Clinical trial NCT01123070: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B
timeFrame: Day 1 to Day 57
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) in Part B
timeFrame: Day 1 to Day 57
measure: Number of Participants With Adverse Events in Part B
timeFrame: From randomization up to Week 24
measure: Cmax Post First Dose (C1max) and Post Second Dose (C2max) in Part B
timeFrame: Day 1, Day 15
measure: AUC At First Dose (AUC1) and AUC At Second Dose (AUC2) in Part B
timeFrame: Day 1, Day 15
measure: Percent Change From Baseline in CD19+ B-cell Count in Part B
timeFrame: Baseline to Day 57
measure: Number of Participants With American College of Rheumatology (ACR20) Criteria Response in Part B
timeFrame: Baseline to Day 57
measure: Area Under the Plasma Concentration Versus Time Curve [AUC (0-t)] for Part A Cohort 2
timeFrame: Day 1 to Day 57
measure: Number of Participants With Adverse Events in Part A
timeFrame: From randomization up to Week 24
Other outcomes:
Locations:
city: Plzen
country: Czechia
facility: Teva Investigational Site 5428
city: Prague 2
country: Czechia
facility: Teva Investigational Site 5426
city: Uherske Hradiste
country: Czechia
facility: Teva Investigational Site 5429
city: Budapest
country: Hungary
facility: Teva Investigational Site 5123
city: Budapest
country: Hungary
facility: Teva Investigational Site 5122
city: Debrecen
country: Hungary
facility: Teva Investigational Site 5125
city: Szeged
country: Hungary
facility: Teva Investigational Site 5124
city: Firenze
country: Italy
facility: Teva Investigational Site 3077
city: Genova
country: Italy
facility: Teva Investigational Site 3075
city: Pavia
country: Italy
facility: Teva Investigational Site 3078
city: Siena
country: Italy
facility: Teva Investigational Site 3076
city: Barakaldo
country: Spain
facility: Teva Investigational Site 3170
city: Guadalajara
country: Spain
facility: Teva Investigational Site 3168
city: Madrid
country: Spain
facility: Teva Investigational Site 3167
city: Sevilla
country: Spain
facility: Teva Investigational Site 3169
city: Manchester
country: United Kingdom
facility: Teva Investigational Site 3434
city: Staffordshire
country: United Kingdom
facility: Teva Investigational Site 3433
city: Wirral, Merseyside
country: United Kingdom
facility: Teva Investigational Site 3435
Study officials:
References: