Clinical trial · Observational
Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy
A Study to Observe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti TNF Therapy.
NCT01362062CI-TRIAL-00028908completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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 observational study will evaluate the safety, tolerability and efficacy of tocilizumab in participants with moderate to severe RA who have an inadequate response to current non-biologic DMARD and/or anti-TNF therapy. Data will be collected from each participant during tocilizumab therapy and on follow-up for a total of 12 months.
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 |
|---|---|---|---|
| Tocilizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- RA Cohort
- description
- Participants with active RA who had an inadequate clinical response to current non-biologic disease modifying anti-rheumatoid drug (DMARD) and/or anti-tumor necrosis factor (anti-TNF) therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information will be observed for a total duration of 12 months.
- interventionNames
- Drug: Tocilizumab
Primary outcomes (1)
- measure
- Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs)
- timeFrame
- Up to 12 months
- description
- An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal product. An AE is considered as an SAE if it fulfills one of the following criteria: a) fatal or life-threatening, b) requires in-patient hospitalization or prolongation of existing hospitalization, c) results in a persistent or significant disability, d) results in a congenital abnormality/birth defect, e) is medically significant. AEs included serious as well as non-serious AEs.
Secondary outcomes (13)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Moderate to severe active RA with an inadequate response to existing therapies (DMARDs and/or anti-TNFs) * Considered eligible for tocilizumab therapy by the treating physician as per routine clinical practice Exclusion Criteria: * Pregnant or breastfeeding females * Immunization with live/attenuated vaccine within 4 weeks prior to baseline * Participants with clinically significant raised liver enzyme, abnormal lipid profile, platelet count, hemoglobin, white blood cell and neutrophil count * History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies * Participants with active tuberculosis (TB). Participants with latent TB should be treated with standard anti-mycobacterial therapy before initiating tocilizumab and have a negative chest x ray for active TB at enrolment * History of diverticulitis, chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations then the benefit risk ratio should be considered by treating physician * Know active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infection * History of or currently active primary or secondary immunodeficiency or known human immunodeficiency virus (HIV) positive status * Any other condition which puts the participant to undue risk for tocilizumab therapy as per local prescribing information or Investigator's judgement
References
Publications (0)
Data not yet available
No reference posted for this study.