Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: SBI-087

• Registration Number: NCT00641225
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to determine the safety and tolerability of single doses of SBI-087 in subjects with rheumatoid arthritis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-24
• Study Start: 2008-03-31
• Primary Completion: 2011-03-31
• Study Completion: 2011-03-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit.
• Must meet criteria for rheumatoid arthritis with functional class I to III.
• Diagnosis of rheumatoid arthritis more than 6 months before study day 1 and rheumatoid arthritis onset after 16 years of age

Exclusion Criteria

• Any significant health problems other than rheumatoid arthritis.
• Treatment of greater than 10 mg of prednisone per day.
• Treatment with cyclophosphamide.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SBI-087	SBI-087

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of ascending single doses of SBI-087 in subjects with rheumatoid arthritis.	12 months

Secondary Outcome Measures

Name	Time	Method
To provide the initial pharmacokinetics and pharmacodynamic profile of SBI-087 in subjects with rheumatoid arthritis.	12 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Montreal, Quebec, Canada