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

Rheumatoid Arthritis Clinical Trial

— SONAR-12  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526434
• Other study ID #: RA0053
• Secondary ID: UCB-CER-2010-01
• Status: Completed
• Phase: N/A
• First received: February 1, 2012
• Last updated: March 18, 2014
• Start date: January 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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-TNFa) CZP, administered every 2 weeks

• Patient has no other prior anti-TNFa treatment (Naïve Patient) or CZP is administered after failure to the first anti-TNFa 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Spain	11	A Coruña
Spain	15	Barcelona
Spain	20	Barcelona
Spain	4	Barcelona
Spain	7	Barcelona
Spain	21	Girona
Spain	9	Granada
Spain	12	Leon
Spain	18	Lerida
Spain	17	Lérida
Spain	6	Salamanca
Spain	10	Sevilla
Spain	14	Tarragona
Spain	16	Tarragona
Spain	5	Vigo

Sponsors (2)

Lead Sponsor	Collaborator
UCB Pharma SA	ReSearch Pharmaceutical Services, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12	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.	From Baseline (Week 0) to Week 12	No
Primary	Number of Adverse Drug Reactions (ADRs) during the study (up to 16 weeks)	An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected.	From Baseline (Week 0) to the end of the Follow-up Period (Week 16)	No
Primary	Number of Serious Adverse Drug Reactions (SADRs) during the study (up to 16 weeks)	A SADR is a serious Adverse Event for which a causal relationship between the product and the occurrence is suspected.	From Baseline (Week 0) to the end of the Follow-up Period (Week 16)	No
Primary	Number of subjects with at least one Adverse Drug Reaction (ADR) during the study (up to 16 weeks)	An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected.	From Baseline (Week 0) to the end of the Follow-up Period (Week 16)	No
Secondary	Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) at Week 12	The SF-36 measures the Health Related Quality of Life (HRQoL). It is a 36-item survey that measures eight domains of health. Four of these domains belong to physical health and four domains to mental health. Domain scores are generated from the SF-36. In addition, two summary scores can also be derived from the SF-36: The Physical Component Summary (PCS) and the Mental Component Summary (MCS).	From Baseline (Week 0) to Week 12	No
Secondary	Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) at Week 12	The SF-36 measures the Health Related Quality of Life (HRQoL). It is a 36-item survey that measures eight domains of health. Four of these domains belong to physical health and four domains to mental health. Domain scores are generated from the SF-36. In addition, two summary scores can also be derived from the SF-36: The Physical Component Summary (PCS) and the Mental Component Summary (MCS).	From Baseline (Week 0) to Week 12	No
Secondary	Change from Baseline in Patient's Assessment of Arthritis Pain- Visual Analog Scale (VAS) at Week 12	VAS ranges from 0 (no pain) to 100 (worst pain).	From Baseline (Week 0) to Week 12	No
Secondary	Change from Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) at Week 12	The DAS28 is used for assessing disease activity in RA. The number of swollen and tender joints will be assessed using 28-joint counts (tender 28 and swollen 28). The ESR is measured in mm/h. In addition the Patient's General Health (GH) is obtained and recorded on a Visual Analog Scale (VAS) of 100 mm. Using this data, the DAS28 [ESR] can be calculated.	From Baseline (Week 0) to Week 12	No
Secondary	Change from Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12	ESR is an inflammatory parameter measured in mm/h.	From Baseline (Week 0) to Week 12	No
Secondary	Change from Baseline in the Rheumatoid Factor (RF) at Week 12	RF is an inflammatory parameter measured in International Units (IU)/ml.	From Baseline (Week 0) to Week 12	No
Secondary	Change from Baseline in Serum C-reactive Protein (CRP) level at Week 12	CRP is an inflammatory parameter measured in mg/l.	From Baseline (Week 0) to Week 12	No
Secondary	Change from Baseline in the C3 level at Week 12	C3 is an inflammatory parameter. This measurement includes only subjects for which C3 data are available in the medical history of the subject.	From Baseline (Week 0) to Week 12	No
Secondary	Change from Baseline in the C4 level at Week 12	C4 is an inflammatory parameter. This measurement includes only subjects for which C4 data are available in the medical history of the subject.	From Baseline (Week 0) to Week 12	No
Secondary	Predictive value of Baseline global ultrasound index in relation to DAS28 at Week 12		From Baseline (Week 0) to Week 12	No
Secondary	Predictive value of Week 6 global ultrasound index in relation to DAS28 at Week 12		From Week 6 to Week 12	No
Secondary	Predictive value of Baseline laboratory data ESR in relation to DAS28 at Week 12		From Baseline (Week 0) to Week 12	No
Secondary	Predictive value of Week 6 laboratory data ESR in relation to DAS28 at Week 12		From Week 6 to Week 12	No
Secondary	Predictive value of Baseline laboratory data CRP in relation to DAS28 at Week 12		From Baseline (Week 0) to Week 12	No
Secondary	Predictive value of Week 6 laboratory data CRP in relation to DAS28 at Week 12		From Week 6 to Week 12	No
Secondary	Predictive value of Baseline laboratory data RF in relation to DAS28 at Week 12		From Baseline (Week 0) to Week 12	No
Secondary	Predictive value of Week 6 laboratory data RF in relation to DAS28 at Week 12		From Week 6 to Week 12	No
Secondary	Predictive value of Baseline Reduced models of ultrasound joint count in relation to DAS28 at Week 12		From Baseline (Week 0) to Week 12	No
Secondary	Predictive value of Week 6 Reduced models of ultrasound joint count in relation to DAS28 at Week 12		From Week 6 to Week 12	No
Secondary	Predictive value of Baseline Reduced models of ultrasound index in relation to DAS28 at Week 12		From Baseline (Week 0) to Week 12	No
Secondary	Predictive value of Week 6 Reduced models of ultrasound index in relation to DAS28 at Week 12		From Week 6 to Week 12	No
Secondary	Change from Baseline in global ultrasound index at Week 6	Ultrasound assessment by global ultrasound index consists of 24-joint detection and grading (from 0 to 3) of gray-scale synovitis and power doppler synovial signal.	From Baseline (Week 0) to Week 6	No
Secondary	Change from Baseline in global ultrasound index at Week 12	Ultrasound assessment by global ultrasound index consists of 24-joint detection and grading (from 0 to 3) of gray-scale synovitis and power doppler synovial signal.	From Baseline (Week 0) to Week 12	No
Secondary	Number of injection site reactions during the study (up to 16 weeks)	Injection site reactions include: erythema, itching, haematoma, pain, swelling or bruising.	From Baseline (Week 0) to the end of the Follow-up Period (Week 16)	No