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CTRI Number  CTRI/2025/02/080496 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 13/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A study assessing the effect of the drug leucovorin in treating intolerance to methotrexate, a drug used for rheumatoid arthritis 
Scientific Title of Study   A randomised placebo controlled crossover trial of leucovorin for methotrexate intolerance in rheumatoid arthritis 
Trial Acronym  LUMIRA (Leucovorin Use for Methotrexate Intolerance in Rheumatoid Arthritis) 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nuzhah V 
Designation  Junior Resident 
Affiliation  Post Graduate Institute of Medical Education And Research 
Address  Department of Internal Medicine, 4th Floor, F Block, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7356005566  
Fax    
Email  nuzhahnajeeb@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Varun Dhir 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education And Research 
Address  Department of Internal Medicine, 4th Floor, F Block, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  1722756670  
Fax    
Email  varundhir@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nuzhah V 
Designation  Junior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Department of Internal Medicine, 4th Floor, F Block, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7356005566  
Fax    
Email  nuzhahnajeeb@gmail.com  
 
Source of Monetary or Material Support  
Systolic Lab provided medicines 101, Pragati Chambers, Commercial Complex, Ranjit Nagar, New Delhi-110008 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research 
Address  Department of Internal Medicine, 4th Floor, F Block, Nehru Hospital, Post Graduate Institute of Medical Education and Research 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nuzhah V  Post Graduate Institute of Medical Education and Research  Room no 3035 New OPD Block Rheumatology Clinic Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH 		 7356005566

nuzhahnajeeb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Leucovorin  Oral Leucovorin 15 mg will be given 12 hours after last dose of Methotrexate, once a week for 6 weeks 
Comparator Agent  Placebo   Oral Placebo will be given 12 hours after last dose of Methotrexate, once a week for 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The study recruits individuals aged 18 - 60 years, diagnosed with rheumatoid arthritis as per ACR/EULAR 2010 rheumatoid arthritis classification criteria, who are taking Methotrexate at any dose and any form for at least 3 months and have developed severe Methotrexate intolerance (with a Methotrexate intolerance and severity assessment in adults score (MISA) of 6 or more) for at least 1 month. 
 
ExclusionCriteria 
Details  Exclusion criteria include those who are already taking leucovorin, those who have abnormal liver function tests, cytopenias in one or more cell lines, methotrexate induced mucositis and skin rashes/ulcers, and those who are not willing to participate. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the change in MISA score (Methotrexate Intolerance Severity and Assessment in Adults) with and without leucovorin.  At 6 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Disease Activity Score (DAS 28) from baseline, with and without Leucovorin.  At 6 weeks and 12 weeks 
To assess treatment adherence using pill count, with and without leucovorin.  At 6 weeks and 12 weeks 
To assess for patient preference using 5 point Likert scale, on leucovorin versus placebo.  At 6 weeks and 12 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 4 
Date of First Enrollment (India)   24/02/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 is one of the most common autoimmune diseases, which is associated with joint swelling and later on deformities. Many of these patients are positive for rheumatoid factor or anticitrullinated peptide antibody. Methotrexate is the first line treatment for rheumatoid arthritis. However, a substantial proportion of patients (one-third to half) develop intolerance to methotrexate, i.e., they will get unpleasant symptoms on taking methotrexate like nausea, vomiting, headache, feeling lifeless. Many of those who develop intolerance will therefore drop out of treatment with methotrexate. There is some evdence that supplementing folic acid leads to some reduction in methotrexate intolerance. One folate moiety which has been used extensively in methotrexate toxicity is leucovorin (also called folinic acid), which is 5-methyl-folate. However, there is not much evidence on its effect on methotrexate intolerance.
LUMIRA trial will be a double blinded, randomised placebo controlled crossover trial to assess the efficacy of leucovorin 15 mg tablet taken once a week to reduce intolerance to methotrexate.
The study will e carried out on 60 consenting patients of Rheumatoid arthritis who are on methotrexate for attest 3 months and have developed intolerance, i.e, symptoms like nausea, headache etc to it for at least 1 month, with 30 of them receiving intervention medicine, that is leucovorin, in phase 1 of study and the other arm receiving placebo in the phase 1 and after 6 weeks, will be crossed over. There will be no washout period between two phases, as the half life of leucovorin is approximately 6 hours, and will be taken once a week. Patents will be followed up at 6 weeks and 12 weeks, at th end of both phases. We will be comparing the change in MISA (Methotrexate Intolerance Severity and Assessment Score) from baseline at 6 weeks and 12 weeks. The secondary outcomes will include measuring the change in Disease Activity Score (DAS 28), treatment adherence and patient preference with leucovorin versus placebo.
 
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