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Addition of Rituximab to Leflunomide in Patients With Active Rheumatoid Arthritis

NCT01244958 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2016-03-24

No results posted yet for this study

Summary

Combination of rituximab (RTX) with several different chemotherapeutic regimes has proven synergistic effects in patients with either lymphoma or autoimmune diseases. First data of uncontrolled trials with the combination of RTX and leflunomide (LEF) are available.

Conditions

Interventions

BIOLOGICAL

Rituximab

1000 mg Rituximab infusion

DRUG

Placebo

infusion of Sodium citrate, Polysorbate, Sodium chloride

Sponsors & Collaborators

  • Frank Behrens

    lead OTHER

Principal Investigators

  • Frank Behrens, Dr. med. · Department of Medicine II / Rheumatology Johann Wolfgang Goethe-Universität

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01244958 on ClinicalTrials.gov