Trials / Completed
CompletedNCT01123070
TL011 in Severe, Active Rheumatoid Arthritis Patients
A Phase Ib Study Evaluating Safety, Pharmacokinetic and Pharmacodynamic Profiles of a Single Course of TL011 Infusions in Subjects With Severe, Active Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Teva Pharmaceutical Industries, Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety and pharmacology of TL011 in patients with severe rheumatoid arthritis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TL011, anti CD20, for the treatment of rheumatoid arthritis | TL011 administered by 2 infusions, 2 weeks apart |
| BIOLOGICAL | MabThera infusions | MabThera, administered by 2 infusions, 2 weeks apart |
Timeline
- Start date
- 2010-02-05
- Primary completion
- 2012-04-23
- Completion
- 2012-04-23
- First posted
- 2010-05-14
- Last updated
- 2021-10-04
- Results posted
- 2021-10-04
Locations
18 sites across 5 countries: Czechia, Hungary, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01123070. Inclusion in this directory is not an endorsement.