Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis
NCT01008852
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- 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)
- Any significant health problem other than rheumatoid arthritis
- Any clinically significant laboratory abnormalities
- Any prior use of B cell-depleting therapy
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis | |||
Official Title ICMJE | 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 | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Active Rheumatoid Arthritis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 210 | |||
Original Estimated Enrollment ICMJE | 200 | |||
Actual Study Completion Date ICMJE | July 2013 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Canada, Chile, Hungary, Japan, Mexico, Poland, Serbia, Spain, United States | |||
Removed Location Countries | Greece, Turkey | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01008852 | |||
Other Study ID Numbers ICMJE | 3227K1-2000 B2261003 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Emergent Product Development Seattle LLC | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | November 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |