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

May 11, 2010
May 14, 2012
February 2010
April 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01123070 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
TL011 in Severe, Active Rheumatoid Arthritis Patients
Not Provided

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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
  • Experimental: TL011
    TL011 infusions
    Intervention: Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis
  • Active Comparator: MabThera
    MabThera infusions
    Intervention: Biological: MabThera infusions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
May 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Hungary,   Italy,   Spain,   United Kingdom
 
NCT01123070
RA-TL011-101, 2009-015702-18
Not Provided
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Not Provided
Teva Pharmaceutical Industries
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP