A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)
|ClinicalTrials.gov Identifier: NCT01617005|
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : December 1, 2016
Last Update Posted : December 1, 2016
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis||Drug: Tocilizumab|
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD|
|Study Start Date :||May 2012|
|Primary Completion Date :||September 2014|
|Study Completion Date :||September 2014|
Tocilizumab in Moderate to Severe Active RA
Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), will be observed. The choice of therapy will be based exclusively on the medical decision of the treating physician before study enrollment. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
Participants will receive tocilizumab treatment according to effective official SPC. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
- Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline up to Week 24 ]An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs.
- Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria [ Time Frame: Baseline, Week 24 ]EULAR response was based on 28-joint disease activity score (DAS28). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score). Good responders had a CFB greater than (>) 1.2 with a DAS28 score less than or equal to (<=) 3.2; moderate responders had a CFB >1.2 with a DAS28 score >3.2 to <= 5.1 or a change from baseline >0.6 to <= 1.2 with a DAS28 score <= 5.1; non-responders had a CFB <=0.6 or CFB >0.6 to <=1.2 with DAS28 >5.1. Number of participants who achieved EULAR good response and EULAR moderate response were reported.
- Number of Participants Who Discontinued Treatment Due to Lack of Efficacy [ Time Frame: Baseline up to Week 24 ]
- Time to Discontinuation Due to Lack of Efficacy [ Time Frame: Baseline up to Week 24 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617005
|Podgorica, Montenegro, 81000|
|Study Director:||Clinical Trials||Hoffmann-La Roche|