| CTRI Number |
CTRI/2025/07/091917 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to See if Adding Hydroxychloroquine to Methotrexate Helps Protect the Heart in People with Early Rheumatoid Arthritis |
|
Scientific Title of Study
|
Cardioprotective Benefits of Methotrexate and Hydroxychloroquine
Combination Therapy vs Methotrexate Monotherapy in Early and Low Risk
Rheumatoid Arthritis A Randomized Control 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 Cyrus Paul Isaac |
| Designation |
Post Graduate, Department of Pharmacology |
| Affiliation |
Shri Atal Bihari Vajpayee Medical College and Research Institute |
| Address |
1, Lady Curzon RD, Shivajinagar, Bengaluru
Bangalore
KARNATAKA
560001
India |
| Phone |
9731045614 |
| Fax |
|
| Email |
cyruspaul500@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nalini G K |
| Designation |
Post Graduate, Department of Pharmacology |
| Affiliation |
Shri Atal Bihari Vajpayee Medical College and Research Institute |
| Address |
1, Lady Curzon RD, Shivajinagar, Bengaluru
1, Lady Curzon RD, Shivajinagar, Bengaluru, Karnataka 560001
KARNATAKA
560001
India |
| Phone |
9343610550 |
| Fax |
|
| Email |
nskarg97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Cyrus Paul Isaac |
| Designation |
Post Graduate, Department of Pharmacology |
| Affiliation |
Shri Atal Bihari Vajpayee Medical College and Research Institute |
| Address |
1, Lady Curzon RD, Shivajinagar, Bengaluru
KARNATAKA
560001
India |
| Phone |
9731045614 |
| Fax |
|
| Email |
cyruspaul500@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Cyrus Paul Isaac |
| Address |
1, Lady Curzon RD, Shivajinagar, Bengaluru, Karnataka 560001 |
| Type of Sponsor |
Government medical college |
|
|
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 Cyrus Paul Isaac |
Bowring and Lady Curzon Hospital |
1, Lady Curzon RD, Shivajinagar, Bengaluru
Bangalore
KARNATAKA |
9731045614
cyruspaul500@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Shri Atal Bihari Vajpayee Medical College & Research Institute |
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
|
| Type |
Name |
Details |
| Intervention |
Methotrexate and Hydroxychloroquine Therapy |
Tablet Methotrexate 7.5mg once a week for 6 months and Tablet Hydroxychloroquine 200mg twice a day daily for 6 months |
| Comparator Agent |
Methotrexate Monotherapy |
Tablet Methotrexate 7.5mg once a week for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically Diagnosed patients with Rheumatoid Arthritis fulfilling the EULAR Criteria
more than 6
2. Early Rheumatoid Arthritis less than 2 years and Low Risk Rheumatoid Arthritis.
DAS28 less than 3.2
3. Adult patients of the age of 18 to 60 years.
4. All Genders.
5. Participants willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and Nursing women.
2. Patients with history of cardiovascular complications like MI, CVA and Heart Blocks and
abnormal ECG changes.
3. Patients using lipid lowering drugs.
4. Patients on medications that can prolong the QT interval.
5. Patients with other autoimmune diseases.
6. Patients with hypertension and diabetes.
7. Impaired renal and liver functions.
8. Patients with joint deformities.
9. Patients with Retinal defects. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the cardioprotective benefits between the two groups. |
1. Baseline
2. 1 Month
3. 3 Months
4. 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and Efficacy of drugs used in both groups. |
1. Baseline
2. 1 Month
3. 3 Months
4. 6 Months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
11/08/2025 |
| 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="8"
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
|
The study aims to study the effect of Methotrexate and Hydroxychloroquine Combination Therapy vs Methotrexate monotherapy and their role as a cardioprotective agent in Early and Low risk rheumatoid arthritis patients. It is a randomized control study. The study will assess changes in CRP, ESR, Lipid Profile and Blood Glucose changes at baseline, 1 month, 3 months and 6 months. A total of 66 patients will be recruited where 33 will be assigned to Group 1 which will receive Methotrexate Monotherapy and 33 will be assigned to Group 2 and will receive Methotrexate and Hydroxychloroquine Combination therapy. Both groups will be followed up and will be monitored for potential cardioprotective changes in the respective groups. The goal is to know whether initiation of combination therapy early in rheumatoid arthritis has any cardioprotective benefits or not. |