Clinical trial NCT01526434: Health-related Quality of Life and Patient-reported Outcomes in Rheumatoid Arthritis Patients Treated With Certolizumab Pegol
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Cimzia
Non-interventional
Multicenter
Postmarketing
Local
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: ReSearch Pharmaceutical Services, Inc.
First posted: 2012-02-03
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with RA who begin therapy with 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 study protocol.

The study will include approximately 105 patients from 20 to 25 sites in Spain.

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.

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

Primary outcomes:
measure: Change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Number of Adverse Drug Reactions (ADRs) during the study (up to 16 weeks)
timeFrame: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
measure: Number of Serious Adverse Drug Reactions (SADRs) during the study (up to 16 weeks)
timeFrame: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
measure: Number of subjects with at least one Adverse Drug Reaction (ADR) during the study (up to 16 weeks)
timeFrame: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
Secondary outcomes:
measure: Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Change from Baseline in Patient's Assessment of Arthritis Pain- Visual Analog Scale (VAS) at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Change from Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Change from Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Change from Baseline in the Rheumatoid Factor (RF) at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Change from Baseline in Serum C-reactive Protein (CRP) level at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Change from Baseline in the C3 level at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Change from Baseline in the C4 level at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Predictive value of Baseline global ultrasound index in relation to DAS28 at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Predictive value of Week 6 global ultrasound index in relation to DAS28 at Week 12
timeFrame: From Week 6 to Week 12
measure: Predictive value of Baseline laboratory data ESR in relation to DAS28 at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Predictive value of Week 6 laboratory data ESR in relation to DAS28 at Week 12
timeFrame: From Week 6 to Week 12
measure: Predictive value of Baseline laboratory data CRP in relation to DAS28 at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Predictive value of Week 6 laboratory data CRP in relation to DAS28 at Week 12
timeFrame: From Week 6 to Week 12
measure: Predictive value of Baseline laboratory data RF in relation to DAS28 at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Predictive value of Week 6 laboratory data RF in relation to DAS28 at Week 12
timeFrame: From Week 6 to Week 12
measure: Predictive value of Baseline Reduced models of ultrasound joint count in relation to DAS28 at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Predictive value of Week 6 Reduced models of ultrasound joint count in relation to DAS28 at Week 12
timeFrame: From Week 6 to Week 12
measure: Predictive value of Baseline Reduced models of ultrasound index in relation to DAS28 at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Predictive value of Week 6 Reduced models of ultrasound index in relation to DAS28 at Week 12
timeFrame: From Week 6 to Week 12
measure: Change from Baseline in global ultrasound index at Week 6
timeFrame: From Baseline (Week 0) to Week 6
measure: Change from Baseline in global ultrasound index at Week 12
timeFrame: From Baseline (Week 0) to Week 12
measure: Number of injection site reactions during the study (up to 16 weeks)
timeFrame: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: 11
city: Barcelona
country: Spain
facility: 15
city: Barcelona
country: Spain
facility: 20
city: Barcelona
country: Spain
facility: 4
city: Barcelona
country: Spain
facility: 7
city: Girona
country: Spain
facility: 21
city: Granada
country: Spain
facility: 9
city: Leon
country: Spain
facility: 12
city: Lerida
country: Spain
facility: 18
city: Lérida
country: Spain
facility: 17
city: Salamanca
country: Spain
facility: 6
city: Sevilla
country: Spain
facility: 10
city: Tarragona
country: Spain
facility: 14
city: Tarragona
country: Spain
facility: 16
city: Vigo
country: Spain
facility: 5
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: