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TL011 in Severe, Active Rheumatoid Arthritis Patients

NCT ID: NCT01123070

Last Updated: 2021-10-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-05

Study Completion Date

2012-04-23

Brief Summary

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

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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TL011

TL011 infusions

Group Type EXPERIMENTAL

TL011, anti CD20, for the treatment of rheumatoid arthritis

Intervention Type BIOLOGICAL

TL011 administered by 2 infusions, 2 weeks apart

MabThera

MabThera infusions

Group Type ACTIVE_COMPARATOR

MabThera infusions

Intervention Type BIOLOGICAL

MabThera, administered by 2 infusions, 2 weeks apart

Interventions

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TL011, anti CD20, for the treatment of rheumatoid arthritis

TL011 administered by 2 infusions, 2 weeks apart

Intervention Type BIOLOGICAL

MabThera infusions

MabThera, administered by 2 infusions, 2 weeks apart

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adult subjects
* Rheumatoid arthritis as defined by the 1987 ACR Classification
* Severe active seropositive disease
* Inadequate response or intolerance to other DMARDs
* Treatment with MTX

Exclusion Criteria

* Rheumatic autoimmune disease other than RA
* Active infection
* Known immunodeficiency syndrome
* Positive Hepatitis B surface antigen or antibodies to Hepatitis C
* History of cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Pharmaceutical Industries, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Teva Investigational Site 5428

Pilsen, , Czechia

Site Status

Teva Investigational Site 5426

Prague, , Czechia

Site Status

Teva Investigational Site 5429

Uherské Hradiště, , Czechia

Site Status

Teva Investigational Site 5123

Budapest, , Hungary

Site Status

Teva Investigational Site 5122

Budapest, , Hungary

Site Status

Teva Investigational Site 5125

Debrecen, , Hungary

Site Status

Teva Investigational Site 5124

Szeged, , Hungary

Site Status

Teva Investigational Site 3077

Florence, , Italy

Site Status

Teva Investigational Site 3075

Genova, , Italy

Site Status

Teva Investigational Site 3078

Pavia, , Italy

Site Status

Teva Investigational Site 3076

Siena, , Italy

Site Status

Teva Investigational Site 3170

Barakaldo, , Spain

Site Status

Teva Investigational Site 3168

Guadalajara, , Spain

Site Status

Teva Investigational Site 3167

Madrid, , Spain

Site Status

Teva Investigational Site 3169

Seville, , Spain

Site Status

Teva Investigational Site 3434

Manchester, , United Kingdom

Site Status

Teva Investigational Site 3433

Staffordshire, , United Kingdom

Site Status

Teva Investigational Site 3435

Wirral, Merseyside, , United Kingdom

Site Status

Countries

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Czechia Hungary Italy Spain United Kingdom

Other Identifiers

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2009-015702-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RA-TL011-101

Identifier Type: -

Identifier Source: org_study_id

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