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Completed

NCT Number: NCT01123070

TL011 in Severe, Active Rheumatoid Arthritis Patients

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Teva Investigational Site 5428, Pilsen, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TL011, anti CD20, for the treatment of rheumatoid arthritis

Biological

TL011 administered by 2 infusions, 2 weeks apart

MabThera infusions

Biological

MabThera, administered by 2 infusions, 2 weeks apart

Primary outcomes

  1. Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B

    Time frame: Day 1 to Day 57

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Teva Pharmaceutical Industries, Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 14, 2010
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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