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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: SBI-087

Study type: Interventional

Funder types: Industry

Identifiers

NCT00641225

B2261001

3227K1-1000

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

1

Experimental group

Description:

SBI-087

Treatment:

Drug: SBI-087