Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis

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NCT00883896

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Study Location
Pfizer Investigational Site
Glendale, Arizona, 85304, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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 at the time of screening and baseline consisting of >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following at screening: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h

- Must be receiving methotrexate for at least 12 weeks, with a stable route and dose (up to 25 mg weekly) for at least 8 weeks prior to the baseline visit.

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


- Subjects with other rheumatic diseases


- Cancer or history of cancer (other than cutaneous basal cell carcinoma and squamous
cell carcinoma or in situ cervical cancer)


- Any prior use of B cell-depleting therapy

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis
Official Title  ICMJE A Randomized, Parallel, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of ILV-094 Administered Subcutaneously To Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate
Brief Summary The primary objective of this study is to assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking 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 Rheumatoid Arthritis
Intervention  ICMJE
  • Other: Placebo
    Part 1: Placebo SC administration every 2 weeks X 10 weeks.
  • Drug: ILV-094
    Part 1: ILV-094 100 mg SC every 4 weeks (alternating ILV-094 100 mg and placebo every 2 weeks) X 10 weeks.
  • Drug: ILV-094
    Part 1: ILV-094 100 mg SC every 2 weeks X 10 weeks.
  • Other: Placebo
    Part 2: Placebo SC administration every 2 weeks X 10 weeks
  • Drug: ILV-094
    Part 2: ILV-094 200 mg SC every 2 weeks X 10 weeks
Study Arms  ICMJE
  • Placebo Comparator: Arm 1
    Part 1: Placebo
    Intervention: Other: Placebo
  • Experimental: Arm 2
    Part 1: 100 mg ILV-094 SC Q4W
    Intervention: Drug: ILV-094
  • Experimental: Arm 3
    Part 1: 100 mg ILV-094 SC Q2W
    Intervention: Drug: ILV-094
  • Placebo Comparator: Arm 4
    Intervention: Other: Placebo
  • Experimental: Arm 5
    Part 2: 200 mg ILV-094 SC Q2W
    Intervention: Drug: ILV-094
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: October 11, 2010)		195
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2009)		120
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 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 at the time of screening and baseline consisting of >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following at screening: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h
  • Must be receiving methotrexate for at least 12 weeks, with a stable route and dose (up to 25 mg weekly) for at least 8 weeks prior to the baseline visit.

Exclusion Criteria:

  • Subjects with other rheumatic diseases
  • Cancer or history of cancer (other than cutaneous basal cell carcinoma and squamous cell carcinoma or in situ cervical cancer)
  • 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 Belgium,   Colombia,   Croatia,   Germany,   Hungary,   Japan,   Mexico,   Netherlands,   Romania,   Russian Federation,   United States
Removed Location Countries Denmark
 
Administrative Information
NCT Number  ICMJE NCT00883896
Other Study ID Numbers  ICMJE 3199K1-2001
B1981001
Has Data Monitoring Committee No
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 November 2012

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