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TL011 in Severe, Active Rheumatoid Arthritis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01123070
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis Biological: MabThera infusions Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: TL011
TL011 infusions
Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis
TL011 administered by 2 infusions, 2 weeks apart

Active Comparator: MabThera
MabThera infusions
Biological: MabThera infusions
MabThera, administered by 2 infusions, 2 weeks apart




Primary Outcome Measures :
  1. Compare pharmacokinetics (PK) of rituximab following IV infusions of TL011 and MabThera® in subjects with RA. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Safety and tolerability of TL011 and MabThera® in subjects with RA [ Time Frame: 1.5 years ]
  2. Additional pharmacokinetic (PK) parameters, pharmacodynamic (PD) and preliminary efficacy of TL011 and MabThera® in subjects with RA [ Time Frame: 1.5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123070


Locations
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Sponsors and Collaborators
Teva Pharmaceutical Industries
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Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01123070    
Other Study ID Numbers: RA-TL011-101
2009-015702-18 ( EudraCT Number )
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents