Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Active Rheumatoid Arthritis
• Interventions: Drug: SBI-087; Drug: Placebo

• Registration Number: NCT01008852
• Lead Sponsor: Pfizer

Brief Summary

This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Study Start: 2009-12
• Primary Completion: 2011-09
• Disposition First Submitted: 2012-11-12
• Disposition First Submitted QC: 2013-02-07
• Disposition First Posted: 2013-02-11
• Study Completion: 2013-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
• Active RA as defined by >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h
• Must be seropositive as defined by a documented history of rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positivity
• Must be receiving a stable route and dose of methotrexate (up to 25 mg weekly)

Exclusion Criteria

• Any significant health problem other than rheumatoid arthritis
• Any clinically significant laboratory abnormalities
• Any prior use of B cell-depleting therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	SBI-087	-
Treatment Group 2	SBI-087	-
Treatment Group 3	SBI-087	-
Treatment Group 4	SBI-087	-
Treatment Group 5	Placebo	-

Primary Outcome Measures

Name	Time	Method
Response as measured by American College of Rheumatology criteria (ACR 20 response)	16 weeks

Secondary Outcome Measures

Name	Time	Method
ACR Responses, 28 Joint Assessment, Pain Visual Analog Scale (VAS), General Health VAS, Physician and Patient Global Assessments, Morning Stiffness Duration, FACIT-Fatigue, SF-36, HAQ-DI, Hybrid Measure of ACR, ACR-N, DAS-28 and EULAR response	up to 24 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇪🇸 Sevilla, Spain