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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.

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ClinicalTrials.gov Identifier: NCT02679001
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: TNF inhibitor/TCZ

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official 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
Actual Study Start Date : March 24, 2016
Actual Primary Completion Date : December 7, 2017
Actual Study Completion Date : December 7, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
RA participants treated with a TNF inhibitor or TCZ
Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling will be observed.
Drug: TNF inhibitor/TCZ
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 Name: COTTON




Primary Outcome Measures :
  1. Percentage of participants with a decrease in dose of oral corticosteroids during the study [ Time Frame: From baseline to 6 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with a diagnosis of moderate to severe RA according to the revised (1987) ACR criteria or 2010 ACR/EULAR RA classification criteria who have had an insufficient response or intolerance to their first TNF-inhibitor.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679001


Locations
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Sweden
Arvika Sjukhus; Reumatologimottagningen - Medicinmottagningen
Arvika, Sweden, 671 80
Mälarsjukhuset; Reumatologkliniken
Eskilstuna, Sweden, 631 88
Karolinska University Hospital, Huddinge; Rheumatology
Huddinge, Sweden, SE-141 86
Blekingesjukhuset Karlskrona; Medicin, Rheumatology
Karlskrona, Sweden, 37185
Skånes Universitetssjukhus Malmö; Reumatologkliniken
Malmo, Sweden, 205 02
Capio Citykliniken, Reumatologen
Malmö, Sweden, 212 28
Örebro Uni Hospital; Rheumatology
Oerebro, Sweden, 70185
Kaernsjukhuset; Dept of Medicine
Skoevde, Sweden, 54185
Danderyds Sjukhus Ab; Rheumatology
Stockholm, Sweden, 18288
Lasarettet Trelleborg;Reumatologmottagningen
Trelleborg, Sweden, 231 85
Akademiska sjukhuset, Reumatologkliniken
Uppsala, Sweden, 75185
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02679001    
Other Study ID Numbers: ML29933
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases