| CTRI Number |
CTRI/2023/03/051052 [Registered on: 24/03/2023] Trial Registered Prospectively |
| Last Modified On: |
23/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
METHOTREXATE VERSUS APREMILAST IN THE TREATMENT OF PLAQUE PSORIASIS |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF THE EFFICACY OF METHOTREXATE VERSUS APREMILAST IN THE TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Trish Larissa Miranda |
| Designation |
Junior resident |
| Affiliation |
Mahatma Gandhi Mission Medical College and Hospital,Aurangabad |
| Address |
Department of Dermatology,Venereology and Leprology,OPD number-256,Mahatma Gandhi Mission Medical College and Hospital,N-6 CIDCO,Aurangabad-431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9975083164 |
| Fax |
|
| Email |
larissatrish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Haibatti Pathrikar |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Mission Medical College and Hospital,Aurangabad |
| Address |
Department of Dermatology, Venereology and Leprology,OPD number-256,Mahatma Gandhi Mission Medical College and Hospital,N-6 CIDCO,Aurangabad-431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9527413388 |
| Fax |
|
| Email |
drshilpahaibatti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Trish Larissa Miranda |
| Designation |
Junior resident |
| Affiliation |
Mahatma Gandhi Mission Medical College and Hospital,Aurangabad |
| Address |
Department of Dermatology, Venereology and Leprology,OPD number-256,Mahatma Gandhi Mission Medical College and Hospital,N-6 CIDCO, Aurangabad-431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9975083164 |
| Fax |
|
| Email |
larissatrish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Mission Medical College and Hospital,Aurangabad, Maharashtra,India. |
|
|
Primary Sponsor
|
| Name |
Trish Larissa Miranda |
| Address |
N6 CIDCO,MGM Medical College and Hospital,Aurangabad |
| 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 |
| Trish Larissa Miranda |
Mahatma Gandhi Mission Medical College and Hospital, Aurangabad |
Department of Dermatology,Venereology and Leprology,OPD number-256
Aurangabad
MAHARASHTRA |
9975083164
larissatrish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Mission Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab Apremilast |
Tab Apremilast given as per the protocol mentioned below :-
Day 1-10mg in the morning,
Day 2-10mg in the morning and 10mg at night,
Day 3-10mg in the morning and 20mg at night,
Day 4-20mg in the morning and 20mg at night,
Day 5-20mg in the morning and 30mg at night,
Day 6 and onwards-30mg morning and 30 mg at night |
| Intervention |
Tab Methotrexate 7.5mg weekly in 3 equally divided doses of 2.5mg. |
Tab Methotrexate 7.5mg weekly in 3 equally divided doses given as follows :-
1)Tab Methotrexate 2.5mg Twice a day (on Saturday)
2)Tab Methotrexate 2.5mg once a day (on Sunday)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Male and female patients above 18 years with plaque psoriasis.
2)Involvement of 20% or more of body surface area with plaque psoriasis. |
|
| ExclusionCriteria |
| Details |
1)Pregnancy
2)Lactating women.
3)Immunosuppressed individuals
4)Patients with pustular psoriasis.
5)Patients with erythrodermic psoriasis |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome name-Psoriasis Area Severity Index(PASI) based on the following parameters:-
1. Erythema
2. Induration
3. Desquamation or scaling
|
Week 0-Baseline
Week 4
Week 8
Week 12
Week 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PASI-75-To compare the efficacy of Methotrexate and Apremilast by comparing their PASI-75 scores that is time taken for 75% or more reduction of psoriasis lesions from baseline lesions. |
Not fixed,depending on the time taken to show 75% or more improvement from baseline lesions for each of the 2 drugs separately. |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
30/03/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomised,participant blinded,parallel group,single centre trial to compare the efficacy of Methotrexate and Apremilast in the treatment of moderate to severe plaque psoriasis.In one group of 21 patients ,tablet Methotrexate will be given as 7.5mg weekly in 3 divided doses whereas in the other group of 21 patients, tablet Apremilast will be started at a dose of 10mg and titrated to maximum of 30mg twice daily upto 16 weeks.Assesment will be done by Psoriasis Area severity Index(PASI) score at baseline,week 4, week 8, week 12 and week 16 where PASI 0,PASI 1,PASI2,PASI3 and PASI 4 are calculated respectively.The efficacy of Methotrexate and Apremilast will be compared using PASI 75 that is time taken for 75% or more reduction in psoriasis lesions from baseline lesions. |