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A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy

NCT00936546 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-07-13

No results posted yet for this study

Summary

This study will evaluate the safety and efficacy of the combination of rituximab and methotrexate to treat disabling fibrosing skin disorders.Rituximab will be administered at baseline and month 6. The drug will be considered efficacious if the skin thickness diminishes substantially.

Conditions

  • Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis)

Interventions

DRUG

Rituximab

Mabthera, Rituximab 1000 mg I.V.

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Filip De Keyser, MD, PhD · University Hospital, Ghent

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2015-06-03
Completion
2015-06-03

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT00936546 on ClinicalTrials.gov