MedTrace Logo

TL011 in Severe, Active Rheumatoid Arthritis Patients

NCT01123070 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-10-04

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine the safety and pharmacology of TL011 in patients with severe rheumatoid arthritis.

Conditions

Interventions

BIOLOGICAL

TL011, anti CD20, for the treatment of rheumatoid arthritis

TL011 administered by 2 infusions, 2 weeks apart

BIOLOGICAL

MabThera infusions

MabThera, administered by 2 infusions, 2 weeks apart

Sponsors & Collaborators

  • Teva Pharmaceutical Industries, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-05
Primary Completion
2012-04-23
Completion
2012-04-23

Countries

  • Czechia
  • Hungary
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01123070 on ClinicalTrials.gov