Trial Outcomes & Findings for Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus (NCT NCT00656656)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

up to 43 months

Results posted on

2017-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Immunoadsorption/Dexamethasone/Rituximab 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 Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immunoadsorption/Dexamethasone/Rituximab n=23 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment Germany	23 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 43 months

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.

Outcome measures

Outcome measures
Measure	Immunoadsorption/Dexamethasone/Rituximab n=23 Participants 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.
Number of Patients Achieving a Short- and Long-term Remission of Pemphigus	23 Participants

SECONDARY outcome

Timeframe: up to 43 months

Patients who experienced side-effects were counted. In addition, the nature and severity of side-effects were recorded.

Outcome measures

Outcome measures
Measure	Immunoadsorption/Dexamethasone/Rituximab n=23 Participants 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.
Number of Patients Who Experienced Side-effects of Treatment	2 Participants

Adverse Events

Immunoadsorption/Dexamethasone/Rituximab

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Immunoadsorption/Dexamethasone/Rituximab n=23 participants at risk 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.
Infections and infestations Sepsis	4.3% 1/23
Infections and infestations extensive herpes simplex	4.3% 1/23

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. Detlef Zillikens

University of Lübeck

Phone: +49-451-500-41500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place