Health-related Quality of Life and Patient-reported Outcomes in Rheumatoid Arthritis Patients Treated With Certolizumab Pegol

NCT ID: NCT01526434

Last Updated: 2014-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-03-31

Brief Summary

The main objective is to assess Health-Related Quality of Life (HRQoL) according to physical function, as measured by a specific Questionnaire (Health Assessment Questionnaire), in Rheumatoid Arthritis (RA) patients who begin therapy with subcutaneous Anti-Tumour Necrosis Factor alpha (TNFα) Certolizumab Pegol (CZP).

Detailed Description

An open-label, prospective, and post-authorization observational study. This non-interventional study is designed to establish the importance of the measurement of HRQoL data and patient-reported outcomes in clinical practice in patients with RA, and to assess efficacy and safety use of CZP according to the summary of product characteristics.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Certolizumab Pegol treatment

Patients with RA who begin therapy with Certolizumab Pegol (CZP) will be consecutively included in accordance with the selection criteria. The choice of medical treatment is made independently by the physician before evaluating the possible participation of the patient in the protocol.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patient is male or female, aged 18 years or older
• Patient has active Rheumatoid Arthritis according to American College of Rheumatology (ACR) criteria with duration ≥ 3 months
• Patient has DAS28 (ESR) > 4.5 and CRP > 1.0 mg/dl at Baseline
• Patient has failed previous Disease Modifying Anti-Rheumatic Drugs (DMARDs) including Methotrexate treatment
• Patient has initiated treatment with subcutaneous anti-Tumour Necrosis Factor alpha (anti-TNFα) CZP, administered every 2 weeks
• Patient has no other prior anti-TNFα treatment (Naïve Patient) or CZP is administered after failure to the first anti-TNFα treatment (First Switch Patient)
• Patient is considered reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the physician
• Patient has signed and dated a written informed consent form
• The patient's treatment must be within the terms of Summary of Product Characteristics (SmPC)

Exclusion Criteria

• Patient has a known hypersensitivity to the active substance or to any of the excipients
• Patient has active Tuberculosis or other severe infections such as Sepsis or Opportunistic Infections
• Patient has moderate to severe Heart Failure (New York Heart Association (NHYA) classes III/IV)
• Patient has any medical or psychiatric condition that, in the opinion of the physician, could jeopardize or would compromise the patient's ability to participate in this study or to complete the scheduled questionnaires
• Pregnant women or women of childbearing potential who are not using adequate contraception to prevent pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ReSearch Pharmaceutical Services, Inc.

INDUSTRY

Sponsor Role: collaborator

UCB Pharma SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

11

A Coruña, , Spain

15

Barcelona, , Spain

20

Barcelona, , Spain

4

Barcelona, , Spain

7

Barcelona, , Spain

21

Girona, , Spain

9

Granada, , Spain

12

León, , Spain

17

Lleida, , Spain

18

Lleida, , Spain

6

Salamanca, , Spain

10

Seville, , Spain

14

Tarragona, , Spain

16

Tarragona, , Spain

5

Vigo, , Spain

Countries

Spain

Other Identifiers

UCB-CER-2010-01

Identifier Type: -

Identifier Source: secondary_id

RA0053

Identifier Type: -

Identifier Source: org_study_id