| CTRI Number |
CTRI/2019/02/017579 [Registered on: 11/02/2019] Trial Registered Prospectively |
| Last Modified On: |
10/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
An Observational Study To compare oral apremilast to oral methotrexate in
psoriasis patients. |
|
Scientific Title of Study
|
Apremilast versus Methotrexate In Moderate To Severe
Psoriasis : A Comparative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr H Anchitha |
| Designation |
Post Graduate |
| Affiliation |
Kasturba medical college ,Mangalore |
| Address |
Dept of Dermatology, OPD No. 10,First floor ,KMC HOSPITAL,ATTAVAR,Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9449055001 |
| Fax |
|
| Email |
h.anchitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kashinath Nayak |
| Designation |
Associate Professor, |
| Affiliation |
Kasturba medical college ,Mangalore |
| Address |
Department of Dermatology,Dermatology OPD Room no 16 ,First floor,KMC HOSPITAL,Ambedkar Circle, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880206799 |
| Fax |
|
| Email |
kashi.nayak@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr H Anchitha |
| Designation |
Post Graduate |
| Affiliation |
Kasturba medical college ,Mangalore |
| Address |
Dept of Dermatology, OPD No. 10,First floor ,KMC HOSPITAL,ATTAVAR,Mangalore
Dakshina Kannada
KARNATAKA
575001.
India |
| Phone |
9449055001 |
| Fax |
|
| Email |
h.anchitha@gmail.com |
|
|
Source of Monetary or Material Support
|
| KASTURBA MEDICAL COLLEGE,MANGALORE |
|
|
Primary Sponsor
|
| Name |
DR H ANCHTIHA |
| Address |
KASTURBA MEDICAL COLLEGE,
LIGHT HOUSE HILL ROAD,MANGALORE 575001
DAKSHINA KANNADA,
KARNATAKA. |
| 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 H ANCHITHA |
KMC HOSPITAL AND HOSPITALS ATTACTHED TO IT |
1)Dermatology OPD No. 10,First floor ,KMC HOSPITAL,ATTAVAR,Mangalore – 575001
2)Dermatology OPD No. 35, First floor,GOVT WENLOCK HOSPITAL,MANGALORE 575001.
3)Dermatology OPD Room no 16 ,First floor,KMC HOSPITAL,Ambedkar Circle, Mangalore – 575001
Dakshina Kannada
KARNATAKA |
9449055001
h.anchitha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College, Mangalore |
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 Apremilast 30mg (BD) |
Oral Apremilast 30mg administered 1 tablet twice daily for 16 weeks |
| Comparator Agent |
Oral Methotrexate |
Oral Methotrexate 5mg-15mg/week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of moderate to severe plaque psoriasis defined by
BSA > 10 or PASI > 10 or DLQI >10
2. Patients who are candidates for systemic therapy for psoriasis
3. Inadequate response to a previous systemic treatment
4. In good health as judged based on medical history, physical examination, serum chemistry labs, haematology values, and urinalysis.
5. Subjects are competent to sign and give informed consent
6. Subjects who willing to adhere to the Protocol and visit schedule.
|
|
| ExclusionCriteria |
| Details |
1.Patients with non-plaque forms of psoriasis (erythrodermic, guttate, pustular)
2.Pregnant or lactating women
3.Patients who had received any systemic treatment for psoriasis within 4 weeks of the baseline visit and topical treatment within the past 2 weeks of the baseline visit .
4.Phototherapy ultraviolet A with psoralen [PUVA] within 4 weeks of the baseline visit and/or ultraviolet B (UVB) within 2 weeks of the baseline visit
5.History of serious hypersensitivity to phosphodiesterase type 4 (PDE-4) inhibitors
6.Subjects with history of suicidal thought or other clinically significant psychiatric diseases
7.History of k/c/o congenital or acquired immunodeficiencies -HIV,Malignancy,Hepatitis B or C and other severe infection
8.Subject history of active tuberculosis infection or incompletely treated active or latent tuberculosis infection
9.Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50 and PASI 75
2)Changes in body surface area (BSA)
3)Change from baseline in the disease activity scores in terms of PASI |
16 weeks after initiation of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)Changes in static physician global assessment (sPGA) |
At baseline and at 16weeks |
2)Proportion of patients with Dermatology Life Quality Index (DLQI) ≤5
3)Rate of discontinuation of treatment
4)Reasons for discontinuation
|
16 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
14/02/2019 |
| 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="2"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AIM: To compare and evaluate the efficacy, safety and compliance of oral apremilast to oral methotrexate in moderate to severe plaque psoriasis patients. OBJECTIVES: To compare and evaluate the clinical efficacy of oral apremilast to oral methotrexate in psoriasis To evaluate the clinical safety and adverse effect of both the drugs To assess tolerability and patient compliance to the both the drugs
STUDY SETTING: Teaching hospitals attached to the Medical College this study is conducted in. STUDY DESIGN: Prospective , Non-interventional, Observational, Comparative study
DATA COLLECTION AND METHODOLOGY Patients who fit the inclusion criteria are approached and informed regarding the nature and purpose of study. Those who are voluntarily willing to participate in the study will be enrolled. Written informed consent will be taken. As this study is non-interventional, drug dosing and treatment duration will be at the sole discretion of the treating dermatologist, in accordance with daily clinical practice. Moderate to Severe Plaque psoriasis patient who fit the inclusion criteria and who are started either on oral apremilast 30mg (BD) or oral methotrexate 5mg-15mg/week are considered for the study. -Baseline demographics, disease characteristics and medication history prior to the start of treatment will be collected. -Complete Blood Count(CBC),Liver Function Test (LFT) and Renal Function (RFT),Chest Xray and Urine analysis will be done on Day 0 -CBC and LFT will be repeated on completion of week 1,4,8 and 16 from the initiation of treatment. -Patient will followed up for a duration of 16 weeks from treatment.
Outcome Variables: Skin-specific disease
measures25 will be assessed on baseline visit and during scheduled
follow ups -Psoriasis
Activity and Severity Index (PASI) -Physician
Global Assessment (sPGA)
-Body
Surface Area (BSA) |