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

Primary Purpose

Active Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

SBI-087

Placebo

About this trial

This is an interventional treatment trial for Active Rheumatoid Arthritis focused on measuring rheumatoid arthritis, seropositive, methotrexate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group 1

Treatment Group 2

Treatment Group 3

Treatment Group 4

Treatment Group 5

Arm Description

Outcomes

Primary Outcome Measures

Response as measured by American College of Rheumatology criteria (ACR 20 response)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01008852

First Posted

November 5, 2009

Last Updated

November 7, 2013

Sponsor

Pfizer

Collaborators

Emergent Product Development Seattle LLC

1. Study Identification

Unique Protocol Identification Number

NCT01008852

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

Collaborators

Emergent Product Development Seattle LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Active Rheumatoid Arthritis

Keywords

rheumatoid arthritis, seropositive, methotrexate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group 1

Arm Type

Experimental

Arm Title

Treatment Group 2

Arm Type

Experimental

Arm Title

Treatment Group 3

Arm Type

Experimental

Arm Title

Treatment Group 4

Arm Type

Experimental

Arm Title

Treatment Group 5

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

SBI-087

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

SBI-087

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

SBI-087

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

SBI-087

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Response as measured by American College of Rheumatology criteria (ACR 20 response)

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Time Frame

up to 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Paradise Valley

State/Province

Arizona

ZIP/Postal Code

85253

Country

United States

Facility Name

Pfizer Investigational Site

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Pfizer Investigational Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Pfizer Investigational Site

City

Westlake Village

State/Province

California

ZIP/Postal Code

91361

Country

United States

Facility Name

Pfizer Investigational Site

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

Pfizer Investigational Site

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Pfizer Investigational Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Pfizer Investigational Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01610

Country

United States

Facility Name

Pfizer Investigational Site

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49546

Country

United States

Facility Name

Pfizer Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Pfizer Investigational Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Pfizer Investigational Site

City

Minot

State/Province

North Dakota

ZIP/Postal Code

58701

Country

United States

Facility Name

Pfizer Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45408

Country

United States

Facility Name

Pfizer Investigational Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43606

Country

United States

Facility Name

Pfizer Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

Pfizer Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Pfizer Investigational Site

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Pfizer Investigational Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Pfizer Investigational Site

City

Clarksburg

State/Province

West Virginia

ZIP/Postal Code

26301

Country

United States

Facility Name

Pfizer Investigational Site

City

Buenos Aires

State/Province

C.a.b.a.

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

Pfizer Investigational Site

City

C.a.b.a

ZIP/Postal Code

C1055AAF

Country

Argentina

Facility Name

Pfizer Investigational Site

City

C.a.b.a

ZIP/Postal Code

C1425EKG

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1M3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9L 3A2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Pointe-Claire

State/Province

Quebec

ZIP/Postal Code

H9R 3J1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Providencia

State/Province

Santiago

ZIP/Postal Code

7601126

Country

Chile

Facility Name

Pfizer Investigational Site

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Gyula

ZIP/Postal Code

5701

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Aichi

Country

Japan

Facility Name

Pfizer Investigational Site

City

Fukui

Country

Japan

Facility Name

Pfizer Investigational Site

City

Fukuoka

Country

Japan

Facility Name

Pfizer Investigational Site

City

Hokkaido

Country

Japan

Facility Name

Pfizer Investigational Site

City

Hyogo

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kanagawa

Country

Japan

Facility Name

Pfizer Investigational Site

City

Miyagi

Country

Japan

Facility Name

Pfizer Investigational Site

City

Saitama

Country

Japan

Facility Name

Pfizer Investigational Site

City

Shizuoka

Country

Japan

Facility Name

Pfizer Investigational Site

City

Tokyo

Country

Japan

Facility Name

Pfizer Investigational Site

City

Coahulia

State/Province

Torreon

ZIP/Postal Code

27000

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Dzialdowo

ZIP/Postal Code

13-200

Country

Poland

Facility Name

Pfizer Investigational Site

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Pfizer Investigational Site

City

Sopot

ZIP/Postal Code

81-759

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warsawa

ZIP/Postal Code

02-637

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

04-141

Country

Poland

Facility Name

Pfizer Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Pfizer Investigational Site

City

Niska Banja

ZIP/Postal Code

18205

Country

Serbia

Facility Name

Pfizer Investigational Site

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

Pfizer Investigational Site

City

A Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

12. IPD Sharing Statement

Links:

URL

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

Description

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Learn more about this trial

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

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

Active Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial