TL011 in Severe, Active Rheumatoid Arthritis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01123070
First received: May 11, 2010
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Compare pharmacokinetics (PK) of rituximab following IV infusions of TL011 and MabThera® in subjects with RA. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of TL011 and MabThera® in subjects with RA [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Additional pharmacokinetic (PK) parameters, pharmacodynamic (PD) and preliminary efficacy of TL011 and MabThera® in subjects with RA [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: February 2010
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123070

Locations
Czech Republic
Teva Investigational Site 5428
Plzen, Czech Republic
Teva Investigational Site 5426
Prague 2, Czech Republic
Teva Investigational Site 5429
Uherske Hradiste, Czech Republic
Hungary
Teva Investigational Site 5123
Budapest, Hungary
Teva Investigational Site 5122
Budapest, Hungary
Teva Investigational Site 5125
Debrecen, Hungary
Teva Investigational Site 5124
Szeged, Hungary
Italy
Teva Investigational Site 3077
Firenze, Italy
Teva Investigational Site 3075
Genova, Italy
Teva Investigational Site 3076
Siena, Italy
Spain
Teva Investigational Site 3170
Barakaldo, Spain
Teva Investigational Site 3168
Guadalajara, Spain
Teva Investigational Site 3167
Madrid, Spain
Teva Investigational Site 3169
Sevilla, Spain
United Kingdom
Teva Investigational Site 3434
Manchester, United Kingdom
Teva Investigational Site 3433
Staffordshire, United Kingdom
Teva Investigational Site 3435
Wirral, Merseyside, United Kingdom
Sponsors and Collaborators
Teva Pharmaceutical Industries
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01123070     History of Changes
Other Study ID Numbers: RA-TL011-101, 2009-015702-18
Study First Received: May 11, 2010
Last Updated: May 14, 2012
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014