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Trial record 1 of 1 for:    NCT01008852
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Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 5, 2009
First Posted Date  ICMJE November 6, 2009
Last Update Posted Date December 3, 2013
Study Start Date  ICMJE December 2009
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
Response as measured by American College of Rheumatology criteria (ACR 20 response) [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01008852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • Drug: SBI-087
    200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
  • Drug: SBI-087
    200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate
  • Drug: SBI-087
    200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate
  • Drug: SBI-087
    200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate
  • Drug: Placebo
    Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
Study Arms  ICMJE
  • Experimental: Treatment Group 1
    Intervention: Drug: SBI-087
  • Experimental: Treatment Group 2
    Intervention: Drug: SBI-087
  • Experimental: Treatment Group 3
    Intervention: Drug: SBI-087
  • Experimental: Treatment Group 4
    Intervention: Drug: SBI-087
  • Placebo Comparator: Treatment Group 5
    Intervention: Drug: Placebo
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
 (submitted: August 27, 2013)
210
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2009)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Pfizer CT.gov Call Center Pfizer
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