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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.

Tocilizumab

Clinical Trials

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.

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.

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.

DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, erythrocyte sedimentation rate (ESR) (in millimeters \[mm\]/hour), and the participant's global assessment of disease activity (100 mm visual analog scale \[VAS\]: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*square root (√) of TJC + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A reduction of at least 1.2 units of DAS28 score from previous visit is considered as clinically meaningful improvement.

DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A reduction of at least 1.2 units of DAS28 score from previous visit is considered as clinically meaningful improvement. Time taken to achieve clinically meaningful improvement in DAS28 was reported.

DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low Disease Activity is defined as DAS28 value of \<3.2 Units at the time of assessment.

DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low disease activity is defined as decrease in DAS28 to a value \<3.2 Units at the time of assessment. Time taken to achieve low disease activity was reported.

DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). Remission is defined as DAS28 value of \<2.6 units at the time of assessment.

DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). Remission is defined as DAS28 value of \<2.6 units at the time of assessment. Time taken to achieve remission is reported.

ACR20/ACR50/ACR70/ACR 90 response: greater than or equal to (≥) 20%/50%/70%/90% improvement in tender and swollen joint counts and 20%/50%/70%/90% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) Participant assessment of disease activity, 3) Participant assessment of pain (VAS), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) ESR at each visit.

The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, and is described as "maximum disease activity" (maximum arthritis disease activity). A negative change from baseline indicated improvement.

The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, and is described as "maximum disease activity" (maximum arthritis disease activity).

The participant assessed their pain on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm, and is described as "unbearable pain". A negative change indicated improvement.

HAQ-DI is a self-completed patient questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The HAQ-DI is the sum of the scores from all domains and ranged from 0 (best) to 24 (worst). A negative change from baseline indicated improvement.

Hoffmann-La Roche

Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.

RA Cohort (Prospective + Retrospective)

Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.

RA Cohort (Prospective)

Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed retrospectively for a total duration of 12 months.

RA Cohort (Retrospective)

Total

Age, Continuous

Sex: Female, Male

All enrolled participants who were considered evaluable for analysis.

Medical Communications

SAEs

Safety analysis population: Included all participants who received at least 1 dose of study drug.

Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs)

Visit 3 (n=38)

Visit 4 (n=37)

Visit 5 (n=37)

Visit 6 (n=36)

Visit 7 (n=39)

Visit 8 (n=21)

Visit 9 (n=20)

Visit 10 (n=18)

Visit 11 (n=23)

Visit 12 (n=20)

Visit 13 (n=17)

Overall (n=43)

Efficacy analysis population included participants who were observed prospectively in this study. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.

Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit

Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.

Time Required to Achieve Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)

Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.

Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit

Time Required to Achieve Low Disease Activity (DAS28 <3.2 Units)

Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit

Time Taken to Achieve Remission (DAS28 <2.6 Units)

Visit 3: ACR 20 response (n=29)

Visit 3: ACR 50 response (n=29)

Visit 3: ACR 70 response (n=29)

Visit 3: ACR 90 response (n=29)

Visit 4: ACR 20 response (n=33)

Visit 4: ACR 50 response (n=33)

Visit 4: ACR 70 response (n=33)

Visit 4: ACR 90 response (n=33)

Visit 5: ACR 20 response (n=28)

Visit 5: ACR 50 response (n=28)

Visit 5: ACR 70 response (n=28)

Visit 5: ACR 90 response (n=28)

Visit 6: ACR 20 response (n=31)

Visit 6: ACR 50 response (n=31)

Visit 6: ACR 70 response (n=31)

Visit 6: ACR 90 response (n=31)

Visit 7: ACR 20 response (n=30)

Visit 7: ACR 50 response (n=30)

Visit 7: ACR 70 response (n=30)

Visit 7: ACR 90 response (n=30)

Visit 8: ACR 20 response (n=17)

Visit 8: ACR 50 response (n=17)

Visit 8: ACR 70 response (n=17)

Visit 8: ACR 90 response (n=17)

Visit 9: ACR 20 response (n=16)

Visit 9: ACR 50 response (n=16)

Visit 9: ACR 70 response (n=16)

Visit 9: ACR 90 response (n=16)

Visit 10: ACR 20 response (n=12)

Visit 10: ACR 50 response (n=12)

Visit 10: ACR 70 response (n=12)

Visit 10: ACR 90 response (n=12)

Visit 11: ACR 20 response (n=17)

Visit 11: ACR 50 response (n=17)

Visit 11: ACR 70 response (n=17)

Visit 11: ACR 90 response (n=17)

Visit 12: ACR 20 response (n=15)

Visit 12: ACR 50 response (n=15)

Visit 12: ACR 70 response (n=15)

Visit 12: ACR 90 response (n=15)

Visit 13: ACR 20 response (n=11)

Visit 13: ACR 50 response (n=11)

Visit 13: ACR 70 response (n=11)

Visit 13: ACR 90 response (n=11)

Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit

Statistical analysis for CFB at Visit 10.

Statistical analysis for CFB at Visit 11.

Statistical analysis for CFB at Visit 12.

Statistical analysis for CFB at Visit 13.

CFB at Visit 3

CFB at Visit 4

CFB at Visit 5

CFB at Visit 6

CFB at Visit 7

CFB at Visit 8

CFB at Visit 9

CFB at Visit 10

CFB at Visit 11

CFB at Visit 12

CFB at Visit 13

Change From Baseline (CFB) in ESR Values at Every Visit

Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit

Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit

Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit

Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit

Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit

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 were observed prospectively for a total duration of 12 months.

Overall Study

Trial Identification

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Study Description

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