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
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Other: Placebo
Drug: ILV-094
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • American College of Rheumatology (ACR) 20% improvement criteria [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 195
Study Start Date: June 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883896

  Show 49 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00883896     History of Changes
Other Study ID Numbers: 3199K1-2001, B1981001
Study First Received: April 17, 2009
Last Updated: November 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Rheumatoid Arthritis
ACR
Methotrexate
Interleukin-22

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014