TL011 in Severe, Active Rheumatoid Arthritis Patients

September 7, 2021 updated by: Teva Pharmaceutical Industries, Ltd.

A Phase Ib Study Evaluating Safety, Pharmacokinetic and Pharmacodynamic Profiles of a Single Course of TL011 Infusions in Subjects With Severe, Active Rheumatoid Arthritis

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Plzen, Czechia, 323 00
        • Teva Investigational Site 5428
      • Prague 2, Czechia, 12850
        • Teva Investigational Site 5426
      • Uherske Hradiste, Czechia, 686 01
        • Teva Investigational Site 5429
  • Hungary
      • Budapest, Hungary, 1083
        • Teva Investigational Site 5123
      • Budapest, Hungary, H-1023
        • Teva Investigational Site 5122
      • Debrecen, Hungary, 4032
        • Teva Investigational Site 5125
      • Szeged, Hungary, H-6720
        • Teva Investigational Site 5124
  • Italy
      • Firenze, Italy, 50139
        • Teva Investigational Site 3077
      • Genova, Italy, 16132
        • Teva Investigational Site 3075
      • Pavia, Italy, 27100
        • Teva Investigational Site 3078
      • Siena, Italy, 53100
        • Teva Investigational Site 3076
  • Spain
      • Barakaldo, Spain, 48903
        • Teva Investigational Site 3170
      • Guadalajara, Spain, 19002
        • Teva Investigational Site 3168
      • Madrid, Spain, 28009
        • Teva Investigational Site 3167
      • Sevilla, Spain, 41014
        • Teva Investigational Site 3169
  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Teva Investigational Site 3434
      • Staffordshire, United Kingdom, WS11 5XY
        • Teva Investigational Site 3433
      • Wirral, Merseyside, United Kingdom, CH49 5PE
        • Teva Investigational Site 3435

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B
Time Frame: Day 1 to Day 57
Day 1 to Day 57

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Concentration (Cmax) in Part B
Time Frame: Day 1 to Day 57
Day 1 to Day 57
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.
From randomization up to Week 24
Cmax Post First Dose (C1max) and Post Second Dose (C2max) in Part B
Time Frame: Day 1, Day 15
Day 1, Day 15
AUC At First Dose (AUC1) and AUC At Second Dose (AUC2) in Part B
Time Frame: Day 1, Day 15
Day 1, Day 15
Percent Change From Baseline in CD19+ B-cell Count in Part B
Time Frame: Baseline to Day 57
Baseline to Day 57
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])
Baseline to Day 57
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.
Day 1 to Day 57
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.
From randomization up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Pharmaceutical Industries, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 23, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RA-TL011-101
  • 2009-015702-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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