Rheumatoid ArthritisSONAR-12NCT01526434
Health-related Quality of Life and Patient-reported Outcomes in Rheumatoid Arthritis Patients Treated With Certolizumab Pegol
An observational study of Rheumatoid Arthritis, run by UCB Pharma SA at 15 sites in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 81 participants
- Where
- 15 sitesSpain
- Study dates
- Jan 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
11
A Coruña
15
Barcelona
20
Barcelona
4
Barcelona
7
Barcelona
21
Girona
9
Granada
12
León
17
Lleida
18
Lleida
6
Salamanca
10
Seville
14
Tarragona
16
Tarragona
5
Vigo
About this study
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
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).
Read the 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
- Keywords
- Cimzia, Non-interventional, Multicenter, Postmarketing, Local
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline (Week 0) to Week 12
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.
Measured: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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.
Measured: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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.
Measured: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
Secondary outcomes (24)
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).
Measured: From Baseline (Week 0) to Week 12
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).
Measured: From Baseline (Week 0) to Week 12
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).
Measured: From Baseline (Week 0) to Week 12
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.
Measured: From Baseline (Week 0) to Week 12
Change from Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12
ESR is an inflammatory parameter measured in mm/h.
Measured: From Baseline (Week 0) to Week 12
Change from Baseline in the Rheumatoid Factor (RF) at Week 12
RF is an inflammatory parameter measured in International Units (IU)/ml.
Measured: From Baseline (Week 0) to Week 12
Change from Baseline in Serum C-reactive Protein (CRP) level at Week 12
CRP is an inflammatory parameter measured in mg/l.
Measured: From Baseline (Week 0) to Week 12
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.
Measured: From Baseline (Week 0) to Week 12
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.
Measured: From Baseline (Week 0) to Week 12
Predictive value of Baseline global ultrasound index in relation to DAS28 at Week 12
Measured: From Baseline (Week 0) to Week 12
Predictive value of Week 6 global ultrasound index in relation to DAS28 at Week 12
Measured: From Week 6 to Week 12
Predictive value of Baseline laboratory data ESR in relation to DAS28 at Week 12
Measured: From Baseline (Week 0) to Week 12
Predictive value of Week 6 laboratory data ESR in relation to DAS28 at Week 12
Measured: From Week 6 to Week 12
Predictive value of Baseline laboratory data CRP in relation to DAS28 at Week 12
Measured: From Baseline (Week 0) to Week 12
Predictive value of Week 6 laboratory data CRP in relation to DAS28 at Week 12
Measured: From Week 6 to Week 12
Predictive value of Baseline laboratory data RF in relation to DAS28 at Week 12
Measured: From Baseline (Week 0) to Week 12
Predictive value of Week 6 laboratory data RF in relation to DAS28 at Week 12
Measured: From Week 6 to Week 12
Predictive value of Baseline Reduced models of ultrasound joint count in relation to DAS28 at Week 12
Measured: From Baseline (Week 0) to Week 12
Predictive value of Week 6 Reduced models of ultrasound joint count in relation to DAS28 at Week 12
Measured: From Week 6 to Week 12
Predictive value of Baseline Reduced models of ultrasound index in relation to DAS28 at Week 12
Measured: From Baseline (Week 0) to Week 12
Predictive value of Week 6 Reduced models of ultrasound index in relation to DAS28 at Week 12
Measured: From Week 6 to Week 12
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.
Measured: From Baseline (Week 0) to Week 6
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.
Measured: From Baseline (Week 0) to Week 12
Number of injection site reactions during the study (up to 16 weeks)
Injection site reactions include: erythema, itching, haematoma, pain, swelling or bruising.
