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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00883896
First received: April 17, 2009
Last updated: November 12, 2012
Last verified: November 2012

April 17, 2009
November 12, 2012
June 2009
February 2011   (final data collection date for primary outcome measure)
American College of Rheumatology (ACR) 20% improvement criteria [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00883896 on ClinicalTrials.gov Archive Site
ACR20 at other time points, ACR50, ACR70, DAS28, EULAR response, tender and swollen joints assessments, physician and patient global assessments, Pain Visual Analog Scale, health outcome assessments [ Time Frame: Up to Week 22 ] [ Designated as safety issue: No ]
ACR20 other time points, ACR50, ACR70, DAS28, EULAR response, tender and swollen joints assessments, physician and patient global assessments, Pain Visual Analog Scale, health outcome assessments [ Time Frame: Up to Week 22 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   United States,   Russian Federation,   Colombia,   Croatia,   Germany,   Hungary,   Japan,   Mexico,   Netherlands,   Romania
 
NCT00883896
3199K1-2001, B1981001
No
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