A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis.
18 Years
N/A
Both
Rheumatoid Arthritis
Trial Information
A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis.
The treatment period starts with a 12-week, double-blind, placebo-controlled, randomized
period followed by an open-label extension phase. In the double-blind phase, eligible
patients are randomized (4:1 ratio) to receive either certolizumab pegol (CZP) or Placebo up
to and including Week 10. The randomization will be stratified according to the three
factors: concomitant use of methotrexate (MTX, Yes or No), prior anti-tumor necrosis factor
(anti-TNF) use (Yes or No), and disease duration categories (< 2 years or ≥ 2 years). From
Week 12 all patients remaining in the study receive open-label CZP for a minimum 16
additional weeks until CZP is commercially available.
Inclusion Criteria:
- Adult patient with established moderate to severe rheumatoid arthritis
Exclusion Criteria:
- All concomitant diseases or pathological conditions that could interfere and impact
the assessment of the study treatment
- Previous clinical trials and previous biological therapy that could interfere with
the results in the present clinical trials
Type of Study:
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
Outcome Measure:
American College of Rheumatology 20% (ACR20) Response at Week 12
Outcome Description:
ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Outcome Time Frame:
Baseline, Week 12
Safety Issue:
No
Principal Investigator
UCB Clinical Trial Call Center
Investigator Role:
Study Director
Investigator Affiliation:
+1 877 822 9493 (UCB)
Authority:
United States: Food and Drug Administration
Study ID:
C87094
NCT ID:
NCT00717236
Start Date:
July 2008
Completion Date:
March 2011
Related Keywords:
- Rheumatoid Arthritis
- Certolizumab pegol
- Cimzia
- Rheumatoid Arthritis
- Joint Disease
- Chronic Arthritis
- Arthritis
- Arthritis, Rheumatoid
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Alexandria, Minnesota 56308 | |
| Albany, Georgia 31701 | |
| Birmingham, Alabama 35294 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| Louisville, Kentucky 40207 | |
| McLean, Virginia 22101 | |
| Little Rock, Arkansas 72205-7199 | |
| Kansas City, Kansas 66160 | |
| Hackensack, New Jersey 07601 | |
| Metairie, Louisiana 70006 | |
| Denver, Colorado | |
| Baltimore, Maryland 21287 | |
| Boston, Massachusetts | |
| Charlotte, North Carolina | |
| Milwaukee, Wisconsin | |
| Wilmington, Delaware | |
| Indianapolis, Indiana | |
| Charleston, South Carolina | |
| Tulsa, Oklahoma | |
| Charleston, West Virginia 25304 | |
| Washington, District of Columbia | |
| Salt Lake City, Utah 84112 | |
| Coeur D'alene, Idaho 83814 |
