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.

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