunogenicity of Covisheild vaccine in patients with rheumatological disease by discontinuing methotrexate temporarily after taking second dose of vaccine |
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Scientific Title of Study
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Effect Of Discontinuation of Methotrexate, post 2nd dose on Immunogenicity Of ChAdOx1 nCoV -19 Corona Virus (COVISHIELD)Vaccination in Patients With Autoimmune Rheumatic diseases who continued their Methotrexate doses after 1st dose : A Single Centre Randomized Clinical Trial
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| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Padmanabha Shenoy D |
| Designation |
Consultant Rheumatologist |
| Affiliation |
Dr Shenoys Care Private Limited |
| Address |
Centre for Arthritis and Rheumatism Excellence ( CARE),
2nd floor Rheumatology
16/554-2, NH 47,
Nettoor, Cochin
Centre for Arthritis and Rheumatism Excellence ( CARE),
2nd floor Rheumatology 16/554-2, NH 47,
Nettoor, Cochin
Ernakulam
KERALA
682040
India |
| Phone |
9446567000 |
| Fax |
|
| Email |
drdpshenoy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padmanabha Shenoy D |
| Designation |
Consultant Rheumatologist |
| Affiliation |
Dr Shenoys Care Private Limited |
| Address |
Centre for Arthritis and Rheumatism Excellence ( CARE),
2nd floor Rheumatology
16/554-2, NH 47,
Nettoor, Cochin
Centre for Arthritis and Rheumatism Excellence ( CARE),
2nd floor Rheumatology 16/554-2, NH 47,
Nettoor, Cochin
Ernakulam
KERALA
682040
India |
| Phone |
9446567000 |
| Fax |
|
| Email |
drdpshenoy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RASHWITH U |
| Designation |
DrNB Clinical Immunology and Rheumatology 1ST year trainee |
| Affiliation |
Dr Shenoys Care Private Limited |
| Address |
SreeSudheenderaMedical Mission Hospital
Kacheripady, Chittoor Road,
Ernakulam
Kochi
Centre for Arthritis and Rheumatism Excellence ( CARE), 16/554-2, NH 47,
Nettoor, Cochin
Ernakulam
KERALA
682018
India |
| Phone |
|
| Fax |
|
| Email |
yogeshumesh3@gmail.com |
|
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Source of Monetary or Material Support
|
| Centre for Arthritis and Rheumatism Excellence ( CARE), |
|
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Primary Sponsor
|
| Name |
Centre for Arthritis and Rheumatism Excellence CARE |
| Address |
Centre for Arthritis and Rheumatism Excellence ( CARE),
16/554-2, NH 47, Nettoor,
Cochin-682040, State:Kerala(32),
|
| Type of Sponsor |
Private hospital/clinic |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Padmanabha Shenoy D |
Dr Shenoy’s Care Private Limited |
Centre for Arthritis and Rheumatism Excellence ( CARE),
2nd floor Rheumatology
16/554-2, NH 47, Nettoor,
Cochin-682040, State:Kerala(32),
Ernakulam
KERALA |
9446567000
drdpshenoy@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SreeSudheendra Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M061||Adult-onset Stills disease, (2) ICD-10 Condition: M45||Ankylosing spondylitis, (3) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (4) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (5) ICD-10 Condition: M315||Giant cell arteritis with polymyalgia rheumatica, (6) ICD-10 Condition: M06||Other rheumatoid arthritis, (7) ICD-10 Condition: M058||Other rheumatoid arthritis with rheumatoid factor, (8) ICD-10 Condition: M36||Systemic disorders of connective tissue in diseases classified elsewhere, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Methotrexate - as oral or IV from 2.5 to 30 mg |
The patients with AIRD randomized to other group which continue Methotrexate temporarily for 2 weeks post 2nd dose of Covisheild vaccine |
| Intervention |
Methotrexate - as oral or IV form 2.5 to 30 mg |
The patients with AIRD randomized to other group which discontinue Methotrexate temporarily for 2 weeks post 2nd dose of Covisheild vaccine |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
Patient above 18 years of age.
Patients willing to give consent for the study
Patients with a prior diagnosis of Autoimmune Rheumatic Disease and on methotrexate ,
stable dose for atleast the past 2 months
|
|
| ExclusionCriteria |
| Details |
Patients who had covid-19 infection in the past.
Patients who are not willing for blood sample collection.
Patients with h/o allergy to vaccine components Prior GBS/demyelinating syndromes
Any live vaccine taken within prior 4 weeks or inactivated vaccine in last 2 weeks before study. |
|
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Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
To compare the immunogenicity of Covishield vaccination in patients with Auto immune Rheumatic Diseases on methotrexate discontinuation temporarily for 2 weeks after second dose of vaccine versus those who continued methotrexate, in patients who continued their methotrexate doses after 1st dose.
