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

NCT01008852 | Completed Phase 2 DMC

• 2 other identifiers: 3227K1-2000B2261003
• Study Type: interventional
• Target: 210
• Locations: 10 countries
• Sites: 55

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.

Conditions

Active Rheumatoid Arthritis

Keywords

rheumatoid arthritis; seropositive; methotrexate

Outcome Measures

Primary Outcomes (1)

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

  16 weeks

Secondary Outcomes (1)

• 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

Study Arms (5)

Treatment Group 1

EXPERIMENTAL

Drug: SBI-087

Treatment Group 2

EXPERIMENTAL

Drug: SBI-087

Treatment Group 3

EXPERIMENTAL

Drug: SBI-087

Treatment Group 4

EXPERIMENTAL

Drug: SBI-087

Treatment Group 5

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SBI-087 DRUG

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

Treatment Group 1

Placebo DRUG

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

Treatment Group 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead
• Emergent Product Development Seattle LLC: collaborator

Study Sites (55)

Pfizer Investigational Site

Paradise Valley, Arizona, 85253, United States

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Palm Desert, California, 92260, United States

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Santa Monica, California, 90404, United States

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Westlake Village, California, 91361, United States

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Newark, Delaware, 19713, United States

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Miami, Florida, 33169, United States

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Palm Harbor, Florida, 34684, United States

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Springfield, Illinois, 62704, United States

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Worcester, Massachusetts, 01610, United States

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Grand Rapids, Michigan, 49546, United States

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Albuquerque, New Mexico, 87102, United States

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Syracuse, New York, 13210, United States

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Minot, North Dakota, 58701, United States

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Dayton, Ohio, 45408, United States

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Toledo, Ohio, 43606, United States

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Tulsa, Oklahoma, 74135, United States

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Charleston, South Carolina, 29406, United States

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Jackson, Tennessee, 38305, United States

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Spokane, Washington, 99204, United States

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Clarksburg, West Virginia, 26301, United States

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Buenos Aires, C.a.b.a., C1015ABO, Argentina

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C.a.b.a, C1055AAF, Argentina

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C.a.b.a, C1425EKG, Argentina

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Winnipeg, Manitoba, R3A 1M3, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Toronto, Ontario, M9L 3A2, Canada

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Pointe-Claire, Quebec, H9R 3J1, Canada

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Providencia, Santiago Metropolitan, 7601126, Chile

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Budapest, 1023, Hungary

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Gyula, 5701, Hungary

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Miskolc, 3529, Hungary

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Szolnok, 5000, 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, 27000, Mexico

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Warsaw, Poland, 04-141, Poland

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Działdowo, 13-200, Poland

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Elblag, 82-300, Poland

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Sopot, 81-759, Poland

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Warsaw, 02-637, Poland

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Belgrade, 11000, Serbia

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Niška Banja, 18205, Serbia

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Novi Sad, 21000, Serbia

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A Coruña, A Coruña, 15006, Spain

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Madrid, Madrid, 28007, Spain

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Madrid, Madrid, 28046, Spain

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Pfizer Investigational Site

Seville, Sevilla, 41009, Spain

Location

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

SBI-087

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: December 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: July 1, 2013
• Last Updated: December 3, 2013

Record last verified: 2013-11

Locations

ME (1); JP (10); PL (5); ES (4); CA (4); US (20); AR (3); HU (4); CL (1); SE (3)