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NCT01008852 Clinical Trial

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

Active Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01008852
Other study ID # 3227K1-2000
Secondary ID B2261003
Status Completed
Phase Phase 2
First received November 5, 2009
Last updated November 7, 2013
Start date December 2009
Est. completion date July 2013

Study information
Verified date November 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date July 2013
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SBI-087
200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
• SBI-087
200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate
• SBI-087
200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate
• SBI-087
200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate
• Placebo
Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate

Locations
Country Name City State
Argentina Pfizer Investigational Site Buenos Aires C.a.b.a.
Argentina Pfizer Investigational Site C.a.b.a
Argentina Pfizer Investigational Site C.a.b.a
Canada Pfizer Investigational Site Pointe-Claire Quebec
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Winnipeg Manitoba
Chile Pfizer Investigational Site Providencia Santiago
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Gyula
Hungary Pfizer Investigational Site Miskolc
Hungary Pfizer Investigational Site Szolnok
Japan Pfizer Investigational Site 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
Mexico Pfizer Investigational Site Coahulia Torreon
Poland Pfizer Investigational Site Dzialdowo
Poland Pfizer Investigational Site Elblag
Poland Pfizer Investigational Site Sopot
Poland Pfizer Investigational Site Warsawa
Poland Pfizer Investigational Site Warszawa
Serbia Pfizer Investigational Site Belgrade
Serbia Pfizer Investigational Site Niska Banja
Serbia Pfizer Investigational Site Novi Sad
Spain Pfizer Investigational Site A Coruña
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Sevilla
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Clarksburg West Virginia
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Grand Rapids Michigan
United States Pfizer Investigational Site Jackson Tennessee
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Minot North Dakota
United States Pfizer Investigational Site Newark Delaware
United States Pfizer Investigational Site Palm Desert California
United States Pfizer Investigational Site Palm Harbor Florida
United States Pfizer Investigational Site Paradise Valley Arizona
United States Pfizer Investigational Site Santa Monica California
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Springfield Illinois
United States Pfizer Investigational Site Syracuse New York
United States Pfizer Investigational Site Toledo Ohio
United States Pfizer Investigational Site Tulsa Oklahoma
United States Pfizer Investigational Site Westlake Village California
United States Pfizer Investigational Site Worcester Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Pfizer Emergent Product Development Seattle LLC

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  Hungary,  Japan,  Mexico,  Poland,  Serbia,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response as measured by American College of Rheumatology criteria (ACR 20 response) 16 weeks No
Secondary 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 No
See also
  Status Clinical Trial Phase
Completed NCT04472481 - Vitamin D Effect in Rheumatoid Arthritis. Phase 4
Completed NCT00913458 - Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis Phase 4
Completed NCT00959036 - Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis Phase 1/Phase 2
Completed NCT01961505 - Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis N/A
Completed NCT00393471 - Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis. Phase 3
Not yet recruiting NCT03346590 - Evolution of Total Energy Expenditure and Its Various Components in Active Rheumatoid Arthritis (RA)Treated With Anti-TNF Agents and Comparison With Healthy Subjects N/A
Terminated NCT02534896 - To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis Phase 3
Completed NCT03172325 - Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RA Phase 3
Completed NCT00420199 - A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate Phase 3
Completed NCT00882024 - Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA) Phase 2
Completed NCT03599986 - Clinical Efficacy and Safety of Leflunomide in Egyptian Patients With Active Rheumatoid Arthritis
Completed NCT02586246 - Long-term Treatment Study of CDP870 Self-injection in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870 Phase 3

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