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

November 7, 2013 updated by: Pfizer

Randomized, Parallel, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • C.a.b.a, Argentina, C1055AAF
        • Pfizer Investigational Site
      • C.a.b.a, Argentina, C1425EKG
        • Pfizer Investigational Site
    • C.a.b.a.
      • Buenos Aires, C.a.b.a., Argentina, C1015ABO
        • Pfizer Investigational Site
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Pfizer Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M9L 3A2
        • Pfizer Investigational Site
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Pfizer Investigational Site
  • Chile
    • Santiago
      • Providencia, Santiago, Chile, 7601126
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, 1023
        • Pfizer Investigational Site
      • Gyula, Hungary, 5701
        • Pfizer Investigational Site
      • Miskolc, Hungary, 3529
        • Pfizer Investigational Site
      • Szolnok, Hungary, 5000
        • Pfizer Investigational Site
  • Japan
      • Aichi, Japan
        • Pfizer Investigational Site
      • Fukui, Japan
        • Pfizer Investigational Site
      • Fukuoka, Japan
        • Pfizer Investigational Site
      • Hokkaido, Japan
        • Pfizer Investigational Site
      • Hyogo, Japan
        • Pfizer Investigational Site
      • Kanagawa, Japan
        • Pfizer Investigational Site
      • Miyagi, Japan
        • Pfizer Investigational Site
      • Saitama, Japan
        • Pfizer Investigational Site
      • Shizuoka, Japan
        • Pfizer Investigational Site
      • Tokyo, Japan
        • Pfizer Investigational Site
  • Mexico
    • Torreon
      • Coahulia, Torreon, Mexico, 27000
        • Pfizer Investigational Site
  • Poland
      • Dzialdowo, Poland, 13-200
        • Pfizer Investigational Site
      • Elblag, Poland, 82-300
        • Pfizer Investigational Site
      • Sopot, Poland, 81-759
        • Pfizer Investigational Site
      • Warsawa, Poland, 02-637
        • Pfizer Investigational Site
      • Warszawa, Poland, 04-141
        • Pfizer Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Pfizer Investigational Site
      • Niska Banja, Serbia, 18205
        • Pfizer Investigational Site
      • Novi Sad, Serbia, 21000
        • Pfizer Investigational Site
  • Spain
      • A Coruña, Spain, 15006
        • Pfizer Investigational Site
      • Madrid, Spain, 28007
        • Pfizer Investigational Site
      • Madrid, Spain, 28046
        • Pfizer Investigational Site
      • Sevilla, Spain, 41009
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Paradise Valley, Arizona, United States, 85253
        • Pfizer Investigational Site
    • California
      • Palm Desert, California, United States, 92260
        • Pfizer Investigational Site
      • Santa Monica, California, United States, 90404
        • Pfizer Investigational Site
      • Westlake Village, California, United States, 91361
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, United States, 33169
        • Pfizer Investigational Site
      • Palm Harbor, Florida, United States, 34684
        • Pfizer Investigational Site
    • Illinois
      • Springfield, Illinois, United States, 62704
        • Pfizer Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01610
        • Pfizer Investigational Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Pfizer Investigational Site
    • New York
      • Syracuse, New York, United States, 13210
        • Pfizer Investigational Site
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Pfizer Investigational Site
    • Ohio
      • Dayton, Ohio, United States, 45408
        • Pfizer Investigational Site
      • Toledo, Ohio, United States, 43606
        • Pfizer Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Pfizer Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Pfizer Investigational Site
    • West Virginia
      • Clarksburg, West Virginia, United States, 26301
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group 1
Drug: SBI-087
200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
Drug: SBI-087
200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate
Drug: SBI-087
200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate
Drug: SBI-087
200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate
Experimental: Treatment Group 2
Drug: SBI-087
200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
Drug: SBI-087
200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate
Drug: SBI-087
200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate
Drug: SBI-087
200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate
Experimental: Treatment Group 3
Drug: SBI-087
200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
Drug: SBI-087
200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate
Drug: SBI-087
200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate
Drug: SBI-087
200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate
Placebo Comparator: Treatment Group 5
Drug: Placebo
Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
Experimental: Treatment Group 4
Drug: SBI-087
200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
Drug: SBI-087
200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate
Drug: SBI-087
200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate
Drug: SBI-087
200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response as measured by American College of Rheumatology criteria (ACR 20 response)
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: up to 24 weeks
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Emergent Product Development Seattle LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (Estimate)

November 6, 2009

Study Record Updates

Last Update Posted (Estimate)

December 3, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3227K1-2000
  • B2261003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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