TL011 in Severe, Active Rheumatoid Arthritis Patients

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis; Biological: MabThera infusions

• Registration Number: NCT01123070
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-05
• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-14
• Primary Completion: 2012-04-23
• Study Completion: 2012-04-23
• Results First Submitted: 2021-07-22
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-07
• Last Update Submitted: 2021-09-07
• Results First Posted: 2021-10-04
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TL011	TL011, anti CD20, for the treatment of rheumatoid arthritis	TL011 infusions
MabThera	MabThera infusions	MabThera infusions

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B	Day 1 to Day 57

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events in Part B	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.
Cmax Post First Dose (C1max) and Post Second Dose (C2max) in Part B	Day 1, Day 15
Maximum Observed Concentration (Cmax) in Part B	Day 1 to Day 57
AUC At First Dose (AUC1) and AUC At Second Dose (AUC2) in Part B	Day 1, Day 15
Number of Participants With American College of Rheumatology (ACR20) Criteria Response in Part B	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 \[CRP\])
Area Under the Plasma Concentration Versus Time Curve [AUC (0-t)] for Part A Cohort 2	Day 1 to Day 57	Data available for cohort 2 only per planned analysis.
Percent Change From Baseline in CD19+ B-cell Count in Part B	Baseline to Day 57
Number of Participants With Adverse Events in Part A	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.

Trial Locations

Locations (18)

Teva Investigational Site 5428; 🇨🇿 Plzen, Czechia

Teva Investigational Site 5426; 🇨🇿 Prague 2, Czechia

Teva Investigational Site 5429; 🇨🇿 Uherske Hradiste, Czechia

Teva Investigational Site 5123; 🇭🇺 Budapest, Hungary

Teva Investigational Site 5122; 🇭🇺 Budapest, Hungary

Teva Investigational Site 5124; 🇭🇺 Szeged, Hungary

Teva Investigational Site 3077; 🇮🇹 Firenze, Italy

Teva Investigational Site 3075; 🇮🇹 Genova, Italy

Teva Investigational Site 3078; 🇮🇹 Pavia, Italy

Teva Investigational Site 3076; 🇮🇹 Siena, Italy

Teva Investigational Site 3170; 🇪🇸 Barakaldo, Spain

Teva Investigational Site 3168; 🇪🇸 Guadalajara, Spain

Teva Investigational Site 3167; 🇪🇸 Madrid, Spain

Teva Investigational Site 3169; 🇪🇸 Sevilla, Spain

Teva Investigational Site 3434; 🇬🇧 Manchester, United Kingdom

Teva Investigational Site 3433; 🇬🇧 Staffordshire, United Kingdom

Teva Investigational Site 3435; 🇬🇧 Wirral, Merseyside, United Kingdom

Teva Investigational Site 5125; 🇭🇺 Debrecen, Hungary