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Completed

NCT Number: NCT02679001

A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.

This six months non-interventional, observational, post-marketing, multi-center and local study will evaluate the differences in the use of corticosteroids between RA participants receiving TCZ or a TNF-inhibitor, in participants who have discontinued the use of a TNF-inhibitor as their first biological treatment.

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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

Arvika Sjukhus; Reumatologimottagningen - Medicinmottagningen, Arvika, Sweden

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years of age.
  • With a diagnosis of moderate to severe RA according to the revised (1987) American College of Rheumatology (ACR) criteria or 2010 ACR/ European League Against Rheumatism (EULAR) RA classification criteria.
  • Have had an insufficient response or intolerance to their first TNF-inhibitor (including biosimilars for TNF-inhibitors).
  • The treating physician has made the decision to commence TCZ or TNF-inhibitor treatment. Participants need to have a Disease Activity Score (DAS) 28 assessment at initiation of their second biological treatment.
  • Have been given oral and written information about the study and have no objection to the data concerning him/her being subject to computerized data processing, have given informed consent.

Exclusion criteria

  • Have had more than one TNF-inhibitor prior to the enrolment visit.
  • Have had biological treatment other than TNF-inhibitors.
  • Participants that are continuously treated with per oral corticosteroids for any other indication than RA (at baseline).

Treatment and study plan

TNF inhibitor/TCZ

Drug

Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current SPC/local labeling will be observed.

Other names: COTTON

Primary outcomes

  1. Percentage of participants with a decrease in dose of oral corticosteroids during the study

    Time frame: From baseline to 6 months

Secondary outcomes

  1. Percentage of participants achieving C59CDAI remission (</=2.8)

    Time frame: From baseline to 6 months

  2. Percentage of participants achieving CDAI LDA (</=10)

    Time frame: From baseline to 6 months

  3. Percentage of participants using non-biologic disease-modifying anti-rheumatic drugs (C58MARDs) at treatment initiation and at the end of observation period

    Time frame: Baseline, Month 6

  4. Percentage of participants for whom non-biologic DMARDs was added during observation period

    Time frame: From baseline to 6 months

  5. Percentage of participants with dose change in biological treatment during study

    Time frame: From baseline to 6 months

  6. Percentage of participants with use of oral corticosteroids at treatment initiation and at end of study

    Time frame: From baseline to 6 months

  7. Percentage of participants who started or stopped oral corticosteroid treatment during the study period

    Time frame: From baseline to 6 months

  8. Percentage of participants with increased/decreased/stable dose of corticosteroids from baseline to end of study

    Time frame: From baseline to 6 months

  9. Percentage of participants with change in dose of corticosteroids during study but with same dose at study end as at baseline

    Time frame: From baseline to 6 months

  10. Cumulated doses of oral corticosteroids during study period

    Time frame: From baseline to 6 months

  11. Number of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections

    Time frame: From baseline to 6 months

  12. Cumulated doses of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections

    Time frame: From baseline to 6 months

  13. Cumulated doses of all corticosteroids during study period

    Time frame: From baseline to 6 months

  14. Mean dose of corticosteroids at start and end of study

    Time frame: From baseline to 6 months

  15. Mean change from baseline to end of study of corticosteroids

    Time frame: Baseline, Month 6

  16. Mean change from baseline to end of study in DAS28 (sedimentation rate [SR]) score

    Time frame: Baseline, Month 6

  17. Mean change from baseline to end of study in DAS28 (C-Reactive Protein [CRP]) score

    Time frame: Baseline, Month 6

  18. Mean change from baseline to end of study in crohns disease activity index (CDAI) score

    Time frame: Baseline, Month 6

  19. Mean change from baseline to end of study in swollen 28 joint count

    Time frame: Baseline, Month 6

  20. Mean change from baseline to end of study in tender 28 joint count

    Time frame: Baseline, Month 6

  21. Mean change from baseline to end of study in Physician Global Assessment of disease activity (Visual Analogue Scale [VAS] scale)

    Time frame: Baseline, Month 6

  22. Mean change from baseline to end of study in Patient Global Assessment of disease activity (VAS scale)

    Time frame: Baseline, Month 6

  23. Mean change from baseline to end of study in Health Assessment Questionnaire Disability Index (HAQ-DI)

    Time frame: Baseline, Month 6

  24. Mean change from baseline to end of study in Severity of pain (VAS scale)

    Time frame: Baseline, Month 6

  25. Mean change from baseline to end of study in EULAR response

    Time frame: Baseline, Month 6

  26. Percentage of participants achieving DAS28 remission (less than or equal to [</=] 2.6)

    Time frame: From baseline to 6 months

  27. Percentage of participants achieving DAS 28 Low Disease Activity (LDA) (</=3.2)

    Time frame: From baseline to 6 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A COMPARATIVE OBSERVATIONAL STUDY FOLLOWING THE USE OF CONCOMITANT CORTICOSTEROID TREATMENT IN RA PATIENTS WHO ARE TREATED WITH A TNF INHIBITOR OR TOCILIZUMAB AS THEIR SECOND BIOLOGICAL TREATMENT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 10, 2016
Registry last updated
Jul 26, 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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