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

NCT ID: NCT01008852

Last Updated: 2013-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-07-31

Brief Summary

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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

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Conditions

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Active Rheumatoid Arthritis

Keywords

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rheumatoid arthritis seropositive methotrexate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment Group 1

Group Type EXPERIMENTAL

SBI-087

Intervention Type DRUG

200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate

Treatment Group 2

Group Type EXPERIMENTAL

SBI-087

Intervention Type DRUG

200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate

Treatment Group 3

Group Type EXPERIMENTAL

SBI-087

Intervention Type DRUG

200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate

Treatment Group 4

Group Type EXPERIMENTAL

SBI-087

Intervention Type DRUG

200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate

Treatment Group 5

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate

Interventions

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SBI-087

200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate

Intervention Type DRUG

SBI-087

200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate

Intervention Type DRUG

SBI-087

200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate

Intervention Type DRUG

SBI-087

200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate

Intervention Type DRUG

Placebo

Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emergent Product Development Seattle LLC

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Paradise Valley, Arizona, United States

Site Status

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Palm Desert, California, United States

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Santa Monica, California, United States

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Westlake Village, California, United States

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Newark, Delaware, United States

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Miami, Florida, United States

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Palm Harbor, Florida, United States

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Springfield, Illinois, United States

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Worcester, Massachusetts, United States

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Grand Rapids, Michigan, United States

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Albuquerque, New Mexico, United States

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Syracuse, New York, United States

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Minot, North Dakota, United States

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Dayton, Ohio, United States

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Toledo, Ohio, United States

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Tulsa, Oklahoma, United States

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Charleston, South Carolina, United States

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Jackson, Tennessee, United States

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Spokane, Washington, United States

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Clarksburg, West Virginia, United States

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Buenos Aires, C.a.b.a., Argentina

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C.a.b.a, , Argentina

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C.a.b.a, , Argentina

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Winnipeg, Manitoba, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Pointe-Claire, Quebec, Canada

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Providencia, Santiago Metropolitan, Chile

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Budapest, , Hungary

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Gyula, , Hungary

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Miskolc, , Hungary

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Szolnok, , Hungary

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Aichi, , Japan

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Fukui, , Japan

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Fukuoka, , Japan

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Hokkaido, , Japan

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Hyōgo, , Japan

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Kanagawa, , Japan

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Miyagi, , Japan

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Saitama, , Japan

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Shizuoka, , Japan

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Tokyo, , Japan

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Coahulia, Torreon, Mexico

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Warsaw, Poland, Poland

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Działdowo, , Poland

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Elblag, , Poland

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Sopot, , Poland

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Warsaw, , Poland

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Belgrade, , Serbia

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Niška Banja, , Serbia

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Novi Sad, , Serbia

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A Coruña, A Coruña, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Seville, Sevilla, Spain

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Countries

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Greece Turkey (Türkiye) United States Argentina Canada Chile Hungary Japan Mexico Poland Serbia Spain

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3227K1-2000&StudyName=Study%20Evaluating%20The%20Efficacy%20And%20Safety%20Of%20SBI-087%20In%20Seropositive%20Subjects%20With%20Active%20Rheumatoid%20Arthritis

To obtain contact information for a study center near you, click here.

Other Identifiers

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B2261003

Identifier Type: -

Identifier Source: secondary_id

3227K1-2000

Identifier Type: -

Identifier Source: org_study_id