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NCT Number: NCT01008852

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

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.

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Key information

Conditions

Active Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Buenos Aires, C.a.b.a., Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SBI-087

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: 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

    Time frame: up to 24 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Emergent Product Development Seattle LLC

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Nov 6, 2009
Registry last updated
Dec 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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