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

NCT00883896

CompletedPhase 2

Sponsor: Pfizer

Conditions: Rheumatoid Arthritis

Interventions: Placebo, ILV-094, ILV-094, Placebo, ILV-094

Countries: United States, Belgium, Colombia, Croatia, Germany, Hungary, Japan, Mexico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (52)
  • Glendale, Arizona, United States
  • Palm Desert, California, United States
  • Palm Harbor, Florida, United States
  • Sarasota, Florida, United States
  • Sarasota, Florida, United States
  • Indianapolis, Indiana, United States
  • St Louis, Missouri, United States
  • Cincinnati, Ohio, United States
  • Duncansville, Pennsylvania, United States
  • West Reading, Pennsylvania, United States
  • Wyomissing, Pennsylvania, United States
  • Dallas, Texas, United States
  • San Antonio, Texas, United States
  • Antwerp, Belgium
  • Brussels, Belgium
  • Ghent, Belgium
  • Hasselt, Belgium
  • Liège, Belgium
  • Barranquilla, Atlántico, Colombia
  • Bogota, Cundinamarca, Colombia
  • Bucaramanga, Santander Department, Colombia
  • Bucaramanga, Santander Department, Colombia
  • Rijeka, Croatia
  • Zagreb, Croatia
  • München, Germany
  • Budapest, Hungary
  • Budapest, Hungary
  • Nyíregyháza, Hungary
  • Szombathely, Hungary
  • Yotsukaidou, Chiba, Japan
  • + 22 more on CT.gov