| CTRI Number |
CTRI/2024/05/068034 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing efficacy of oral immunosuppressants in patients with moderate to severe psoriasis |
|
Scientific Title of Study
|
Clinical and Biomarker evaluation of response to oral immunosuppressants in Moderate to Severe 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 |
Surbhi Jain |
| Designation |
Post graduate student |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
CLinical Pharmacology Lab, Department of Pharmacology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Medical college Road, AMU Campus, Civil lines
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9868244832 |
| Fax |
|
| Email |
surbhijain.ge@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Irfan Ahmad Khan |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Chamber of Dr. Irfan Ahmad Khan, Department of Pharmacology,Jawaharlal Nehru Medical College, Aligarh Muslim University, Medical college Road, AMU Campus, Civil lines
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9997448504 |
| Fax |
|
| Email |
irfan1308@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surbhi Jain |
| Designation |
Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
CLinical Pharmacology Lab, Department of Pharmacology,Jawaharlal Nehru Medical College, Aligarh Muslim University, Medical college Road, AMU Campus, Civil lines
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9868244832 |
| Fax |
|
| Email |
surbhijain.ge@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Aligarh Muslim University, Medical College Road, AMU Campus, Civil lines, Aligarh, Uttar Pradesh-202002 |
|
|
Primary Sponsor
|
| Name |
Surbhi Jain Self |
| Address |
Jawaharlal Nehru Medical College, Aligarh Muslim University, Medical College Road, AMU Campus, Civil lines, Aligarh, Uttar Pradesh-202002 |
| 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 |
| Dr Surbhi Jain |
Jawaharlal Nehru Medical College, AMU, Aligarh |
OPD no. 7, Department of Dermatology, Jawaharlal Nehru Medical College, AMU, Aligarh, UP-202002
Aligarh
UTTAR PRADESH |
9868244832
surbhijain.ge@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Regd.), Jawaharlal Nehru Medical College & Hospital, Faculty of Medicine, Aligarh Muslim University, Aligarh U.P. India - 202002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Apremilast |
Apremilast will be given orally in tablet form.
Starter pack -
Day 1: 10 mg in morning, no evening dose.
Day 2: 10 mg morning and evening.
Day 3: 10 mg morning and 20 mg evening.
Day 4: 20 mg morning and evening.
Day 5: 20 mg morning and 30 mg evening.
Day 6 and 7: 30 mg morning and evening.
After the patient completed the starter pack, for maintenance 30 mg tablets will be given per orally twice daily for a period of 12 weeks after assessing the tolerability.
|
| Comparator Agent |
Cyclosporine |
Cyclosporine will be given to the patient orally 2.5 mg/kg twice daily in tablet form.
Dose may be increased by 0.5 mg/kg/day every 2 weeks after 4 weeks of therapy (maximum dose: 4 mg/kg/day).
Once adequate control is achieved, a dose of 2.5 mg/kg/day may be effective for a duration of 12 weeks.
|
| Intervention |
Methotrexate |
15 mg Methotrexate orally in tablet form, once weekly, as a single dose for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed patients with moderate to severe psoriasis
2. Patients aged 18 - 60 years
3. PASI score of ≥ 5 or Body surface area involvement of ≥ 10%
4. Patients providing informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with uncontrolled or major forms of psoriasis which are life threatening
2. Patients on active topical agents
3. Patients taking other systemic drugs for psoriasis in last 2 months
4. Patient taking other drugs which can interfere with Methotrexate or Apremilast or Cyclosporine
5. Patients on biologics within the past 2 weeks
6. Patients with liver or renal impairment or anaemia or thrombocytopenia or leukopenia
7. Patients with hepatitis B, C, HIV or TB infection
8. Patients with a co-existing comorbidity like diabetes mellitus, uncontrolled hypertension and psychiatric illness
9. Pregnant and breastfeeding patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare efficacy of oral Methotrexate versus oral Apremilast versus oral Cyclosporine in moderate to severe psoriasis patients by evaluating changes in Psoriasis Area and Severity Index (PASI) score.
2. To evaluate and compare changes in Biomarkers- cytokines like IL 1, IL 17 and TNF α from baseline associated with pathology of psoriasis treated with oral Methotrexate versus oral Apremilast versus oral Cyclosporine. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare changes in Dermatology Life Quality Index (DLQI) score with oral Methotrexate versus oral Apremilast versus oral Cyclosporine in moderate to severe psoriasis patients.
2. To assess the adverse drug reactions, safety & tolerability of oral Methotrexate versus oral Apremilast versus oral Cyclosporine in moderate to severe psoriasis.
3. To evaluate histological changes after treatment. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
21/06/2024 |
| 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) |
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
|
Moderate to severe psoriasis patients will be enrolled in the
study. After collecting their thorough clinical history and examination at
baseline, they will be allotted one of the treatment groups based on randomization.
Group A will be given oral Methotrexate, Group B will be given oral Apremilast
and Group C will be given oral Cyclosporine. They will be evaluated every 4 weeks
for 12 weeks. Outcome will be assessed via Psoriasis
Area and Severity Index (PASI), Biomarkers of Psoriasis pathology IL 1, IL 17
and TNF-α, Dermatology Life Quality Index (DLQI), Adverse drug reaction (ADR)
and Histopathological changes. |