NCT01288287

Long Term Effects of an Early Response to Certolizumab Pegol (CZP, Cimzia®) in Rheumatoid Arthritis (RA) Patients

A Prospective, Multicentre, Non-interventional, Observational, Cohort Study to Evaluate the Long Term Clinical, Patient Reported and Health Care Resource Utilization Effects of an Early Response to Certolizumab Pegol (Cimzia®) in Rheumatoid Arthritis Patients in Daily Clinical Practice in the United Kingdom and Eire.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 149 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine if early clinical response at 12 weeks to Certolizumab Pegol (CZP, Cimzia ®) therapy in adult Rheumatoid Arthritis (RA) patients is a predictor of better long term clinical response at 18 months compared with a lack of clinical response at 12 weeks.

Detailed description

Clinical response will be assessed by the percentage of patients achieving a reduction from Baseline in Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points, which is considered the minimum clinically important difference.

Conditions

• Arthritis,Rheumatoid

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2011-02-02
• Last updated: 2016-09-16
• Results posted: 2016-06-27

Locations

22 sites across 2 countries: Ireland, United Kingdom