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

Last updated on October 4, 2018

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

NCT00883896
Pfizer
Completed
Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis

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Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
February 2011
February 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 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Colombia,   Croatia,   Germany,   Hungary,   Japan,   Mexico,   Netherlands,   Romania,   Russian Federation,   United States
Denmark
 
NCT00883896
3199K1-2001
B1981001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

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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