|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ChiCTR |
|
Last refreshed on:
|
18 April 2017 |
|
Main ID: |
ChiCTR-TRC-12003540 |
|
Date of registration:
|
2012-12-19 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Use of intravenous Methotrexate plus Glucocorticoid for the Treatment of Pemphigus:A multicenter,randomized and controlled clinical trial
|
|
Scientific title:
|
Guideline-oriented Research in the Management of Some Common and Severe Skin Diseases |
|
Date of first enrolment:
|
2011-08-01 |
|
Target sample size:
|
Glucocorticoid group:90;Glucocorticoid plus MTX group:90; |
|
Recruitment status: |
Completed |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=6020 |
|
Study type:
|
Interventional study |
|
Study design:
|
Randomized parallel controlled trial
|
|
Phase:
|
Post-market
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Baoxi Wang
|
|
Address:
|
12 Jiangwangmiao Street, Nanjing, China
210042
|
|
Telephone:
|
+86 025-85478071 |
|
Email:
|
wangbx@ncstdlc.org |
|
Affiliation:
|
Institute of dermatology, Chinese Academyof Medical Sciences |
|
|
Name:
|
Yi Liu
|
|
Address:
|
12 Jiangwangmiao Street, Nanjing, China
210042
|
|
Telephone:
|
+86 025-85478992 |
|
Email:
|
hangyezhuanxiang@163.com |
|
Affiliation:
|
Institute of dermatology, Chinese Academyof Medical Sciences |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: (1) 18 to 75 years old, male or female;
(2) Meet the diagnostic criteria for pemphigus(erythema and vesicles on skins and/or mucous membranes; dermatopathology shows bulla above the basal cell layer; direct or indirect immunofluorescence (DIF/IIF) staining reveals IgG and/or C3 deposited as reticular-pattern in the intercellular substance of the epidermis);
(3) Skin lesion scores of Pemphigus Disease Area Index(PDAI) are between 30 to 90 points(scoring criteria refers to Appendix 11);
(4) Patients completely understand the trial and voluntarily sign the informed consent.
Exclusion criteria: (1) Regimen or dose of treatment for pemphigus have changed within one month;
(2) Esophagus involved;
(3) Subjects who have severe local or systemic acute or chronic infection which is difficult to control and may affect the efficacy of the drugs or the clinical evaluation;
(4) Subjects who have severe heart, lung, liver (ALT=1.5×ULN), kidney or other severe diseases;
(5) Pregnant and lactating female or subjects who have fertility plan recently;
(6) With a history of malignant tumor;
(7) Subjects who are allergic to the test drugs or have contraindications;
(8) With other skin diseases that may affect the clinical evaluation;
(9) Other conditions which researchers consider the subjects not compatible to the trial.
Age minimum:
18
Age maximum:
75
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Pemphigus
|
|
Intervention(s)
|
|
Glucocorticoid group:This group receives systemic glucocorticoid, initially, with prednisone at 1mg/kg/day.;Glucocorticoid plus MTX group:This group receives systemic glucocorticoid plus MTX and starts with prednisone at 1mg/kg/day and MTX IV drip infusion at 15mg/week. Then we adjust the dose of glucocorticoid according to the patients' responses. ;
|
|
Primary Outcome(s)
|
|
PDAI;Date of stopping blisterring;Date of erosion surface completely drying;Date of glucocorticoid starting to reduce;Glucocorticoid dosage;
|
|
Secondary Outcome(s)
|
|
Electrocardiogram;CTChest X-ray/C;
|
|
Source(s) of Monetary Support
|
|
Ministry of Finance of China
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|