Trials / Completed
CompletedNCT01405196
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 183 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PF-04236921 | subcutaneous injection; administered at day 1, weeks 8, 16. |
| BIOLOGICAL | PF-04236921 | subcutaneous injection; administered at day 1, weeks 8, 16. |
| BIOLOGICAL | PF-04236921 | subcutaneous injection; administered at day 1, weeks 8, 16. |
| BIOLOGICAL | PF-04236921 | subcutaneous injection; administered at day 1, weeks 8, 16 |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2014-03-01
- Completion
- 2014-03-01
- First posted
- 2011-07-29
- Last updated
- 2017-12-19
- Results posted
- 2017-12-19
Locations
113 sites across 13 countries: United States, Argentina, Chile, Colombia, Germany, Hungary, Moldova, Peru, Poland, Puerto Rico, Romania, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT01405196. Inclusion in this directory is not an endorsement.