| CTRI Number |
CTRI/2019/04/018854 [Registered on: 30/04/2019] Trial Registered Prospectively |
| Last Modified On: |
26/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the effectiveness of two medicines namely Methotrexate and Apremilast in patients with a skin disease called psoriasis |
|
Scientific Title of Study
|
Comparison of the efficacy of Methotrexate (Mtx) and Apremilast (Apr) in psoriasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjunath Shenoy M |
| Designation |
Professor and Head |
| Affiliation |
Yenepoya Medical College |
| Address |
Department of Dermatology, venereology & leprosy,
Yenepoya medical college
Derlakatte, Manglore -575018
Dakshina Kannada
karnataka, India.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845009976 |
| Fax |
|
| Email |
manjunath576117@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath Shenoy M |
| Designation |
Professor and Head |
| Affiliation |
Yenepoya Medical College |
| Address |
Department of Dermatology, venereology & leprosy,
Yenepoya medical college
Derlakatte, Manglore -575018
Dakshina Kannada
karnataka, India.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845009976 |
| Fax |
|
| Email |
manjunath576117@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjunath Shenoy M |
| Designation |
Professor and Head |
| Affiliation |
Yenepoya Medical College |
| Address |
Department of Dermatology, venereology & leprosy,
Yenepoya medical college
Derlakatte, Manglore -575018
Dakshina Kannada
karnataka, India.
karnataka, India.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845009976 |
| Fax |
|
| Email |
manjunath576117@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College,
Deralakatte, Mangalore - 575018. India. |
|
|
Primary Sponsor
|
| Name |
Yenepoya Medical College |
| Address |
Department of Dermatology, venereology & leprosy,
Yenepoya medical college
Derlakatte, Manglore -575018
Dakshina Kannada |
| Type of Sponsor |
Private 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 Maqbool SAEP |
Yenepoya Medical College Hospital |
Room No 7, Department of Dermatology, Venereology & Leprosy, Yenepoya Medical College, Derlakatte, Mangaluru,575018. India.
Dakshina Kannada
KARNATAKA |
8281141777
mak7891@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 1 |
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 |
Apremilast |
It is a phosphodiesterase 4 inhibitor oral drug approved for the treatment of psoriasis. Apremilast will be given in a dose of 30 mg twice daily orally for 4 months |
| Intervention |
Methotrexate |
An immunosuppressive drug approved for psoriasis. Methotrexate will be given in a dose of 7.5 mg per week orally for 4 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
•All patients visiting the Dermatology OPD diagnosed to have Psoriasis who needs systemic therapy.
•Patients requiring and willing to undergo treatment with Methotrexate or Apremilast
|
|
| ExclusionCriteria |
| Details |
1.Patients who have taken systemic therapy in past three months or topical treatment or phototherapy in past 2 weeks
2.Who are lesser than 18 years of age.
3.Pregnant or those having any serious illness contraindicating systemic therapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Methotrexate and Apremilast |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the side effects of Methotrexate and Apremilast |
4 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/05/2019 |
| 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="4" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study desigin is Quasi experimental study. Primary objective of the study will be to compare the efficacy of Methotrexate and Apremilast in patients with Psoriasis and to compare the adverse effects associated with both the drugs. Patients diagnosed with psoriasis attending the Dermatology OPD in Yenepoya Medical College Hospital, Mangalore will be enrolled for the study. Eligible patients with Psoriasis will be treated with Methotrexate or Apremilast. Outcome will be measured at the end of treatment. Clinical evaluation will be done for every patients.Psoriasis area severity index (PASI) will be calcilated. Blood investigations like complete blood picture, Liver function test will be done in all subjects as required for treatment. Every alternative patient will be put on either Methotrexate or Apremilast. Methotrexate will be given 7.5 mg/week orally with requisite clinical and laboratory monitoring. Weekly monitoring for first month or as required. Apremilast will be given 30 mg BID orally. Initially dose will be titrated from 10 mg/ day with gradually increasing to 30 mg BID over a week. Patient will be evaluated every month for 4 months. Patient is not supposed to use any topical treatment other than emollients during study time.This study will highlight the advantages of the less commonly used drug for treatment of psoriasis. Apremilast does not require frequent monitoring compared to Methotrexate and improves the quality of life in patients.
|