Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus

NCT01405196

Last updated date
Study Location
Anniston Medical Clinic, PC
Anniston, Alabama, 36207, United States
Contact
1-800-718-1021

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By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Systemic Lupus Erythematosus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects between ages of 18 and 75 years old at time of signing consent.

- Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American College of Rheumatology (ACR) criteria.

- Have a unequivocally positive anti-nuclear antibody (ANA) test result.

- Active disease at screening defined by both: SLEDAI-2K score greater than or equal to 6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or central nervous system) or BILAG B disease in more than or equal to 2 organ systems if no level A disease in present.

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


- Any prior history of treatment with PF-04236921, or anti-IL-6 agent;


- Have received any of the following within 364 days of day 1: a biologic
investigational agent other than B cell targeted therapy; required 3 or more courses
of systemic corticosteroids for concomitant conditions; history of previously
untreated or current evidence of active or untreated latent infection with
Tuberculosis (TB), evidence of prior untreated or currently active TB by chest
radiography, residing with or frequent close contact with an individual with active
TB.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
Official Title  ICMJE A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)
Brief Summary The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.
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 Lupus Erythematosus, Systemic
Intervention  ICMJE
  • Biological: PF-04236921
    subcutaneous injection; administered at day 1, weeks 8, 16.
  • Biological: PF-04236921
    subcutaneous injection; administered at day 1, weeks 8, 16
Study Arms  ICMJE
  • 10 mg of PF-04236921
    Intervention: Biological: PF-04236921
  • 50 mg of PF-04236921
    Intervention: Biological: PF-04236921
  • 200 mg of PF-04236921
    Intervention: Biological: PF-04236921
  • Placebo
    Intervention: Biological: PF-04236921
Publications *

*   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: April 11, 2014)
183
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2011)
180
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects between ages of 18 and 75 years old at time of signing consent.
  • Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American College of Rheumatology (ACR) criteria.
  • Have a unequivocally positive anti-nuclear antibody (ANA) test result.
  • Active disease at screening defined by both: SLEDAI-2K score greater than or equal to 6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or central nervous system) or BILAG B disease in more than or equal to 2 organ systems if no level A disease in present.

Exclusion Criteria:

  • Any prior history of treatment with PF-04236921, or anti-IL-6 agent;
  • Have received any of the following within 364 days of day 1: a biologic investigational agent other than B cell targeted therapy; required 3 or more courses of systemic corticosteroids for concomitant conditions; history of previously untreated or current evidence of active or untreated latent infection with Tuberculosis (TB), evidence of prior untreated or currently active TB by chest radiography, residing with or frequent close contact with an individual with active TB.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (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,   Chile,   Colombia,   Germany,   Hungary,   Korea, Republic of,   Moldova, Republic of,   Peru,   Poland,   Puerto Rico,   Romania,   Taiwan,   United States
Removed Location Countries Mexico
 
Administrative Information
NCT Number  ICMJE NCT01405196
Other Study ID Numbers  ICMJE B0151006
2011-000420-15 ( EudraCT Number )
BUTTERFLY ( Other Identifier: Alias Study Number )
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 Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP