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Completed

NCT Number: NCT01526434

Health-related Quality of Life and Patient-reported Outcomes in Rheumatoid Arthritis Patients 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).

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

11, A Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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

    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).

  2. 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

    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).

  3. 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

    VAS ranges from 0 (no pain) to 100 (worst pain).

  4. 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

    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.

  5. Change from Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12

    Time frame: From Baseline (Week 0) to Week 12

    ESR is an inflammatory parameter measured in mm/h.

  6. Change from Baseline in the Rheumatoid Factor (RF) at Week 12

    Time frame: From Baseline (Week 0) to Week 12

    RF is an inflammatory parameter measured in International Units (IU)/ml.

  7. Change from Baseline in Serum C-reactive Protein (CRP) level at Week 12

    Time frame: From Baseline (Week 0) to Week 12

    CRP is an inflammatory parameter measured in mg/l.

  8. Change from Baseline in the C3 level at Week 12

    Time frame: From Baseline (Week 0) to 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.

  9. Change from Baseline in the C4 level at Week 12

    Time frame: From Baseline (Week 0) to 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.

  10. Predictive value of Baseline global ultrasound index in relation to DAS28 at Week 12

    Time frame: From Baseline (Week 0) to Week 12

  11. Predictive value of Week 6 global ultrasound index in relation to DAS28 at Week 12

    Time frame: From Week 6 to Week 12

  12. Predictive value of Baseline laboratory data ESR in relation to DAS28 at Week 12

    Time frame: From Baseline (Week 0) to Week 12

  13. Predictive value of Week 6 laboratory data ESR in relation to DAS28 at Week 12

    Time frame: From Week 6 to Week 12

  14. Predictive value of Baseline laboratory data CRP in relation to DAS28 at Week 12

    Time frame: From Baseline (Week 0) to Week 12

  15. Predictive value of Week 6 laboratory data CRP in relation to DAS28 at Week 12

    Time frame: From Week 6 to Week 12

  16. Predictive value of Baseline laboratory data RF in relation to DAS28 at Week 12

    Time frame: From Baseline (Week 0) to Week 12

  17. Predictive value of Week 6 laboratory data RF in relation to DAS28 at Week 12

    Time frame: From Week 6 to Week 12

  18. 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

  19. 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

  20. 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

  21. 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

  22. Change from Baseline in global ultrasound index at Week 6

    Time frame: From Baseline (Week 0) to 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.

  23. Change from Baseline in global ultrasound index at Week 12

    Time frame: From Baseline (Week 0) to 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.

  24. 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)

    Injection site reactions include: erythema, itching, haematoma, pain, swelling or bruising.

Sponsors and collaborators

Lead sponsor

UCB Pharma SA

Industry

Collaborators

  • ReSearch Pharmaceutical Services, Inc.

Registry information

Official study 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

Acronym: SONAR-12

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2012
Registry last updated
Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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