Study evaluating single doses of SBI-087 in subjects with rheumatoid arthritis (clinicaltrials.gov) - Mar 13, 2012 - P1, N=62; Recruiting -> Completed; Completion date: Jun 2011 -> Mar 2011
Completion date • Trial completion • Immunology • Rheumatoid Arthritis
|
|
This study has been completed.
First Received on March 18, 2008. Last Updated on March 13, 2012 History of Changes
Sponsor: Pfizer
Collaborator: Emergent Product Development Seattle LLC
Information provided by (Responsible Party): Pfizer
ClinicalTrials.gov Identifier: NCT00641225
Purpose
The purpose of this study is to determine the safety and tolerability of single doses of SBI-087 in subjects with rheumatoid arthritis.
Condition
Rheumatoid Arthritis
Intervention
Drug: SBI-087
Phase
Phase I
Study Type: Interventional
Study Design:
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Rheumatoid Arthritis
Resource links provided by NLM:
MedlinePlus related topics: Rheumatoid Arthritis
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures: •To evaluate the safety and tolerability of ascending single doses of SBI-087 in subjects with rheumatoid arthritis. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures: •To provide the initial pharmacokinetics and pharmacodynamic profile of SBI-087 in subjects with rheumatoid arthritis. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Enrollment:62
Study Start Date:March 2008
Study Completion Date:March 2011
Primary Completion Date:March 2011 (Final data collection date for primary outcome measure)
|