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

• Sponsor: Rabin Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01338103
• Collaborator: Leumit Health Services (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 29
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether Rituximab, in the same doses as used in rheumatoid arthritis patients, will benefit pemphigus patients. It also tests immune function via the Cylex assay in pemphigus patients before and after treatment with RItuximab.

Condition or Disease	Intervention/Treatment	Phase
Pemphigus	Drug: Rituximab	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: Jan 1, 2010
• Anticipated Primary Completion Date: Jun 1, 2012
• Anticipated Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rituximab	Drug: Rituximab; intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bullous diseases clinic, Department of dermatology, Rabin Medical Center	Petah Tiqva		Israel	49100

Sponsors and Collaborators

• Rabin Medical Center
• Leumit Health Services

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01338103
• Other Study ID Numbers: 5474
• First Posted: Apr 19, 2011
• Last Update Posted: May 2, 2011
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: Pemphigus; Rituximab; Cylex
• Additional relevant MeSH terms: Pemphigus; Rituximab

Study Results

No Results Posted as of May 2, 2011