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Rituximab in IgG4-RD: A Phase 1-2 Trial

NCT01584388 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-07-02

Study results available
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Summary

The primary objective of this study is to evaluate the safety and effectiveness of rituximab in IgG4-RD.

Conditions

  • Retroperitoneal Fibrosis
  • Autoimmune Pancreatitis
  • Sialadenitis
  • Pseudotumor

Interventions

DRUG

Rituximab

Rituximab 1000 mg IV times two doses, separated by approximately 15 days.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • John H Stone, MD, MPH · Massachusetts General Hospital (Rheumatology Unit)

  • Arezou Khosroshahi, MD · Massachusetts General Hospital (Rheumatology Unit)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-01-31
Completion
2015-01-31
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01584388 on ClinicalTrials.gov