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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00883896
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : November 19, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Placebo Drug: ILV-094 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Arm 1
Part 1: Placebo
Other: Placebo
Part 1: Placebo SC administration every 2 weeks X 10 weeks.

Experimental: Arm 2
Part 1: 100 mg ILV-094 SC Q4W
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.

Experimental: Arm 3
Part 1: 100 mg ILV-094 SC Q2W
Drug: ILV-094
Part 1: ILV-094 100 mg SC every 2 weeks X 10 weeks.

Placebo Comparator: Arm 4 Other: Placebo
Part 2: Placebo SC administration every 2 weeks X 10 weeks

Experimental: Arm 5
Part 2: 200 mg ILV-094 SC Q2W
Drug: ILV-094
Part 2: ILV-094 200 mg SC every 2 weeks X 10 weeks

Primary Outcome Measures :
  1. American College of Rheumatology (ACR) 20% improvement criteria [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00883896

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT00883896    
Other Study ID Numbers: 3199K1-2001
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: November 19, 2012
Last Verified: November 2012
Keywords provided by Pfizer:
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dermatologic Agents