Trials / Completed
CompletedNCT00686868
Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients
Clinical Phase I/IIA Study of Subcutaneously Administration of Ofatumumab in Rheumatoid Arthritis Patients on Stable Dose Methotrexate
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will examine the safety and tolerability, PK and PD of subcutaneously administered GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose escalation/de-escalation phase to investigate the minimal efficacious dose based on PD markers with an acceptable safety profile.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | placebo | placebo |
| DRUG | ofatumumab | fully human anti-CD20 monoclonal antibody |
Timeline
- Start date
- 2008-06-13
- Primary completion
- 2011-03-11
- Completion
- 2011-05-02
- First posted
- 2008-05-30
- Last updated
- 2017-06-26
Locations
17 sites across 9 countries: United States, Australia, Belgium, France, Italy, New Zealand, Poland, Russia, Spain
Source: ClinicalTrials.gov record NCT00686868. Inclusion in this directory is not an endorsement.