Rheumatoid Arthritis Clinical Trial
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
NCT number | NCT02679001 |
Other study ID # | ML29933 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 24, 2016 |
Est. completion date | December 7, 2017 |
Verified date | July 2018 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 7, 2017 |
Est. primary completion date | December 7, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Sweden | Arvika Sjukhus; Reumatologimottagningen - Medicinmottagningen | Arvika | |
Sweden | Mälarsjukhuset; Reumatologkliniken | Eskilstuna | |
Sweden | Karolinska University Hospital, Huddinge; Rheumatology | Huddinge | |
Sweden | Blekingesjukhuset Karlskrona; Medicin, Rheumatology | Karlskrona | |
Sweden | Skånes Universitetssjukhus Malmö; Reumatologkliniken | Malmo | |
Sweden | Capio Citykliniken, Reumatologen | Malmö | |
Sweden | Örebro Uni Hospital; Rheumatology | Oerebro | |
Sweden | Kaernsjukhuset; Dept of Medicine | Skoevde | |
Sweden | Danderyds Sjukhus Ab; Rheumatology | Stockholm | |
Sweden | Lasarettet Trelleborg;Reumatologmottagningen | Trelleborg | |
Sweden | Akademiska sjukhuset, Reumatologkliniken | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of participants with a decrease in dose of oral corticosteroids during the study | From baseline to 6 months | ||
Secondary | Percentage of participants achieving C59CDAI remission (</=2.8) | From baseline to 6 months | ||
Secondary | Percentage of participants achieving CDAI LDA (</=10) | From baseline to 6 months | ||
Secondary | Percentage of participants using non-biologic disease-modifying anti-rheumatic drugs (C58MARDs) at treatment initiation and at the end of observation period | Baseline, Month 6 | ||
Secondary | Percentage of participants for whom non-biologic DMARDs was added during observation period | From baseline to 6 months | ||
Secondary | Percentage of participants with dose change in biological treatment during study | From baseline to 6 months | ||
Secondary | Percentage of participants with use of oral corticosteroids at treatment initiation and at end of study | From baseline to 6 months | ||
Secondary | Percentage of participants who started or stopped oral corticosteroid treatment during the study period | From baseline to 6 months | ||
Secondary | Percentage of participants with increased/decreased/stable dose of corticosteroids from baseline to end of study | From baseline to 6 months | ||
Secondary | Percentage of participants with change in dose of corticosteroids during study but with same dose at study end as at baseline | From baseline to 6 months | ||
Secondary | Cumulated doses of oral corticosteroids during study period | From baseline to 6 months | ||
Secondary | Number of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections | From baseline to 6 months | ||
Secondary | Cumulated doses of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections | From baseline to 6 months | ||
Secondary | Cumulated doses of all corticosteroids during study period | From baseline to 6 months | ||
Secondary | Mean dose of corticosteroids at start and end of study | From baseline to 6 months | ||
Secondary | Mean change from baseline to end of study of corticosteroids | Baseline, Month 6 | ||
Secondary | Mean change from baseline to end of study in DAS28 (sedimentation rate [SR]) score | Baseline, Month 6 | ||
Secondary | Mean change from baseline to end of study in DAS28 (C-Reactive Protein [CRP]) score | Baseline, Month 6 | ||
Secondary | Mean change from baseline to end of study in crohns disease activity index (CDAI) score | Baseline, Month 6 | ||
Secondary | Mean change from baseline to end of study in swollen 28 joint count | Baseline, Month 6 | ||
Secondary | Mean change from baseline to end of study in tender 28 joint count | Baseline, Month 6 | ||
Secondary | Mean change from baseline to end of study in Physician Global Assessment of disease activity (Visual Analogue Scale [VAS] scale) | Baseline, Month 6 | ||
Secondary | Mean change from baseline to end of study in Patient Global Assessment of disease activity (VAS scale) | Baseline, Month 6 | ||
Secondary | Mean change from baseline to end of study in Health Assessment Questionnaire Disability Index (HAQ-DI) | Baseline, Month 6 | ||
Secondary | Mean change from baseline to end of study in Severity of pain (VAS scale) | Baseline, Month 6 | ||
Secondary | Mean change from baseline to end of study in EULAR response | Baseline, Month 6 | ||
Secondary | Percentage of participants achieving DAS28 remission (less than or equal to [</=] 2.6) | From baseline to 6 months | ||
Secondary | Percentage of participants achieving DAS 28 Low Disease Activity (LDA) (</=3.2) | From baseline to 6 months |
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