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

UCB

Status: Completed

Conditions: Arthritis,Rheumatoid

Study type: Observational

Funder types: Industry

Identifiers

NCT01288287

RA0042

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent is signed and dated
• The patient is considered capable of and prepared to adhere to the study protocol procedures
• The patient is prescribed CZP according to the Summary of Product Characteristics (SmPC) (UK and Eire) and National Institute of Clinical Excellence (NICE) (UK only) guidelines for anti tumor necrosis factor (TNF) α therapy for Rheumatoid Arthritis (RA).
• The patient is screen-negative for tuberculosis
• The patient is 18 years of age or above

Exclusion criteria

• The patient has been exposed previously to biological disease modifying anti rheumatic drugs (DMARD) agents.
• Patient has previously participated in this study or the patient has previously been assigned to treatment in a study of CZP or another biological agent used to treat RA.
• Patient has participated in another study within the last 30 days
• Patient has any medical or psychiatric condition that, in the opinion of the physician, can jeopardize or would compromise the patient's ability to adequately participate in the study
• Patient has inadequate literacy to understand and complete the questionnaires.
• Contraindications stated in the SmPC
• Patient is pregnant or breast feeding

Trial design

149 participants in 2 patient groups

Week 12 Disease Activity Score (DAS) Responders

Description:

Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12

Week 12 Disease Activity Score (DAS) Non-Responders

Description:

Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12