Measured: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ReSearch Pharmaceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526434
- Sponsor's protocol ID
- RA0053
- Other IDs
- UCB-CER-2010-01
- Acronym
- SONAR-12
- Status last verified
- Mar 2014
- First submitted
- 1 Feb 2012
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01526434
- Acronym / sponsor ID
- SONAR-12 / RA0053
- Conditions
- Rheumatoid Arthritis
- Keywords
- Cimzia, Non-interventional, Multicenter, Postmarketing, Local
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- UCB Pharma SAIndustry (pharma, biotech, devices)
- Collaborators
- ReSearch Pharmaceutical Services, Inc.
- Study start
- Jan 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Time frame: From Baseline (Week 0) to 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.
Number of Adverse Drug Reactions (ADRs) during the study (up to 16 weeks)
Time frame: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected.
Number of Serious Adverse Drug Reactions (SADRs) during the study (up to 16 weeks)
Time frame: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
A SADR is a serious Adverse Event for which a causal relationship between the product and the occurrence is suspected.
Number of subjects with at least one Adverse Drug Reaction (ADR) during the study (up to 16 weeks)
Time frame: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected.
24 secondary outcomes
Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) at Week 12
Time frame: From Baseline (Week 0) to Week 12
Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) at Week 12
Time frame: From Baseline (Week 0) to Week 12
Change from Baseline in Patient's Assessment of Arthritis Pain- Visual Analog Scale (VAS) at Week 12
Time frame: From Baseline (Week 0) to Week 12
Change from Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) at Week 12
Time frame: From Baseline (Week 0) to Week 12
Change from Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12
Time frame: From Baseline (Week 0) to Week 12
Change from Baseline in the Rheumatoid Factor (RF) at Week 12
Time frame: From Baseline (Week 0) to Week 12
Change from Baseline in Serum C-reactive Protein (CRP) level at Week 12
Time frame: From Baseline (Week 0) to Week 12
Change from Baseline in the C3 level at Week 12
Time frame: From Baseline (Week 0) to Week 12
Change from Baseline in the C4 level at Week 12
Time frame: From Baseline (Week 0) to Week 12
Predictive value of Baseline global ultrasound index in relation to DAS28 at Week 12
Time frame: From Baseline (Week 0) to Week 12
Predictive value of Week 6 global ultrasound index in relation to DAS28 at Week 12
Time frame: From Week 6 to Week 12
Predictive value of Baseline laboratory data ESR in relation to DAS28 at Week 12
Time frame: From Baseline (Week 0) to Week 12
Predictive value of Week 6 laboratory data ESR in relation to DAS28 at Week 12
Time frame: From Week 6 to Week 12
Predictive value of Baseline laboratory data CRP in relation to DAS28 at Week 12
Time frame: From Baseline (Week 0) to Week 12
Predictive value of Week 6 laboratory data CRP in relation to DAS28 at Week 12
Time frame: From Week 6 to Week 12
Predictive value of Baseline laboratory data RF in relation to DAS28 at Week 12
Time frame: From Baseline (Week 0) to Week 12
Predictive value of Week 6 laboratory data RF in relation to DAS28 at Week 12
Time frame: From Week 6 to Week 12
Predictive value of Baseline Reduced models of ultrasound joint count in relation to DAS28 at Week 12
Time frame: From Baseline (Week 0) to Week 12
Predictive value of Week 6 Reduced models of ultrasound joint count in relation to DAS28 at Week 12
Time frame: From Week 6 to Week 12
Predictive value of Baseline Reduced models of ultrasound index in relation to DAS28 at Week 12
Time frame: From Baseline (Week 0) to Week 12
Predictive value of Week 6 Reduced models of ultrasound index in relation to DAS28 at Week 12
Time frame: From Week 6 to Week 12
Change from Baseline in global ultrasound index at Week 6
Time frame: From Baseline (Week 0) to Week 6
Change from Baseline in global ultrasound index at Week 12
Time frame: From Baseline (Week 0) to Week 12
Number of injection site reactions during the study (up to 16 weeks)
Time frame: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by UCB Pharma SA at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (time frame: From Baseline (Week 0) to Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2014.