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Evaluation of the efficasy of intralesional rituximab injection for remision of recalcitrant lesions in the patients with pemphigus vulgaris.

Protocol summary

Study aim
Evaluation of efficacy of intralesional rituximab injection in the treatment of recalcitrant mucocutaneous lesions in patients with pemphigus vulgaris
Design
Since pemphigus is not a common disease and there is no large-scale controlled clinical trial on treatment regimens, only one study found that rituximab was studied in only 3 patients. Therefore, the primary study should be based on the pilot and on 15 patients will be treated.
Settings and conduct
Patients on the first day and on Day 15 will receive rituximab at a dose of 5 mg / cm2 of the drug (i.e., per centimeter of the lesion of 0.5 cc) intra-lesion. Before injection of rituximab, intravenous injections of hydrocortisone 100 mg and chlorpheniramine and one dose of acetaminophen 500 mg tablet will be given. Patients will be followed for 6 months.
Participants/Inclusion and exclusion criteria
A total of 15 patients with pemphigus vulgaris referring to the Dermatology Clinic of the Razi Hospital, which have inclusion criterias, will be studied. ▪ Inclusion Criteria: 1. Clinically , histologically and immunologically approved pemphigus vulgaris. 2. Mucosal or skin involvement with totally maximum diameter of 6 cm or 20 cm2 that are resistant to common immunosuppressive treatment. 3. Inadequate response after three intralesional injection of triamcinolone acetonide or use of potent topical steroids for 2 months 4. Lack of active lesion 5. Steroid dose of 20 mg or less. ▪ Exclusion criteria: 1. Contraindication for the treatment of rituximab . 2. Receiving intravenous rituximab within 6 months before the start of the study.
Intervention groups
Patients with pemphigus vulgaris who have recalciterant mucocutaneous lesions.
Main outcome variables
Anti desmogeline1 - Anti desmogeline 3 - CD4 cell count - CD19 cell count and size of lesions.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020250N3
Registration date: 2018-06-19, 1397/03/29
Registration timing: prospective

Last update: 2018-06-19, 1397/03/29
Update count: 0
Registration date
2018-06-19, 1397/03/29
Registrant information
Name
Narges Ghandi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5561 8989
Email address
nghandi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficasy of intralesional rituximab injection for remision of recalcitrant lesions in the patients with pemphigus vulgaris.
Public title
Effect of intralesional injection of rituximab in recalcitrant pemphigus lesions.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
suffering from pemphigus vulrais, confirmed by clinical, histoligical and immunological criteria. Skin or mucosal lesions with maximum diameter of 6 cm or 20 cm2 which are recalcitrant (means continued development of new lesions, continued extension of old lesions, or failure of established lesions to begin to heal despite 3 weeks of therapy on 1.5 mg/kg/d of prednisone equivalent with or without any of the following agents: cyclophosphamide 2 mg/kg/d for 12 weeks; azathioprine 2.5 mg/kg/d for12 weeks (if thiopurine s-methyltransferase level is normal); methotrexate 20 mg/wk for 12 weeks; or mycophenolate mofetil 3 g/d for 12 weeks.). Insufficient response to three times intralesional injection of triamcinolone acetonide or topical super potent corticosteroid for at least 1 month. no new lesion in recent 12 weeks. no cardiac or infectious contraindication to rituximab. oral steroid usage of <= 20 mg/d.
Exclusion criteria:
Patients with active lesions (expansion of previous old lesions or new lesions in recent 12 weeks). Contraindications to rituximab (including hepatitis B, hepatitis C, progressive neurologic disease, angina, arrhythmia, herpes virus infection, CMV infection, acute pneumonia, renal diseases, lactation, hyperphosphatemia, hypocalcemia, hyperkalemia, anemia, low platelet or leukocyte count. Injection of intravenous rituximab in recent 6 months.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
quazi-experimantal

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics committee
Street address
Tehran University of Medical Sciences, Office of Vice Chancellor for Research and Technology, 6th floor, Ghods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-03-07, 1396/12/16
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4747

Health conditions studied

1

Description of health condition studied
pemphigus vulgaris
ICD-10 code
L10.0
ICD-10 code description
Pemphigus vulgaris

Primary outcomes

1

Description
Anti desmogline 1
Timepoint
baseline , 3 months , 6 months later
Method of measurement
blood sampling

2

Description
Anti desmogline 3
Timepoint
baseline , 3 months , 6 months
Method of measurement
blood sampling

3

Description
CD4 cell count
Timepoint
baseline , 15 day and 1 month later
Method of measurement
blood sampling

4

Description
CD19 cell count
Timepoint
baseline , 15 day and 1 month later
Method of measurement
blood sampling

Secondary outcomes

1

Description
disease severity
Timepoint
before intervention and 1, 3, 6 months after intervention
Method of measurement
Pemphigus Disease Area Index (PDAI )

2

Description
patient satisfaction
Timepoint
baseline, 1 month , 3 month , 6 month later
Method of measurement
Visual analyze scale

3

Description
quality of life
Timepoint
baseline, 1 month , 3 month , 6 month later
Method of measurement
pemphigus quality of life questioner

4

Description
size of lesion
Timepoint
baseline, 15 days , 1 month , 3 month , 6 month later
Method of measurement
ruler

Intervention groups

1

Description
Intervention group: for 15 patient with mucocutaneous recalcitrant lesion of pemphigus vulgaris , we will prescribe intralesional injection of rituximab with dose of 5 mg/cm2 ( 0/5 cc per 1 cm2 of lesion ) , we will take patients stat dose of hydrocortisone 100 mg , chlorpheniramin and acetaminophen 500 mg before of injection and we will follow them for 6 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Narges Ghandi
Street address
District 12 , vahdat eslami square
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0174
Email
nghandi@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Doctor Seyyed Ahmad Rezayi
Street address
sixth floor, Vice chancellor of research and technology, central organization of Tehran University of Medical Sciences, at the corner of Qods street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Fax
+98 21 8163 3623
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
EBRAHIM MAZLOOM
Position
RESIDENT
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 1, bakhshandegan Avenue, Valiasr BLV,Tehran
City
Tehran
Province
Tehran
Postal code
1516744163
Phone
+98 21 8820 8156
Email
hanymazloom@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Narges Ghandi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
District 12, vahdate eslami square, Razi hospital
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
nghandi@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ebrahim Mazloom
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 1, bakhshandegan avenue, valiasr BLV,Tehran
City
Tehran
Province
Tehran
Postal code
1516744163
Phone
+98 21 8820 8156
Email
hanymazloom@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data including age, sex, duration of illness, drugs used by the patient, amount and duration of taking corticosteroid and immunosuppressive, history of rituximab injection, duration of previous injection of rituximab, complications of intra-lesion injection of rituximab, severity of complications, severity of disease and satisfaction and score of Quality of life, The changes in desmagolin levels 1 and 3, and changes in levels of CD4 and CD19 cell count will be released.
When the data will become available and for how long
As soon as completion of the study and analysis of the data, the results will be available to the researchers.
To whom data/document is available
All investigators , students , doctors and, in general, people working in the field of autoimmune bullous disorders.
Under which criteria data/document could be used
To achieve a safe and low-cost effective treatment protocol for patients with pemphigus vulgaris who suffer from recalcitrant mucosal lesions.
From where data/document is obtainable
Dept. of Research and Technology of Tehran University of Medical Sciences and Autoimmune bullous Disorders Research Center and Iranian Record of Clinical Trial website
What processes are involved for a request to access data/document
Login to Autoimmune Bullous Disorders Research Center and Iranian Record of clinical trial Center
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