Use of Oral Methotrexate plus Glucocorticoid for the Treatment of bullous pemphigoid:A multicenter,randomized and controlled clinincal trial

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TRC-12003593
• Date of registration: 2012-12-30
• Prospective Registration: No
• Primary sponsor: Institute of dermatology; Chinese Academy of Medical Sciences
• Public title: Use of Oral Methotrexate plus Glucocorticoid for the Treatment of bullous pemphigoid:A multicenter,randomized and controlled clinincal 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: Glucocorticoids group:90;Glucocorticoid plus MTX group:90;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=5967
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Yi Liu
• Affiliation: Institute of dermatology; Chinese Academy of Medical Sciences

• Name: BAoxi Wang
• Affiliation: Institute of dermatology; Chinese Academy of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: 1. Above 18 years old,male or female;
2. According with the diagnostic criteria for bullous pemphigoid(erythema and vesicles on skins and/or mucous membranes;dermatopathology shows subepidermal bulla; direct or indirect immunofluorescence (DIF/IIF) staining reveals IgG and/or C3 deposited as linear-pattern along the basement membrane zone; BP180 ELISA positive);
3. Clinical severity rating>1, the number of local vesicles<=10(scoring criteria refers to Appendix 13);
4. Subjects completely understand the trial and voluntarily sign the informed consent.
Exclusion criteria: 1. Regimen or dose of treatment for bullous pemphigoid have changed within one month;
2. 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;
3. Subjects who have severe heart, lung, liver (ALT/AST=1.5×ULN), kidney or other severe diseases;
4. Pregnant and lactating female or subjects who have fertility plan recently;
5. With a history of malignant tumor;
6. Subjects who are allergic to the test drugs or have contraindications;
7. With other skin diseases that may affect the clinical evaluation;
8. Other conditions which researchers consider the subjects not compatible to the trial.

Age minimum: 18
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

bullous pemphigoid

Intervention(s)

Glucocorticoids group:This group receives systemic glucocorticoid, initially, with prednisone at 1mg/kg/day. Then we adjust the dose of glucocorticoid according to the patients' responses.;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)

Pemphigoid antibodies titer;Glucocorticoid dosage;Date of glucocorticoid starting to reduce;Date of erosion surface completely drying;

Secondary Outcome(s)

Blood-routine;Urine-routine;Stool routine test;Urine pregnancy test;Electrocardiogram;Chest X-ray/CT;Pemphigoid antibodies titer;

Source(s) of Monetary Support

Ministry of Finance of the People's Republic of China