| CTRI Number |
CTRI/2025/05/087115 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
15/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Safety and Effectiveness of Methotrexate Alone vs. Methotrexate with Apremilast in Treating Moderate to Severe Psoriasis |
|
Scientific Title of Study
|
To compare efficacy and safety of methotrexate monotherapy with combination of methotrexate and apremilast using standard doses in moderate to severe chronic plaque psoriasis |
| 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 Akanksha |
| Designation |
Junior resident |
| Affiliation |
Dr RPGMC Tanda |
| Address |
Department of Dermatology venreology and leprosy OPD 7
Dr RPGMC Tanda Kangra
Himachal pradesh
DR RPGMC Tanda hospital district Kangra, Himachal pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7807715951 |
| Fax |
|
| Email |
akanksha200077@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof KS Mehta |
| Designation |
HOD |
| Affiliation |
Department of DVL, Dr RPGMC Tanda |
| Address |
Department of DVL
Dr RPGMC Tanda
Kangra
Himachal pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418457647 |
| Fax |
|
| Email |
hoddermatologytanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha |
| Designation |
Junior resident |
| Affiliation |
Dr RPGMC tanda |
| Address |
Department of Dermatology venreology and leprosy OPD 7
Dr RPGMC Tanda Kangra Himachal pradesh
DR RPGMC Tanda hospital district Kangra, Himachal pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7807715951 |
| Fax |
|
| Email |
akanksha200077@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology, venreology and leprosy
OPD 7
Dr RPGMC Tanda
Kangra , Himachal Pradesh, India PIN code 176001 |
|
|
Primary Sponsor
|
| Name |
Dr RPGMC Tanda |
| Address |
Department of Dermatology, venreology and leprosy OPD 7
Dr RPGMC Tanda Kangra , Himachal Pradesh, India PIN code 176001 |
| 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 Akanksha |
Dr. Rajendra Prasad Government Medical College |
Department of Dermatology venreology and leprosy
Room no 135 OPD 7
Kangra
HIMACHAL PRADESH |
07807715951
akanksha200077@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Rajendra Prasad Government Medical College (Dr. RPGMC) Kangra at Tanda, Himachal Pradesh, India - 176 001 Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A will be given oral methotrexate and folic acid |
Oral methotrexate 0.3mg/kg once a week per oral with Folic acid (5mg) supplementation to be given 5 day/week for 13 weeks |
| Comparator Agent |
Group B will be given oral methotrexate with apremilast and folic acid |
Oral methotrexate 0.3mg/kg once a week per oral and Apremilast 30 mg twice daily orally after starter pack with Folic acid (5mg) supplementation to be given 5 day/week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients having moderate to severe chronic plaque psoriasis with more than 3 percent of body surface area involved by psoriasis with or without psoriatic arthritis.
2. Patients having moderate to severe chronic plaque psoriasis (defined by a score of at least 3 on the Psoriasis Area and Severity Index (PASI).
3. Patients of psoriasis not on any form of systemic antipsoriatic treatment for at least 4 weeks and or topical treatment for at least 2 weeks prior to the initiation of therapy. |
|
| ExclusionCriteria |
| Details |
1. Patients less than 18 years of age.
2. Pregnant and or lactating females.
3. Patients noncompliant with an effective regimen of contraception
4. Patients having hepatic or renal impairment, deranged lipid profile. Hematologic impairment, any acute infection requiring antimicrobial therapy. Uncontrolled hypertension or diabetes mellitus, with BMI more than 30, or known psychiatric illness.
5. Patients having a history of cancer, including skin cancer or hematologic, cerebral or pulmonary neoplasia.
6. Patients who are alcoholic or have a long history of alcohol intake. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Grade of improvement by reduction of PASI score |
It will be determined initially at baseline, end of first week, then every two weekly for next four weeks and then every four weekly during the next two months thereafter. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Side effects related to treatment |
After each visit |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/05/2025 |
| 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 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
|
This is a comparative study that intends to study the efficacy and safety of methotrexate monotherapy with combination of methotrexate and apremilast in patients of moderate to severe chronic plaque psoriasis. Patients will be selected based on the eligibility criteria. After obtaining consent detailed history and thorough clinical examination will be performed. They will undergo clinical examination, measurement of weight, blood pressure and blood investigations at each visit. Patients will be given methotrexate alone or combination of methotrexate and apremilast on alternate basis. PASI score will be measured, side effects relevant to the treatment shall be evaluated on every visit. Patients will be followed up till 13 weeks. |