At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 54 enrolled
Drug / intervention
TL011, anti CD20, for the treatment of rheumatoid arthritis +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase Ib Study Evaluating Safety, Pharmacokinetic and Pharmacodynamic Profiles of a Single Course of TL011 Infusions in Subjects With Severe, Active Rheumatoid Arthritis
In Brief
A Phase 1 clinical trial evaluating TL011, anti CD20, for the treatment of rheumatoid arthritis and MabThera infusions for Rheumatoid Arthritis. Completed, enrolled 54 participants across 18 sites in 5 countries.
Detailed Summary
The purpose of this study is to determine the safety and pharmacology of TL011 in patients with severe rheumatoid arthritis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesCzechia, Hungary, Italy, Spain, United Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedMay 2010
Primary CompletionApr 2012
TodayJul 2026
First PostedMay 14, 2010
Enrollment StartFeb 5, 2010
Primary CompletionApr 23, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.1 years ago
Interventions
TL011, anti CD20, for the treatment of rheumatoid arthritisbiological
TL011 administered by 2 infusions, 2 weeks apart
MabThera infusionsbiological
MabThera, administered by 2 infusions, 2 weeks apart