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Completed

NCT Number: NCT02552940

An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical Practice

This observational trial will evaluate the effectiveness, the consistency of evaluation scores, quality of life, safety and tolerability of TCZ administered subcutaneously (SC) in participants with RA in daily clinical practice.

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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

ASZ Aalst, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants naive to TCZ or who have received TCZ SC treatment within 8 weeks prior to the enrolment visit can be included
  • Participants in whom the treating physician has made the decision to commence TCZ SC in accordance with the label and reimbursement criteria

Exclusion criteria

  • Participants who have received TCZ >8 weeks prior to the enrolment visit
  • Participants who have previously received TCZ SC
  • Participants who have received treatment with any investigational agent within 4 weeks before starting treatment with TCZ SC

Treatment and study plan

Tocilizumab

Drug

Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.

Other names: RoACTEMRA

Primary outcomes

  1. Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl)

    Time frame: Up to Week 24

Secondary outcomes

  1. Correlation Coefficient Between CDAI and simplified disease activity index (SDAI) and Between SDAI and DAS28-ESR

    Time frame: Up to Week 24

  2. Percentage of participants to achieve low disease activity (LDA) using DAS28 (less than or equal to [<=] 3.2), CDAl (<=10.0) and SDAI (<=11 .0)

    Time frame: Up to Week 24

  3. Time to achieve low disease activity (LDA) using DAS28 (<= 3.2), CDAl (<=10.0) and SDAI (<=11 .0)

    Time frame: Up to week 24

  4. Percentage of participants to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)

    Time frame: Up to Week 24

  5. Time to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)

    Time frame: Up to Week 24

  6. Percentage of participants to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)

    Time frame: Up to Week 24

  7. Time to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)

    Time frame: Up to Week 24

  8. Percentage of participants to achieve a major and minor improvement in CDAl (more than or equal to [>=]13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively)

    Time frame: Up to Week 24

  9. Time to achieve a major and minor improvement in CDAl (>=13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively)

    Time frame: Up to Week 24

  10. Change from baseline in total tender joint count (TJC)

    Time frame: Up to Week 24

  11. Change from baseline in total swollen joint count (SJC)

    Time frame: Up to Week 24

  12. Percentage of participants having TJC <=1

    Time frame: Up to Week 24

  13. Percentage of participants having SJC <=1

    Time frame: Up to Week 24

  14. Patient Global Assessment of disease activity visual analogue scale (VAS) score

    Time frame: Up to Week 24

  15. Physician Global Assessment of disease activity VAS score

    Time frame: Up to Week 24

  16. Percentage of participants having CRP <=1mg/dl

    Time frame: Up to Week 24

  17. Health Assessment Questionnaire Disability Index (HAQ-DI)

    Time frame: Up to Week 24

  18. EQ-5D-5L Health Questionnaire (EuroQoL)

    Time frame: Up to Week 24

  19. Morisky Medication-Taking Adherence Scale (MMAS)

    Time frame: Up to Week 24

  20. Percentage of participants using TCZ in monotherapy

    Time frame: At baseline

  21. Percentage of participants using TCZ in combination with disease-modifying antirheumatic drug's (DMARD's)

    Time frame: At baseline

  22. Percentage of participants presenting a high inflammation (DAS28-ESR >5.1)

    Time frame: At baseline

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • nv Roche sa

Registry information

Official study title

A PROSPECTIVE, NON-INTERVENTIONAL STUDY TO EVALUATE THE CLINICAL EFFECTIVENESS, THE CONSISTENCY OF EVALUATION SCORES, QUALITY OF LIFE, SAFETY AND TOLERABILITY OF TOCILIZUMAB SUBCUTANEOUS IN PATIENTS WITH RHEUMATOID ARTHRITIS IN DAILY CLINICAL PRACTICE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 17, 2015
Registry last updated
May 11, 2018

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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