Imatinib treatment of autoimmune bullous diseases

JRCT ID: jRCTs051180069

Registered date:19/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Autoimmune bullous disease including pemphigus group and pemphigoid group
• Date of first enrollment: 12/04/2018
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Imatinib 800 mg a day p.o. for seven days will be started within 14 days of starting steroid therapy (and when the bed is secured). Imatinib 800 mg a day p.o. for seven days will be started afterregistered in the trial (and when the bed is secured) in patients with mild symptoms and will not take systemic steroid therapy.

Outcome(s)

• Primary Outcome: PDAI/BPDAI

Secondary Outcome

Titers of autoantibodies in serum.
Titers of antibodies in other body fluids including saliva and blister contents.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 100age old
• Gender: Both

Include criteria

Eligibility (inclusion) criteria
1) Diagnosed as pemphigus group or pemphigoid group.
2) Those who are not expected to be treated with pulse steroid therapy or intravenous immunoglobulin (IVIG).
3) The age at the time of consent acquisition is 20 or over 20 years old.
4) The latest blood test and liver function test within 4 weeks before registration satisfy all of the following:
Neutrophil count >= 1,500/mm3; platelet count >= 75,000/mm3; AST (GOT) < 120 IU/L; ALT(GPT) < 120 IU/L; total bilirubin < 1.8 mg/dL.
5) Males, those agreeing to contraception for 4 weeks from the start of the test drug administration to the final administration day of the test drug. Females, those after surgical contraceptive surgery such as postmenopausal (more than one year since the last menstruation), or bilateral oophorectomy.
6) Written informed consent by the patient has been obtained.

Exclude criteria

Exclusion criteria
1) No history of allergy to Imatinib.
2) Those who have one of the following complications:
Serious heart disease, serious liver disorder, serious renal disorder or past history of such conditions.
3) Those who had given consent of participation in other trials within 4 weeks before the acquisition of this study.
4) Those who are judged to be unsuitable for carrying out this study by the investigator or shared medical doctors.

Related Information

• Primary Sponsor: Kabashima Kenji
• Secondary Sponsor: Endo Yuichiro
• Source(s) of Monetary Support: Mitsubishi Tanabe Pharma Corporation,AMED (Japan Agency for Medical Research and Development)
• Secondary ID(s): Nil known