Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus

Conditions

• Pemphigus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine — DRUG
  Protein A Immunoadsorption: performed on 3 consecutive days every 3 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 every 3 weeks Azathioprine: 2.5 mg/kg body weight daily p.o.

Study Details

Pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies against certain proteins important for maintaining skin integrity. Protein A immunoadsorption is a dialysis-like technique selectively removing the antibodies from patient's blood. Rituximab is a synthetic antibody capable of destroying B cells. B cells are responsible for production of antibodies in the patients blood that, in turn, lead to clinical signs of pemphigus. Dexamethasone pulse therapy is a high-dose short-term corticosteroid therapy that may be used to suppress autoantibody production in pemphigus. While each of these three therapies had been used to treat pemphigus, none was shown effective in all cases. The hypothesis of this study is that a combination of protein A immunoadsorption, rituximab and dexamethasone is more effective that either of these treatments alone in achieving a rapid and durable improvement or cure in patients with pemphigus.

Key Dates

Start date

Jan 31, 2008

Status verified

Jan 2017

Primary completion

Jul 31, 2011

Completion

Jul 31, 2011

Study Design

Enrollment

23 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: Immunoadsorption/Dexamethasone/Rituximab

Primary Outcome Measure

Number of Patients Achieving a Short- and Long-term Remission of Pemphigus [ Time Frame: up to 43 months ]