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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Paradise Valley, Arizona, 85253 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Active Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any significant health problem other than rheumatoid arthritis

- Any clinically significant laboratory abnormalities

- Any prior use of B cell-depleting therapy

NCT01008852
Pfizer
Completed
Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis

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Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Active Rheumatoid Arthritis
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
July 2013
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Canada,   Chile,   Hungary,   Japan,   Mexico,   Poland,   Serbia,   Spain,   United States
Greece,   Turkey
 
NCT01008852
3227K1-2000
B2261003
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Emergent Product Development Seattle LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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