To see the effect of short term discontinuation of Methotrexate on AIRD disease activity. |
To compare the immunogenicity of Covishield vaccination in patients with Auto immune Rheumatic Diseases on methotrexate discontinuation temporarily for 2 weeks after second dose of vaccine versus those who continued methotrexate, in patients who continued their methotrexate doses after 1st dose. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
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Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
04/07/2022 |
| 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="6"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
EffectOf Discontinuationof Methotrexate,post 2nd dose on Immunogenicity Of ChAdOx1 nCoV -19 Corona Virus (COVISHIELD)Vaccination in Patients With Autoimmune Rheumatic diseases who continued their Methotrexate doses after 1st dose : A Single Centre Randomized Clinical Trial OBJECTIVE: To investigate
whether temporary discontinuation of Methotrexate
(MTX) for 2 week a fter second dose of Covishield vaccination improves the immunogenicity in patients with Autoimmune Rheumatic diseases
who have continued Methotrexate after 1st dose.
we study the effect of
temporary discontinuation of MTX for 2 weeks post Covishield
vaccine doses on the humoral and cellular immunogenicity at the end of 1
month post 2nd dose of vaccination.
.Objective ·
To investigate whether temporary
discontinuation of Methotrexate for 2 weeks after 2nd dose of
covishield vaccination improves the immunogenicity in patients with AIRD who
had continued their Methotrexate doses after 1st dose.
·
To see the effect of short term
discontinuation of Methotrexate on AIRD disease activity.
Outcomes
·
The anti spike/neutralising
antibody titrewill be assessed1 month
after the second dose of vaccine, and will be compared between 2 groups who
continued methotrexate after 2nd dose and other group who
discontinued Methotrexate for 2 weeks post 2nd doseand to see if
there is statistically significant difference among the two groups studied.
·
Any significant
change in disease activity associated with discontinuation of methotrexate for
2 weeks will be noted.
.Reference 1.Singh JA, Saag
KG, Bridges SL Jr et al (2016) 2015 American College of Rheumatology Guideline
for the treatment of rheumatoid arthritis. Arthritis Rheum 68(1):1–26
2.Smolen JS, Landewe R, Breedveld FC et
al (2014) EULAR recommendations for the management of rheumatoid arthritis with
synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann
Rheum Dis 73(3):492–509 3.Impact of temporary methotrexate
discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with
rheumatoid arthritis: a randomised clinical trial Park JK, et al. Ann Rheum Dis
2018;77:898–904. doi:10.1136/annrheumdis-2018-213222 4. Doran MF,
Crowson CS, Pond GR, et al. Frequency of infection in patients with rheumatoid
arthritis compared with controls: a population-based study. Arthritis Rheum
2002;46:2287–93. 2 Au K, Reed G, Curtis JR, et al. High disease activity is
associated with an increased risk of infection in patients with rheumatoid
arthritis. Ann Rheum Dis 2011;70:785–91. 5.Akkara Veetil
BM, Bongartz T (2011) Perioperative care for patients with rheumatic diseases.
Nat Rev Rheumatol 8(1):32–41 6.Tada M, Inui
K, Sugioka Y, Mamoto K, Okano T, Kinoshita T, Hidaka N, Koike T (2016) Delayed
wound healing and postoperative surgical site infections in patients with
rheumatoid arthritis treated with or without biological disease-modifying
antirheumatic drugs. ClinRheumatol 35(6):1475–1481 7.Park JK,
et al. Ann Rheum Dis 2018;77:898–904 8.Nived et al | 9. Effect of
short-term methotrexate discontinuation on rheumatoid arthritis disease
activity: post-hoc analysis of two randomized trials JinKyun Park1 & Min
Jung Kim1 &Yunhee Choi2 & Kevin Winthrop3 &YeongWook Song1 &Eun
Bong Lee1 10.Methotrexate
Hampers Immunogenicity to BNT162b2 mRNA COVID-19 Vaccine in Immune-Mediated
Inflammatory DiseaseRebecca H. Haberman et al 11 .Methotrexate and glucocorticoids
, but not anticytokine therapy, impair the immunogenicity of a single dose of the BNT162b2 mRNA
COVID19 vaccine in patients with chronic inflammatory arthritis.Serena
Bugatti et al 12 .The effect of methotrexate and
targeted immunosuppression on humoral and cellular immune
responses to the COVID 19 vaccine
BNT162b2: a cohort study, Satveer k Mahil et al .
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