CTRI

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CTRI Number

CTRI/2023/06/053496 [Registered on: 02/06/2023] Trial Registered Prospectively

Last Modified On:

05/06/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A randomised trial to find out the better treatment option between a combination of low dose rituximab and low dose prednisolone versus low dose prednisolone alone in inducing repeat remission in pemphigus vulgaris patients who develop disease relapse

Scientific Title of Study

Assessment of efficacy of combination of low dose rituximab & low dose prednisolone vs low dose prednisolone in inducing repeat remission in rituximab treated pemphigus vulgaris patients who develop disease relapse : A randomised controlled trial

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Ishita
Designation	Junior Resident
Affiliation	PGIMER, Chandigarh
Address	Department of Dermatology, Venereology and Leprology PGIMER, Chandigarh 160012 Department of Dermatology, Venereology and Leprology PGIMER, Chandigarh 160012 Chandigarh CHANDIGARH 160012 India
Phone	7042733241
Fax
Email	ishitaanshum@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Dipankar De
Designation	Professor
Affiliation	PGIMER,Chandigarh
Address	Department of Dermatology, Venereology and Leprology PGIMER, Chandigarh 160012 Chandigarh CHANDIGARH 160012 India
Phone	7087009142
Fax
Email	dr_dipankar_de@yahoo.in

Details of Contact Person
Public Query

Name	Dr Ishita
Designation	Junior Resident
Affiliation	PGIMER, Chandigarh
Address	Department of Dermatology, Venereology and Leprology PGIMER, Chandigarh 160012 Department of Dermatology, Venereology and Leprology PGIMER, Chandigarh 160012 Chandigarh CHANDIGARH 160012 India
Phone	7042733241
Fax
Email	ishitaanshum@gmail.com

Source of Monetary or Material Support

PGIMER, CHANDIGARH

Primary Sponsor

Name	PGIMER, Chandigarh
Address	Department of Dermatology, PGIMER, CHANDIGARH
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ishita	PGIMER, Chandigarh	Room no 5007, NEW OPD 5th floor, Department of Dermatology, Venereology and Leprology PGIMER, Chandigarh 160012 Chandigarh CHANDIGARH	7042733241 ishitaanshum@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee(Intramural), PGIMER, Chandigarh	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: L100\|\|Pemphigus vulgaris,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Prednisolone	Oral Low dose prednisolone(0.3mg per kilogram body weight, once daily)
Intervention	Rituximab and prednisolone	Intravenous low dose rituximab (500mg, Single infusion) along with oral low dose prednisolone (0.3 mg per kilogram body weight, once daily)

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1. Patients of PV diagnosed with the following criteria: Compatible clinical picture and positive DIF with IgGÂ±C3 in intercellular pattern in epidermis/ epithelium 2. Patients of PV who had been treated with rituximab (2 doses of 1g each, 2 weeks apart) for induction of immediate preceding remission who have disease relapse defined as â€˜Appearance of 3 or more new lesions in a month that do not heal spontaneously within 1-week in a patient who has achieved clinical remissionâ€™. 3. Relapse duration less than 3 months 4. Patients with PDAI less than or equal to 45 (mild to moderate relapse) 5.Patient of age between 18-70 years. 6.Patients willing to come to PGIMER as per requirement of treatment protocol for follow up.

ExclusionCriteria

Details

1. Refusal to give consent.
2. Pregnant and lactating women.
3. Infections- Hepatitis B, Hepatitis C, HIV, active tuberculosis or sepsis
4. Abnormal liver function tests and renal function tests
5. Known cardiac arrhythmias or conduction abnormalities
6. Women of reproductive age who have not completed their families and are not willing for contraception until 12 months after completion of rituximab infusion.
7. Severely decreased bone marrow function
8. Known hypersensitivity to murine proteins
9. Patients who have known contraindications for oral prednisolone (uncontrolled diabetes, uncontrolled hypertension, peptic ulcer disease, glaucoma, central serous retinopathy, steroid induced psychosis)

Method of Generating Random Sequence

Permuted block randomization, variable

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To find out which of the treatment option between the combination of low dose rituximab & low dose prednisolone versus low dose prednisolone alone helps to achieve repeat remission in shorter time in relapsed pemphigus vulgaris patients who had been treated with standard rheumatoid arthritis protocol of rituximab for induction of preceding remission	We expect a difference of 4 weeks in obtaining remission between the two groups

Secondary Outcome

Outcome	TimePoints
Proportion of patients in each group who achieve complete remission on minimal therapy	6 months
Proportion of patients in each group who achieve complete remission off therapy	7 months
Comparison of total cumulative dose of prednisolone required in both arms	5 months
Comparison of adverse effects between the groups	9 months
Comparison of frequency of repeat relapse within the 9-month study period	9 months

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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)
Modification(s)

06/06/2023

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

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This is a Randomised controlled trial to find out which of the treatment option between the combination of low dose rituximab( single dose of 500mg) and low dose prednisolone (0.3mg/kg) versus low dose prednisolone (0.3mg/kg) alone helps to achieve repeat remission in shorter time in relapsed pemphigus vulgaris patients who had been treated with standard rheumatoid arthritis protocol of rituximab for induction of preceding remission.

Secondary objectives:

1) Comparison of time to achieve remission on minimal treatment

2) Comparison of time to achieve remission off treatment

3) Comparison of total cumulative dose of prednisolone required in both arms in a 9-month study period

4) Comparison of adverse effects between the groups

5) Comparison of frequency of repeat relapse within the 9-month study period

There is a lack of research that reports a suitable treatment of relapse in patients of PV who had achieved remission after treatment with standard rheumatoid arthritis protocol. To the best of our knowledge, this study is first of its kind to assess a better treatment option for relapse between low dose rituximab and low dose prednisolone. This will help in bridging the knowledge gap and will help in better treatment of PV relapse.