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Trial record 4 of 4 for:    SBI-087

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

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ClinicalTrials.gov Identifier: NCT01008852
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : December 3, 2013
Sponsor:
Collaborator:
Emergent Product Development Seattle LLC
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Active Rheumatoid Arthritis Drug: SBI-087 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group 1 Drug: SBI-087
200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate

Experimental: Treatment Group 2 Drug: SBI-087
200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate

Experimental: Treatment Group 3 Drug: SBI-087
200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate

Experimental: Treatment Group 4 Drug: SBI-087
200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate

Placebo Comparator: Treatment Group 5 Drug: Placebo
Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate




Primary Outcome Measures :
  1. Response as measured by American College of Rheumatology criteria (ACR 20 response) [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008852


  Show 55 Study Locations
Sponsors and Collaborators
Pfizer
Emergent Product Development Seattle LLC
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01008852     History of Changes
Other Study ID Numbers: 3227K1-2000
B2261003
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: November 2013

Keywords provided by Pfizer:
rheumatoid arthritis
seropositive
methotrexate

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors