| CTRI Number |
CTRI/2018/01/011373 [Registered on: 16/01/2018] Trial Registered Prospectively |
| Last Modified On: |
15/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy and safety of oral vs subcutaneous methotrexate in psoriasis |
|
Scientific Title of Study
|
A randomized controlled trial comparing the efficacy and safety profile of oral versus subcutaneous route of methotrexate administration in moderate to severe psoriasis |
| Trial Acronym |
METOS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tarun Narang |
| Designation |
Assistant Professor |
| Affiliation |
Post graduate Institute of Medical Education and research |
| Address |
Department of Dermatology,
Post graduate Institute of Medical Education and research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9316063166 |
| Fax |
|
| Email |
narangtarun@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tarun Narang |
| Designation |
Assistant Professor |
| Affiliation |
Post graduate Institute of Medical Education and research |
| Address |
Department of Dermatology,
Post graduate Institute of Medical Education and research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9316063166 |
| Fax |
|
| Email |
narangtarun@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tarun Narang |
| Designation |
Assistant Professor |
| Affiliation |
Post graduate Institute of Medical Education and research |
| Address |
Department of Dermatology,
Post graduate Institute of Medical Education and research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9316063166 |
| Fax |
|
| Email |
narangtarun@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh 160012, India. |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Dermatology, Venereology and Leprology. Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh 160012, India.
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Sunil Dogra |
Professor, Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh 160012, India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tarun Narang |
Postgraduate Institute of Medical Education and Research |
Department of Dermatology, Venereologyg and Leprology, Level 5 ROOM No. 5008 AND 5006, New OPD Block, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh 160012, India.
Chandigarh
CHANDIGARH |
9316063166
narangtarun@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh 160012, India. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Psoriasis Vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
oral route of administration of methotrxate |
Psoriasis patients who fulfil the criteria will be randomised to two groups and will receive treatment as per protocol and we will compare the effectiveness of oral versus subcutaneous route of administration of methotrexate in patients with moderate to severe psoriasis by observing the percentage of patients who achieve PASI 90 after 12 weeks of treatment
2) We will also compare the safety profile of oral versus subcutaneous methotrexate.
|
| Comparator Agent |
subcutaneous route of Methotrexate |
Half of the patients will receive methotrexate at a dose of 0.3mg/kg/ week for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged more than 18 years with clinical diagnosis of plaque psoriasis
2)Patients with body surface area involvement > 10 %, PASI >10, |
|
| ExclusionCriteria |
| Details |
1) Hemoglobin < 8 gm/dl ,Total leukocyte count < 3500/ mm3, Platelet count < 100,000/mm3
2) Elevation of hepatic enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST], or γ glutamyl transferase [GGT]) to more than twice the upper limit of normal.
3) Hepatitis, active or recurrent, cirrhosis or excessive current alcohol intake .
4) Use of other hepatotoxic drugs by the patient
5) Positive hepatitis B, hepatitis C or HIV serology
6) Pulmonary or extra-pulmonary active tuberculosis
7) Deranged renal function test.
8) Pregnancy or lactation or if patient is planning to conceive during the treatment period.
9) Patient on other immunosuppressive drugs
10) Recent live vaccination
11) Unreliable patient
12) Patients unwilling for monthly follow-ups.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in the percentage of patients who achieved PASI 90 (90 % reduction in psoriasis area severity score (PASI) compared to baseline) in both the groups |
0 Weeks and 12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in DLQI (dermatology life quality index).
2.Relapse free period after stopping treatment.
3.Adverse events if any.
|
baseline and 12 weeks
Follow up after treatment 6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/02/2018 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
This study is a prospective, double
blinded, randomized, parallel group study to compare the effectiveness and safety profile
of oral versus subcutaneous route of administration of methotrexate in
management of patients with moderate to severe psoriasis. The recruited
patients will be randomized into treatment arms. Randomization will be done
using computer generated random number table.The patients in first treatment
arm will receive 0.3 mg/kg (upto a maximum of 25 mg/week ) of weekly oral methotrexate for 12 weeks or achievement of
PASI 90 whichever is earlier while the
patients in second treatment arm will receive subcutaneous methotrexate
at 0.3 mg/kg/week for the same duration.
The patients will be followed at regular intervals and monitored adequately for
hematological, hepatotoxic and other adverse effects both clinically and
through laboratory investigations according to methotrexate consensus
guidelines during the treatment period. PASI, Body surface area (BSA)
involvement and DLQI will be assessed at each follow up visit and at the end of
12 weeks. The treatment will be tapered at the rate of 5 mg/2 weeks and stopped
after 12 weeks or achievement of PASI 90 whichever is earlier.. Follow ups will
be done at every 2weeks until treatment
completion (12 weeks) and at every 4 weeks till 24 weeks after completion of
treatment.
The primary outcome measures will be
achievement of PASI 90 (90 % reduction in psoriasis area severity score (PASI)
compared to baseline).The secondary outcomes will be improvement in DLQI
(dermatology life quality index), relapse rate and adverse events if any. |