Trial · NCT01543503

An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

NCT01543503, Completed, Hoffmann-La Roche; results first posted 2016-02-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis. Trials, record NCT01543503. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01543503

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
NCT number: NCT01543503
Status: Completed
Enrollment: 1,225 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Rheumatoid Arthritis
First posted: 2012-03-05
Last updated: 2016-02-10
Results first posted: 2016-02-10

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24	Baseline and Week 24	Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker \[erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/h), or C-reactive protein (CRP) in milligram/liter (mg/L)\]. For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of less than or equal to (\</=) 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity.
Secondary	Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52	Baseline and Week 52	Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker (ESR in mm/h, or CRP in mg/L). For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of \</= 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity.
Secondary	Mean Change From Baseline in Erythrocyte Sedimentation Rate	Baseline, Week 24, Week 52	Blood samples were collected for ESR, which is an acute phase reactant and a measure of inflammation. BL = baseline.
Secondary	Mean Change From Baseline in C-reactive Protein	Baseline, Week 24, Week 52	Blood samples were collected for C-reactive protein (CRP). CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA.
Secondary	Mean Change From Baseline in Swollen Joint Count	Baseline, Week 24, Week 52	A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28.
Secondary	Mean Change From Baseline in Tender Joint Count	Baseline, Week 24, Week 52	A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.
Secondary	Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score	Baseline, Week 24, Week 52	Clinical Disease Activity Index (CDAI) was calculated as the sum of the following parameters: SJC + TJC + VAS Patient Global Assessment of Disease Activity + VAS Physician Global Assessment of Disease Activity. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. Simplified Disease Activity Index (SDAI) was calculated as the sum of the following parameters: SJC +TJC + Patient Global Assessment of Disease Activity + Physician Global Assessment of Disease Activity + CRP. SDAI scores ranged from 0 to 86, with higher scores also indicating increased disease activity.
Secondary	Mean Change From Baseline in Physician Global Assessment Score	Baseline, Week 24, Week 52	The Physician's Global Assessment of disease activity was assessed using a 0 to 100 millimeter (mm) horizontal VAS. 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, as "maximum disease activity" (maximum arthritis disease activity). Change from baseline = scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Secondary	Loss of Efficacy or Development of Intolerance to Biologic Therapy	Up to Week 52	Events that are clearly consistent with the expected pattern of progression of the underlying disease may contribute to lack of efficacy. Lack of efficacy was one of the reasons for termination of biology therapy. The number of participants showing lack of efficacy to biologic therapy is presented.
Secondary	Proportion of Participants Who Terminated Biologic Treatment	Up to Week 52	The proportion of participants who discontinued biologic treatment was compared between tocilizumab-treated and TNF inhibitor-treated participants.

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24	Baseline and Week 24	Participants belonging to the safety population who had first biologic administration within 60 days after the last Rheumatoid Arthritis (RA) disease activity assessment were included in the effectiveness analysis population. Data of participants available at the time of the assessment were included in the analysis.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52	Baseline and Week 52	The effectiveness analysis population was used for analysis. Data of participants available at the time of the assessment were included in the analysis.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Erythrocyte Sedimentation Rate	Baseline, Week 24, Week 52	The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.	mm/hr	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in C-reactive Protein	Baseline, Week 24, Week 52	The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point	mg/L	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Swollen Joint Count	Baseline, Week 24, Week 52	The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.	Number of swollen joints	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Tender Joint Count	Baseline, Week 24, Week 52	The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.	Number of tender joints	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score	Baseline, Week 24, Week 52	The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Physician Global Assessment Score	Baseline, Week 24, Week 52	The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Loss of Efficacy or Development of Intolerance to Biologic Therapy	Up to Week 52	The safety population included all recruited participants who received at least one dose of a TNF inhibitor or tocilizumab during the study.	participants	NUMBER
SECONDARY	Proportion of Participants Who Terminated Biologic Treatment	Up to Week 52	The safety population was used for analysis.	Percentage of participants	NUMBER

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group224

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24	Tocilizumab		-2.795	95% Confidence Interval -3.107 to -2.483	Units on a scale
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24	TNF Inhibitor		-1.945	95% Confidence Interval -2.249 to -1.640	Units on a scale
Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52	Tocilizumab		-3.015	95% Confidence Interval -3.279 to -2.751	units on a scale
Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52	TNF Inhibitor		-2.105	95% Confidence Interval -2.325 to -1.885	units on a scale
Mean Change From Baseline in Erythrocyte Sedimentation Rate	Tocilizumab	Change from BL to Week 24, n = 225, 456	-22.732	95% Confidence Interval -24.717 to -20.747	mm/hr
Mean Change From Baseline in Erythrocyte Sedimentation Rate	TNF Inhibitor	Change from BL to Week 24, n = 225, 456	-9.502	95% Confidence Interval -11.112 to -7.892	mm/hr
Mean Change From Baseline in Erythrocyte Sedimentation Rate	Tocilizumab	Change from BL to Week 52, n = 215, 411	-21.515	95% Confidence Interval -23.875 to -19.155	mm/hr
Mean Change From Baseline in Erythrocyte Sedimentation Rate	TNF Inhibitor	Change from BL to Week 52, n = 215, 411	-8.868	95% Confidence Interval -10.865 to -6.870	mm/hr
Mean Change From Baseline in C-reactive Protein	Tocilizumab	Change from BL to Week 24, n = 177, 396	-11.005	95% Confidence Interval -14.131 to -7.880	mg/L
Mean Change From Baseline in C-reactive Protein	TNF Inhibitor	Change from BL to Week 24, n = 177, 396	-4.333	95% Confidence Interval -6.859 to -1.807	mg/L

1 to 10 of 224Source ClinicalTrials.gov

See all 224 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tocilizumab	426
Overall Study	STARTED	TNF Inhibitor	798
Overall Study	COMPLETED	Tocilizumab	350
Overall Study	COMPLETED	TNF Inhibitor	711
Overall Study	NOT COMPLETED	Tocilizumab	76
Overall Study	NOT COMPLETED	TNF Inhibitor	87

Source ClinicalTrials.gov

Adverse events212

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	NEUTROPENIA	Blood and lymphatic system disorders	Tocilizumab	14	423
other	NEUTROPENIA	Blood and lymphatic system disorders	TNF Inhibitor	3	793
other	DIARRHOEA	Gastrointestinal disorders	Tocilizumab	4	423
other	DIARRHOEA	Gastrointestinal disorders	TNF Inhibitor	9	793
other	NAUSEA	Gastrointestinal disorders	Tocilizumab	9	423
other	NAUSEA	Gastrointestinal disorders	TNF Inhibitor	15	793
other	INJECTION SITE REACTION	General disorders	Tocilizumab	1	423
other	INJECTION SITE REACTION	General disorders	TNF Inhibitor	22	793
other	BRONCHITIS	Infections and infestations	Tocilizumab	11	423
other	BRONCHITIS	Infections and infestations	TNF Inhibitor	13	793

1 to 10 of 212Source ClinicalTrials.gov

See all 212 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tocilizumab
Total, all-cause mortality	TNF Inhibitor
Total, other adverse events	Tocilizumab	132	423
Total, other adverse events	TNF Inhibitor	231	793
Total, serious adverse events	Tocilizumab	22	423
Total, serious adverse events	TNF Inhibitor	64	793

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28622454	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tocilizumab vs TNF Inhibitor: Loss of Efficacy or Development of Intolerance to Biologic Therapy	Trial comparisons
Tocilizumab vs TNF Inhibitor: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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