immunoglobulin infusion as adjuvant therapy in patients with Pemphigus Vulgaris
- Conditions
- patients with Pemphigus vulgarisMedDRA version: 16.0 Level: LLT Classification code 10052802 Term: Pemphigus vulgaris System Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2013-000211-24-DE
- Lead Sponsor
- Ruprecht-Karls-University Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
1.Patients with clinical signs of Pemphigus vulgaris
2.Patients with Pemphigus vulgaris proven by direct immunofluorescence (deposition of IgG intraepidermally on the keratinocyte membrane)
3.Patients with relapse of Pemphigus vulgaris < 2 months before inclusion. (Relapse is defined by the appearance of 3 or more new lesions a month that do not heal spontaneously within 1 week, or by the extension of established lesions in a person who has achieved disease control).
4.Prednisone doses (or the equivalent) = 10 mg per day
5.Indication for or therapy with additional immunosuppressive therapy (e.g. Azathioprine or Mycophenolatemofetil)
6.Age = 18years
7.Written informed consent, signed and dated
8.Sufficient knowledge of languages (German)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1.Patients with drug-induced forms of Pemphigus Vulgaris are excluded
2.Patients relapsing at a dose under 10 mg Prednisone (or the equivalent) per day
3.Clinically significant heart disease (NYHA Class III or IV)
4.Clinically significant renal insufficiency (CDC III or IV)
5.Patients with a history of thromboembolic episodes such as deep vein thromboses, myocardial infarction or stroke
6.HIV, HCV or HBV infections
7.Bleeding disorders
8.Patients with serious intercurrent illness, requiring hospitalization
9.Patients taking or requiring immunosuppressive drugs such as systemic corticosteroids other than study medication for a distinct medical disorder (e.g. rheumatoid arthritis). Topical or inhalational steroids are permitted
10.Patients treated with steroid pulse therapy, plasma exchange therapy within 30 days, other biotherapeutics (e.g. TNF-a inhibitors, interferons, rituximab) or HD-IVIg within 60 days before the start of study treatment.
11.Active malignancy within 1 year prior to entry into the study, except for cured non-melanoma skin cancer and cervical carcinoma in situ.
12.Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
13.Participation in chemotherapy or irradiation therapy within 4 weeks prior to enrolment.
14.Participation in any other clinical trial within 4 weeks prior to enrolment and treatment with another investigational agent within 5 elimination half-lives prior to enrolment.
15.Pregnancy or breastfeeding woman, or women of childbearing potential refusing or unable to use effective means of contraception (i.e. oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, female sterilisation or condoms).
16.History of severe allergic reactions to study drugs, vaccines or unknown allergens
17.Patients with known absolute IgA deficiency
18.Patients who are unable to be treated due to obesity
19.Patients who are unable to receive concomitant immunosuppressive therapy
20.Suspicion of drug and / or alcohol abuse
The patient planned to be enrolled is an employee of any involved investigator or any involved institution including the sponsor of the trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method