Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01338103
• Date of registration: 17/04/2011
• Prospective Registration: No
• Primary sponsor: Rabin Medical Center
• Public title: Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex
• Scientific title: Treatment of Moderate to Severe Patients With Pemphigus With the Monoclonal Anti CD20 Antibody Rituximab at a Protocol of 1000mgX2 and Assessment of Their Immune Status Via the Cylex Test
• Date of first enrolment: January 2010
• Target sample size: 10
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01338103
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Daniel Mimouni, MD

• Name: Daniel Mimouni, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Pemphigus patients with moderate-severe disease

Exclusion Criteria:

1. Pregnancy or lactation

2. Woman of reproductive age not using birth control measures.

3. Prior severe allergy or anaphylaxis with a human monoclonal antibody

4. Heart failure

5. Unstable angina or ischemic heart disease

6. Uncontrolled arrhythmia

7. HIV positive

8. Active hepatitis B infection or positive for hepatitis C virus (HCV) antibodies.

9. Severe dementia or a psychiatric illness

10. Active acute infection



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pemphigus

Intervention(s)

Drug: Rituximab

Primary Outcome(s)

Complete or partial remission off treatment (based on the consensus statement for pemphigus) [Time Frame: 6 months after treatment]

Secondary ID(s)

5474

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Leumit Health Services