| CTRI Number |
CTRI/2024/07/069997 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of methotrexate on Thyroid function in Rheumatoid Arthritis Patients of Uttarakhand Region of India |
|
Scientific Title of Study
|
Effect of methotrexate on Thyroid Profile in Rheumatoid Arthritis Patients at a Tertiary care Hospital of Uttarakhand Region of India: A Cross-Sectional Study |
| 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 Mahima Gupta |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Pharmacology, Level 4, building no. 1, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9024850644 |
| Fax |
|
| Email |
mahimag48@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shazia Hasan |
| Designation |
Associate professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
level 4, department of pharmacology, building 1, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9821425949 |
| Fax |
|
| Email |
shazia.phar@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahima Gupta |
| Designation |
Junior resident |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department of Pharmacology, level 4, building no. 1, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09024850644 |
| Fax |
|
| Email |
mahimag48@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Rishikesh, veerbhadra road, Dehradun district, 249203, Uttarakhand , India |
|
|
Primary Sponsor
|
| Name |
Dr Mahima Gupta |
| Address |
Department of Pharmacology, Level 4, Building no. 1, AIIMS Rishikesh |
| Type of Sponsor |
Other [self] |
|
|
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 Mahima Gupta |
AIIMS Rishikesh |
level 4, department of pharmacology, building 1, AIIMS Rishikesh, Virbhadra road, near barrage
Dehradun
UTTARANCHAL |
9024850644
mahimag48@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Rishikesh INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All Patients of RA of age 18 years or more who are managed with methotrexate for ≥ one year |
|
| ExclusionCriteria |
| Details |
Patient already having thyroid disease at the time of diagnosis of rheumatoid arthritis
Pregnant patients
Patient on drugs affecting thyroid function
Patients undergone surgery or radiation around neck area
Patient having any hypothalamo-pituitary disorder/disease
Patients not willing to give consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the proportion of patients with altered thyroid profiles among the patients of Rheumatoid arthritis who were taking methotrexate for ≥ 1 year |
duration of study is 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the association of thyroid profile with different durations of methotrexate use.
To evaluate the association of thyroid profile with different add on drugs in Rheumatoid arthritis management.
To examine the Adverse Drug Reaction arising from anti-rheumatoid drug treatment
|
duration of study is 1 year |
|
|
Target Sample Size
|
Total Sample Size="207"
Sample Size from India="207"
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)
|
20/07/2024 |
| 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="1"
Months="6"
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 arthritis (RA) is an inflammatory joint disease marked by chronic discomfort and joint abnormalities significantly impacting patients’ lives. Key laboratory markers for RA include rheumatoid factor (RF), anti-citrullinated protein antibody (ACPA), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). Treatments typically involve glucocorticoids, NSAIDs, and DMARDs. RA patients are also at a higher risk of thyroid illnesses, such as hypothyroidism and hyperthyroidism, indicating a connection between these conditions. The thyroid, essential for regulating growth and metabolism, plays a significant role in the autoimmune landscape, with thyroid hormones (T3 and T4) and thyroid autoantibodies (TgAb, TPOAb) key factors. Research shows a correlation between thyroid dysfunction and RA, with thyroid hormone levels linked to RA disease activity markers. RA patients with positive thyroid autoantibodies experience greater disease activity and joint damage. However, the impact of RA medications on thyroid function remains unclear, necessitating further exploration of this complex interaction for better management strategies. |