Know Cancer

or
forgot password

An Open-label, Observational 12-week Study to Assess Health-related Quality of Life and Patient-reported Outcomes in Patients With Rheumatoid Arthritis Treated With Certolizumab Pegol


N/A
18 Years
N/A
Open (Enrolling)
Both
Rheumatoid Arthritis

Thank you

Trial Information

An Open-label, Observational 12-week Study to Assess Health-related Quality of Life and Patient-reported Outcomes in Patients With Rheumatoid Arthritis Treated With Certolizumab Pegol


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12

Outcome Description:

The HAQ-DI is a measure of function in Rheumatoid Arthritis. There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance). The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability.

Outcome Time Frame:

From Baseline (Week 0) to Week 12

Safety Issue:

No

Principal Investigator

UCB Clinical Trial Call Center

Investigator Role:

Study Director

Investigator Affiliation:

+1 877 822 9493 (UCB)

Authority:

Spain: Spanish Agency of Medicines

Study ID:

RA0053

NCT ID:

NCT01526434

Start Date:

January 2012

Completion Date:

February 2014

Related Keywords:

  • Rheumatoid Arthritis
  • Cimzia
  • Non-interventional
  • Multicenter
  • Postmarketing
  • Local
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location