TL011 in Severe, Active Rheumatoid Arthritis Patients

Teva Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Biological: MabThera infusions; Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis

Study type: Interventional

Funder types: Industry

Identifiers

NCT01123070

2009-015702-18 (EudraCT Number)

RA-TL011-101

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups

TL011

Experimental group

Description:

TL011 infusions

Treatment:

Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis

MabThera

Active Comparator group

Description:

MabThera infusions

Treatment:

Biological: MabThera infusions