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NCT01405196 · ClinicalTrials.gov registry record · Phase 2
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 183
- Enrollment target
NCT01405196: Completed Phase 2 study, sponsored by Pfizer.
NCT01405196 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 183 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01405196, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 183 participants
- Enrollment target
Study 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.
Primary Outcome
SRI components include:Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),British Isles Lupus Assessment Group(BILAG) 2004,Physician's Global Assessment(PhGA).Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: greater than or equal to(\>=) 4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (less than \[\<\] 0.3 point increase) in PhGA
Interventions
- BIOLOGICAL PF-04236921
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
What the finished NCT01405196 record still lists
NCT01405196 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 1 intervention - of which PF-04236921 is the first listed.
NCT01405196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01405196 about?
NCT01405196 is a clinical study titled "Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus". 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.
What is the current status of trial NCT01405196?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 183 participants. The study started on 2011-12. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01405196?
The interventions under investigation include: PF-04236921 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01405196?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01405196's enrollment target sits among peer trials
183 363rd of 2000 higher than 1,638 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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