TL011 in Severe, Active Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123070
• Other study ID #: RA-TL011-101
• Secondary ID: 2009-015702-18
• Status: Completed
• Phase: Phase 1
• Start date: February 5, 2010
• Est. completion date: April 23, 2012

Study information

• Verified date: September 2021
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 23, 2012
• Est. primary completion date: April 23, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• TL011, anti CD20, for the treatment of rheumatoid arthritis
TL011 administered by 2 infusions, 2 weeks apart
• MabThera infusions
MabThera, administered by 2 infusions, 2 weeks apart

Locations

Country	Name	City	State
Czechia	Teva Investigational Site 5428	Plzen
Czechia	Teva Investigational Site 5426	Prague 2
Czechia	Teva Investigational Site 5429	Uherske Hradiste
Hungary	Teva Investigational Site 5122	Budapest
Hungary	Teva Investigational Site 5123	Budapest
Hungary	Teva Investigational Site 5125	Debrecen
Hungary	Teva Investigational Site 5124	Szeged
Italy	Teva Investigational Site 3077	Firenze
Italy	Teva Investigational Site 3075	Genova
Italy	Teva Investigational Site 3078	Pavia
Italy	Teva Investigational Site 3076	Siena
Spain	Teva Investigational Site 3170	Barakaldo
Spain	Teva Investigational Site 3168	Guadalajara
Spain	Teva Investigational Site 3167	Madrid
Spain	Teva Investigational Site 3169	Sevilla
United Kingdom	Teva Investigational Site 3434	Manchester
United Kingdom	Teva Investigational Site 3433	Staffordshire
United Kingdom	Teva Investigational Site 3435	Wirral, Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries, Ltd.

Countries where clinical trial is conducted

Czechia,  Hungary,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B		Day 1 to Day 57
Secondary	Maximum Observed Concentration (Cmax) in Part B		Day 1 to Day 57
Secondary	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.	From randomization up to Week 24
Secondary	Cmax Post First Dose (C1max) and Post Second Dose (C2max) in Part B		Day 1, Day 15
Secondary	AUC At First Dose (AUC1) and AUC At Second Dose (AUC2) in Part B		Day 1, Day 15
Secondary	Percent Change From Baseline in CD19+ B-cell Count in Part B		Baseline to Day 57
Secondary	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])	Baseline to Day 57
Secondary	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.	Day 1 to Day 57
Secondary	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.	From randomization up to Week 24