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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00883896

Run by

Pfizer

People needed

195

Starts

2009-06-18

Expected to finish

2011-02-18

Last updated by the study team

2022-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Desert Medical Advances — Palm Desert, California, United States
• Arthritis Center — Palm Harbor, Florida, United States
• Clinical Research Advantage, Inc. — Sarasota, Florida, United States
• The Arthritis Specialty Centre — Sarasota, Florida, United States
• Diagnostic Rheumatology and Research PC — Indianapolis, Indiana, United States
• Clayton Medical Research — St Louis, Missouri, United States
• Deaconess Hospital — Cincinnati, Ohio, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Clinical Research Center of Reading — West Reading, Pennsylvania, United States
• Clinical Research Center of Reading, LLC — Wyomissing, Pennsylvania, United States
• Arthritis Care and Diagnostic Center — Dallas, Texas, United States
• Arthritis & Osteoporosis Center of South Texas — San Antonio, Texas, United States
• AZ Jan Palfijn — Antwerp, Belgium
• Cliniques Universitaires St Luc Avenue Hippocrate 10 UCL — Brussels, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Reuma Instituut — Hasselt, Belgium
• Chu Liege Sart Tilman B 35 — Liège, Belgium
• Centro de Reumatologia y Ortopedia — Barranquilla, Atlántico, Colombia
• Fundacion Instituto de Reumatologia Fernando Chalem — Bogota, Cundinamarca, Colombia
• Medicity S.A.S — Bucaramanga, Santander Department, Colombia
• Servimed EU — Bucaramanga, Santander Department, Colombia
• University Hospital Centre Rijeka — Rijeka, Croatia
• University Hospital Center Zagreb — Zagreb, Croatia
• Klinikum Innenstadt der Ludwig-Maximillians-Universität — München, Germany
• Arizona Arthritis & Rheumatology Research, PLLC — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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