search
Back to results

TL011 in Severe, Active Rheumatoid Arthritis Patients

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TL011, anti CD20, for the treatment of rheumatoid arthritis
MabThera infusions
Sponsored by
Teva Pharmaceutical Industries, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Teva Investigational Site 5428
  • Teva Investigational Site 5426
  • Teva Investigational Site 5429
  • Teva Investigational Site 5123
  • Teva Investigational Site 5122
  • Teva Investigational Site 5125
  • Teva Investigational Site 5124
  • Teva Investigational Site 3077
  • Teva Investigational Site 3075
  • Teva Investigational Site 3078
  • Teva Investigational Site 3076
  • Teva Investigational Site 3170
  • Teva Investigational Site 3168
  • Teva Investigational Site 3167
  • Teva Investigational Site 3169
  • Teva Investigational Site 3434
  • Teva Investigational Site 3433
  • Teva Investigational Site 3435

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TL011

MabThera

Arm Description

TL011 infusions

MabThera infusions

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maximum Observed Concentration (Cmax) in Part B
Number of Participants With Adverse Events in Part B
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.
Cmax Post First Dose (C1max) and Post Second Dose (C2max) in Part B
AUC At First Dose (AUC1) and AUC At Second Dose (AUC2) in Part B
Percent Change From Baseline in CD19+ B-cell Count in Part B
Number of Participants With American College of Rheumatology (ACR20) Criteria Response in Part B
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])
Area Under the Plasma Concentration Versus Time Curve [AUC (0-t)] for Part A Cohort 2
Data available for cohort 2 only per planned analysis.
Number of Participants With Adverse Events in Part A
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.

Full Information

First Posted
May 11, 2010
Last Updated
September 7, 2021
Sponsor
Teva Pharmaceutical Industries, Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01123070
Brief Title
TL011 in Severe, Active Rheumatoid Arthritis Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 5, 2010 (Actual)
Primary Completion Date
April 23, 2012 (Actual)
Study Completion Date
April 23, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Pharmaceutical Industries, Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TL011
Arm Type
Experimental
Arm Description
TL011 infusions
Arm Title
MabThera
Arm Type
Active Comparator
Arm Description
MabThera infusions
Intervention Type
Biological
Intervention Name(s)
TL011, anti CD20, for the treatment of rheumatoid arthritis
Intervention Description
TL011 administered by 2 infusions, 2 weeks apart
Intervention Type
Biological
Intervention Name(s)
MabThera infusions
Intervention Description
MabThera, administered by 2 infusions, 2 weeks apart
Primary Outcome Measure Information:
Title
Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B
Time Frame
Day 1 to Day 57
Secondary Outcome Measure Information:
Title
Maximum Observed Concentration (Cmax) in Part B
Time Frame
Day 1 to Day 57
Title
Number of Participants With Adverse Events in Part B
Description
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.
Time Frame
From randomization up to Week 24
Title
Cmax Post First Dose (C1max) and Post Second Dose (C2max) in Part B
Time Frame
Day 1, Day 15
Title
AUC At First Dose (AUC1) and AUC At Second Dose (AUC2) in Part B
Time Frame
Day 1, Day 15
Title
Percent Change From Baseline in CD19+ B-cell Count in Part B
Time Frame
Baseline to Day 57
Title
Number of Participants With American College of Rheumatology (ACR20) Criteria Response in Part B
Description
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])
Time Frame
Baseline to Day 57
Title
Area Under the Plasma Concentration Versus Time Curve [AUC (0-t)] for Part A Cohort 2
Description
Data available for cohort 2 only per planned analysis.
Time Frame
Day 1 to Day 57
Title
Number of Participants With Adverse Events in Part A
Description
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.
Time Frame
From randomization up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Teva Investigational Site 5428
City
Plzen
ZIP/Postal Code
323 00
Country
Czechia
Facility Name
Teva Investigational Site 5426
City
Prague 2
ZIP/Postal Code
12850
Country
Czechia
Facility Name
Teva Investigational Site 5429
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Teva Investigational Site 5123
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Teva Investigational Site 5122
City
Budapest
ZIP/Postal Code
H-1023
Country
Hungary
Facility Name
Teva Investigational Site 5125
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Teva Investigational Site 5124
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Teva Investigational Site 3077
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Teva Investigational Site 3075
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Teva Investigational Site 3078
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Teva Investigational Site 3076
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Teva Investigational Site 3170
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Teva Investigational Site 3168
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Teva Investigational Site 3167
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Teva Investigational Site 3169
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Teva Investigational Site 3434
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Teva Investigational Site 3433
City
Staffordshire
ZIP/Postal Code
WS11 5XY
Country
United Kingdom
Facility Name
Teva Investigational Site 3435
City
Wirral, Merseyside
ZIP/Postal Code
CH49 5PE
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

TL011 in Severe, Active Rheumatoid Arthritis Patients

We'll reach out to this number within 24 hrs