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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

Tracking Information
First Submitted Date  ICMJE May 11, 2010
First Posted Date  ICMJE May 14, 2010
Last Update Posted Date May 15, 2012
Study Start Date  ICMJE February 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2010)
Compare pharmacokinetics (PK) of rituximab following IV infusions of TL011 and MabThera® in subjects with RA. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2010)
  • Safety and tolerability of TL011 and MabThera® in subjects with RA [ Time Frame: 1.5 years ]
  • Additional pharmacokinetic (PK) parameters, pharmacodynamic (PD) and preliminary efficacy of TL011 and MabThera® in subjects with RA [ Time Frame: 1.5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TL011 in Severe, Active Rheumatoid Arthritis Patients
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to determine the safety and pharmacology of TL011 in patients with severe rheumatoid arthritis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: TL011
    TL011 infusions
    Intervention: Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis
  • Active Comparator: MabThera
    MabThera infusions
    Intervention: Biological: MabThera infusions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2012)
48
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2010)
60
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Hungary,   Italy,   Spain,   United Kingdom
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT01123070
Other Study ID Numbers  ICMJE RA-TL011-101
2009-015702-18 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries
Study Sponsor  ICMJE Teva Pharmaceutical Industries
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Teva Pharmaceutical Industries
Verification Date May 2012

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