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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
Results First Posted : October 4, 2021
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc. ( Teva Pharmaceutical Industries, Ltd. )

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase Ib Study Evaluating Safety, Pharmacokinetic and Pharmacodynamic Profiles of a Single Course of TL011 Infusions in Subjects With Severe, Active Rheumatoid Arthritis
Actual Study Start Date : February 5, 2010
Actual Primary Completion Date : April 23, 2012
Actual Study Completion Date : April 23, 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. Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B [ Time Frame: Day 1 to Day 57 ]

Secondary Outcome Measures :
  1. Maximum Observed Concentration (Cmax) in Part B [ Time Frame: Day 1 to Day 57 ]
  2. Number of Participants With Adverse Events in Part B [ Time Frame: From randomization up to Week 24 ]
    An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as AEs occurring after the first dose of the study drug until 120 days after the last dose of study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  3. Cmax Post First Dose (C1max) and Post Second Dose (C2max) in Part B [ Time Frame: Day 1, Day 15 ]
  4. AUC At First Dose (AUC1) and AUC At Second Dose (AUC2) in Part B [ Time Frame: Day 1, Day 15 ]
  5. Percent Change From Baseline in CD19+ B-cell Count in Part B [ Time Frame: Baseline to Day 57 ]
  6. Number of Participants With American College of Rheumatology (ACR20) Criteria Response in Part B [ Time Frame: Baseline to Day 57 ]

    Defined as at least 20% improvement from the screening values in swollen and tender joint count and in 3 of the following 5 disease activity measures.

    • Physician's global assessment of disease activity (VAS)
    • Patient's assessment of RA pain (VAS)
    • Patient's global assessment of disease activity
    • Patient's assessment of physical function (Health Assessment Questionnaire)
    • Acute phase reactant (C-reactive protein [CRP])

  7. Area Under the Plasma Concentration Versus Time Curve [AUC (0-t)] for Part A Cohort 2 [ Time Frame: Day 1 to Day 57 ]
    Data available for cohort 2 only per planned analysis.

  8. Number of Participants With Adverse Events in Part A [ Time Frame: From randomization up to Week 24 ]
    An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as AEs occurring after the first dose of the study drug until 120 days after the last dose of study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.



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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, Ltd.
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Responsible Party: Teva Pharmaceutical Industries, Ltd.
ClinicalTrials.gov Identifier: NCT01123070    
Other Study ID Numbers: RA-TL011-101
2009-015702-18 ( EudraCT Number )
First Posted: May 14, 2010    Key Record Dates
Results First Posted: October 4, 2021
Last Update Posted: October 4, 2021
Last Verified: September 2021
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