Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

• ClinicalTrials.gov Identifier: NCT00656656
• Recruitment Status: Completed
• First Posted: April 11, 2008
• Results First Posted: December 22, 2016
• Last Update Posted: March 13, 2017
• Sponsor: University of Luebeck
• Information provided by (Responsible Party): Michael Kasperkiewicz, University of Luebeck

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pemphigus
• Intervention: Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine
• Enrollment: 23

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Immunoadsorption/Dexamethasone/Rituximab
Arm/Group Description	Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks Rituximab: 1000 mg i.v. given twice at a 2-week interval Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks Azathioprine: 2.5 mg/kg body weight daily p.o. Mycophenolate mofetil 2 g/d p.o.
Period Title: Overall Study
Started	23
Completed	23
Not Completed	0

Baseline Characteristics

Arm/Group Title		Immunoadsorption/Dexamethasone/Rituximab
Arm/Group Description		Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks Rituximab: 1000 mg i.v. given twice at a 2-week interval Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks Azathioprine: 2.5 mg/kg body weight daily p.o. Mycophenolate mofetil 2 g/d p.o.
Overall Number of Baseline Participants		23
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	23 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	17 73.9%
	>=65 years	6 26.1%
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	23 participants
		55; (26 to 75)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	23 participants
	Female	11 47.8%
	Male	12 52.2%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Germany	Number Analyzed	23 participants
		23

Outcome Measures

1. Primary Outcome

Title	Number of Patients Achieving a Short- and Long-term Remission of Pemphigus
Description	Clinical remission was graded as partial remission on therapy, complete remission on therapy and complete remission off therapy, as described by Murell et al, J Am Acad Dermatol, 2008; 58:1043-6.
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Immunoadsorption/Dexamethasone/Rituximab
Arm/Group Description:	Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks Rituximab: 1000 mg i.v. given twice at a 2-week interval Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks Azathioprine: 2.5 mg/kg body weight daily p.o. Mycophenolate mofetil 2 g/d p.o.
Overall Number of Participants Analyzed	23
Measure Type: Count of Participants; Unit of Measure: Participants
	23 100.0%

2. Secondary Outcome

Title	Number of Patients Who Experienced Side-effects of Treatment
Description	Patients who experienced side-effects were counted. In addition, the nature and severity of side-effects were recorded.
Time Frame	up to 43 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Immunoadsorption/Dexamethasone/Rituximab
Arm/Group Description:	Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks Rituximab: 1000 mg i.v. given twice at a 2-week interval Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks Azathioprine: 2.5 mg/kg body weight daily p.o. Mycophenolate mofetil 2 g/d p.o.
Overall Number of Participants Analyzed	23
Measure Type: Count of Participants; Unit of Measure: Participants
	2 8.7%

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Immunoadsorption/Dexamethasone/Rituximab
Arm/Group Description	Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks Rituximab: 1000 mg i.v. given twice at a 2-week interval Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks Azathioprine: 2.5 mg/kg body weight daily p.o. Mycophenolate mofetil 2 g/d p.o.
All-Cause Mortality
	Immunoadsorption/Dexamethasone/Rituximab
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Immunoadsorption/Dexamethasone/Rituximab
	Affected / at Risk (%)
Total	2/23 (8.70%)
Infections and infestations
Sepsis	1/23 (4.35%)
extensive herpes simplex	1/23 (4.35%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Immunoadsorption/Dexamethasone/Rituximab
	Affected / at Risk (%)
Total	0/23 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Prof. Dr. Detlef Zillikens
• Organization: University of Lübeck
• Phone: +49-451-500-41500
• EMail: detlef.zillikens@uksh.de

• Responsible Party: Michael Kasperkiewicz, University of Luebeck
• ClinicalTrials.gov Identifier: NCT00656656
• Other Study ID Numbers: Pemphigus-Luebeck
• First Submitted: April 7, 2008
• First Posted: April 11, 2008
• Results First Submitted: October 28, 2016
• Results First Posted: December 22, 2016
• Last Update Posted: March 13, 2017