NCT01338103

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 2, 2011

Status Verified

March 1, 2011

Enrollment Period

2.4 years

First QC Date

April 17, 2011

Last Update Submit

April 29, 2011

Conditions

Pemphigus

Keywords

PemphigusRituximabCylex

Outcome Measures

Primary Outcomes (1)

  • Complete or partial remission off treatment (based on the consensus statement for pemphigus)

    6 months after treatment

Study Arms (1)

Rituximab

EXPERIMENTAL
Drug: Rituximab

Interventions

RituximabDRUG

intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks.

Rituximab

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Pemphigus patients with moderate-severe disease

You may not qualify if:

  • Pregnancy or lactation
  • Woman of reproductive age not using birth control measures.
  • Prior severe allergy or anaphylaxis with a human monoclonal antibody
  • Heart failure
  • Unstable angina or ischemic heart disease
  • Uncontrolled arrhythmia
  • HIV positive
  • Active hepatitis B infection or positive for hepatitis C virus (HCV) antibodies.
  • Severe dementia or a psychiatric illness
  • Active acute infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bullous diseases clinic, Department of dermatology, Rabin Medical Center

Petah Tikva, 49100, Israel

RECRUITING

MeSH Terms

Conditions

Pemphigus

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Daniel Mimouni, MD

CONTACT

972-3-9376658

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2011

First Posted

April 19, 2011

Study Start

January 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 2, 2011

Record last verified: 2011-03

Locations

IL(1)