| CTRI Number |
CTRI/2025/07/091790 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study safety and efficacy of Methotrexate and Apremilast in the Management of Psoriasis. |
|
Scientific Title of Study
|
To study safety and efficacy of Methotrexate and Apremilast in the Management of Psoriasis: Therapeutic Outcomes and Adverse Effects |
| 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 Ekta Arora |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Pharmacology
Kasna
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7678684969 |
| Fax |
|
| Email |
ektaarora@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saubhagya Gupta |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Pharmacology
Kasna Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8791411004 |
| Fax |
|
| Email |
saubhagyaashu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saubhagya Gupta |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Pharmacology
Kasna Greater Noida
UTTAR PRADESH
201310
India |
| Phone |
8791411004 |
| Fax |
|
| Email |
saubhagyaashu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Sciences (GIMS) Greater Noida |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences (GIMS) Greater Noida |
| Address |
Kasna Greater Noida
Uttar Pradesh
India
pin-201310 |
| 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 Ekta Arora |
Government Institute of Medical Sciences (GIMS) |
Department of Pharmacology
GIMS Academic Block
Gautam Buddha Nagar
UTTAR PRADESH |
7678684969
ektaarora@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee GIMS Greater Noida |
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 |
| Intervention |
Apremilast in treatment of moderate to severe Psoriasis. |
From Baseline to end of treatment and follow-up 16 weeks |
| Comparator Agent |
Methotrexate in the treatment of moderate to severe psoriasis. |
From Baseline to end of treatment and follow-up 16 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults aged more than 18 years of either sex.
2.Clinically and histopathologically confirmed moderate to severe psoriasis based on the Psoriasis Area and Severity Index PASI more than and equal 10 or Body Surface Area BSA more than and equal 10 percent.
3.Candidates for systemic therapy due to inadequate response to topical treatments or phototherapy.
4.Patients who are either treatment-naïve or have not used Methotrexate or Apremilast in the past 6 months
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy & Lactation
2.Severe Co morbidities Any contraindication of starting Methotrexate or Apremilast
3.Use of Methotrexate for indications other than psoriasis
4.Severe Infections: Active tuberculosis, HIV, hepatitis B or C, or other chronic infections
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in PASI (Psoriasis Area and Severity Index) Score
o Difference in PASI score from baseline to 16 weeks.
2.Adverse Effects Profile
o Incidence, severity, and type of adverse drug reactions in each treatment group.
3.Drug Tolerability
o Number of patients who discontinue treatment due to side effects.
4.Laboratory Safety Parameters
o Changes in liver enzymes, renal function, haematological profile during treatment. |
From baseline to end of treatment and follow up to week 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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 3 |
|
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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Research
Design:
Randomized controlled study Research
Setting: Dermatology OPD and Pharmacology department
GIMS Hospital, Greater Noida
Target Population: Patients of moderate -severe psoriasis
visiting Dermatology OPD.
Study Duration: 18
months
Sampling method:
Eligible participants (i.e., patients diagnosed with moderate to severe chronic
psoriasis who meet the inclusion/exclusion criteria) will be enrolled from the
psoriasis clinic at Dept. of dermatology, GIMS, Greater Noida. Once enrolled,
participants will be randomly allocated into two groups (Methotrexate and
Apremilast) using a computer-generated randomization sequence to eliminate
selection bias. Methotrexate Group: The
administration of Methotrexate begins with a test dose of 5 mg. After
administering this test dose, a re-evaluation of CBC (Complete Blood Count),
LFT (Liver Function Test), and KFT (Kidney Function Test) is performed after
one week to assess tolerance and safety. On the 7th day, if the results are
within acceptable limits, Methotrexate therapy is initiated with a dose of 0.3
mg/kg, with a maximum limit of 30 mg per week. The drug is then continued on a
fixed day each week, with once-weekly administration. ³ Apremilast Group: Apremilast dosing
is initiated with a titration schedule to reduce the risk of gastrointestinal
side effects. On Day 1, the patient receives 10 mg once daily. For the next
three days, 10 mg twice daily is administered. Then on Day 5, the dose is
increased to 20 mg once daily, followed by 20 mg twice daily for the next three
days. On Day 9, the patient receives 30 mg once daily, and from Day 10 onwards,
the maintenance dose of 30 mg twice daily is continue |