Status:
COMPLETED
Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis
Lead Sponsor:
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 art...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 18 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2011
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00883896
Start Date
June 18 2009
End Date
February 18 2011
Last Update
October 21 2022
Active Locations (52)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, United States, 85304
2
Desert Medical Advances
Palm Desert, California, United States, 92260
3
Arthritis Center
Palm Harbor, Florida, United States, 34684
4
Clinical Research Advantage, Inc.
Sarasota, Florida, United States, 34233