Clinical trial · Observational
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.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TNF inhibitor/TCZ | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- RA participants treated with a TNF inhibitor or TCZ
- description
- 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.
- interventionNames
- Drug: TNF inhibitor/TCZ
Primary outcomes (1)
- measure
- Percentage of participants with a decrease in dose of oral corticosteroids during the study
- timeFrame
- From baseline to 6 months
Secondary outcomes (27)
- measure
- Percentage of participants achieving C59CDAI remission (</=2.8)
- timeFrame
- From baseline to 6 months
- measure
- Percentage of participants achieving CDAI LDA (</=10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available