A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)

Hoffmann-La Roche50 enrolled

Overview

This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs. Data will be collected from each eligible participant initiating tocilizumab treatment over 6 months.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

TocilizumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Moderate to severe active RA (European League Against Rheumatism \[EULAR\] criteria) * Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists * Initiating treatment with tocilizumab according to SPC Exclusion Criteria: * Rheumatic autoimmune disease other than RA * Prior history or current inflammatory joint disease other than RA * Previous treatment with any biological drug used in the treatment of RA * Previous treatment with tocilizumab * Any contraindication to treatment with tocilizumab * Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment * Pregnant women or nursing (breastfeeding) mothers

Locations (1)

Unnamed facility

Podgorica, Montenegro

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

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.

Time frame: Baseline up to Week 24

Secondary Outcomes

Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria

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.

Time frame: Baseline, Week 24

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

Data from ClinicalTrials.gov

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