| CTRI Number |
CTRI/2022/01/039825 [Registered on: 31/01/2022] Trial Registered Prospectively |
| Last Modified On: |
30/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of drug Methotrexate against drugs Methotrexate with Apremilast in Psoriasis disorder |
|
Scientific Title of Study
|
Comparative study of oral Methotrexate vs oral Methotrexate along with Apremilast in patients with Moderate to Severe Chronic Plaque Psoriasis |
| Trial Acronym |
CSOM-MAiP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aanal Patel |
| Designation |
2nd Year Resident Doctor |
| Affiliation |
GMERS Medical College & Civil Hospital, Sola |
| Address |
202, Department of Dermatology, Block A,
GMERS Medical College and Civil Hospital, Sola,
Besides- New Gujarat High Court,
SG Highway,
Ahmedabad. ---Same as Address 1--- Ahmadabad GUJARAT 380060 India |
| Phone |
9712950119 |
| Fax |
|
| Email |
aanal2607@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Krina Patel |
| Designation |
Professor & Head |
| Affiliation |
GMERS Medical College & Civil Hospital, Sola |
| Address |
202, Department of Dermatology, Block A,
GMERS Medical College and Civil Hospital,Sola,
Besides- New Gujarat High Court,
SG Highway,
Ahmedabad. ---Same as Address 1--- Ahmadabad GUJARAT 380060 India |
| Phone |
09227222221 |
| Fax |
|
| Email |
drkbpatel66@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Krina Patel |
| Designation |
Professor & Head |
| Affiliation |
GMERS Medical College & Civil Hospital, Sola |
| Address |
202, Department of Dermatology, Block A,
GMERS Medical College and Civil Hospital, Sola,
Besides- New Gujarat High Court,
SG Highway,
Ahmedabad. ---Same as Address 1--- Ahmadabad GUJARAT 380060 India |
| Phone |
9227222221 |
| Fax |
|
| Email |
drkbpatel66@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMERS Medical College and Civil Hospital, Sola, Ahmedabad. |
|
|
Primary Sponsor
|
| Name |
GMERS Medical College and CIvil Hospital Sola |
| Address |
GMERS Medical College and CIvil Hospital, Sola,
Besides- New Gujarat High Court,
SG highway,
Sola, Ahmedabad |
| 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 Krina Patel |
GMERS Medical College & Civil Hospital-Sola |
202-Skin OPD,
Block A. Ahmadabad GUJARAT |
09227222221
drkbpatel66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMERS Medical College and Civil Hospital, Sola, Ahmedabad. |
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 |
Oral Methotrexate |
If patient fits in Inclusion criteria, Oral Methotrexate(15mg/week) will be given to patient after Randomization with predecided dose. If needed doses can be increased upto max of 22.5mg/week. Drug will be given for 4 months. And patient will be followed up for another 4 months. |
| Intervention |
Oral Methotrexate along with oral Apremilast |
If patient fits in Inclusion criteria, Oral Methotrexate(15mg/kg) along with oral Apremilast( starting from 10 OD increasing upto 30mg BD) will be given to patient after Randomization with predecided dose. If needed doses of Oral Methotrexate can be increased(upto max of 22.5mg/kg) or decreased or stopped. Drug will be given for 4 months. And patient will be followed up for another 4 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients ready to be part of study and sign ICF.
2. Patient presenting with Moderate to Severe Chronic Plaque Psoriasis according to the Rule of Tens (PASI score >10)
|
|
| ExclusionCriteria |
| Details |
1. Patients who failed to give written consent.
2. In patients in which Methotrexate and/or Apremilast is contraindicated
3. Pregnant women and Lactating Mothers
4. Patients with mild disease (PASI <10)
5. Erythrodermic or pustular psoriasis, predominant scalp or nail involvement
6. Patients who have taken methotrexate continuously or intermittently in more than 2.5gm total dose.
7. Patients with hepatic or renal impairment, cardiac dysfunction, blood dyscrasias or any other systemic comorbidity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study the efficacy of oral Methotrexate vs oral Methotrexate with Apremilast in patients with moderate to severe chronic plaque psoriasis
2. To access clinical improvement based on clinical photographs and PASI score
3. To assess the dose requirement of methotrexate in both groups. |
Baseline, then monthly upto 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the DLQI in both the study groups
2. To study the safety profile of study drugs.
|
Baseline, then monthly upto 4 months |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
01/02/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Psoriasis is a chronic inflammatory cutaneous disorder, affecting up to 2%-5% of the world population. The major manifestation of psoriasis is erythematous, scaly patches or plaques on the skin that are occasionally pruritic but have a significant impact on patient’s Quality of Life due to chronicity of the disease and frequent remissions and relapses. Psoriasis is a predominantly a T-cell mediated disorder occurring in genetically susceptible individuals, influenced by environmental factors. Methotrexate is a standard, cheaper drug for psoriasis with excellent efficacy but limited safety profile while Apremilast is a newer molecule with excellent safety profile. Comparing the standard drug alone with addition of newer drug will help in identifying better treatment options for psoriasis in terms of efficacy and safety in a disease which requires long term treatment. Methotrexate acts on cell cycle so have higher side effects like Neutropenia, Bone marrow suppression, Liver fibrosis, etc. Apremilast is a biologic which acts via Cyclic AMP pathway. So it has lesser toxicity and side effects than methotrexate. Apremilast can cause increase URTI, Flu-like symptoms in few patients. Apremilast is out of reach for common people because of its prohibiting cost. But nowadays this drug is not that costly. So adding oral Apremilast in Patients with moderate to severe psoriasis, dose of the Methotrexate can be reduced and can be stopped early and low dose oral Apremilast will be continued for a longer time. Whenever disease exacerbates, we can either increase the dose of oral Apremilast or add oral Methotrexate to control the activity. So over long run cumulative dose of Methotrexate can be reduced and toxicity can be decreased. |