Trial · NCT01941095
A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis
NCT01941095, Phase 3, Completed, Hoffmann-La Roche; results first posted 2018-11-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis. Trials, record NCT01941095. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01941095
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis
- NCT number
- NCT01941095
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 100 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Rheumatoid Arthritis
- Interventions
- Azathioprine, Chloroquine, Hydroxychloroquine, Leflunomide, Methotrexate, Sulfasalazine, Tocilizumab
- First posted
- 2013-09-13
- Last updated
- 2018-11-13
- Other registries' IDs
- eudract:2013-000359-42
- Results first posted
- 2018-11-13
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at Week 24 | Week 24 | DAS28-ESR score is a measure of participant's disease activity calculated using tender joint count in 28 joints (TJC28), swollen joint count in 28 joints (SJC28), patient global assessment of disease activity (PGA) (general health \[GH\]) using visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in millimeters per hour \[mm/hr\]). The score is calculated using the following formula: DAS28-ESR = \[0.56 multiplied by (\*) square root (√) of TJC28\] plus (+) \[0.28\*√SJC28\]+\[0.70\*the natural logarithm (ln) ESR\]+\[0.014\*GH\]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. DAS28-ESR score of less than (\<) 2.6 represents DAS28-ESR remission. |
| Secondary | Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 | Weeks 24, 28, 32, 36, 40, 44, 48, 52 | DAS28-ESR score is a measure of participant's disease activity calculated using TJC28, SJC28, PGA using VAS 0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in mm/hr) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28-ESR = \[0.56 \* √TJC28 + \[0.28\*√SJC28\]+\[0.70\*ln ESR\]+\[0.014\*GH\]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. DAS28-ESR score \<2.6 represents DAS28-ESR remission. The percentage reported for Week 24 is based on confirmation on switching to SC tocilizumab monotherapy. |
| Secondary | Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 | Weeks 28, 32, 36, 40, 44, 48, 52 | DAS28-ESR score is a measure of participant's disease activity calculated using TJC28, SJC28, PGA using VAS 0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in mm/hr) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28-ESR = \[0.56 \* √TJC28 + \[0.28\*√SJC28\]+\[0.70\*ln ESR\]+\[0.014\*GH\]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. DAS28-ESR score \<2.6 represents DAS28-ESR remission. DAS28-ESR score greater than or equal to (\>/=) 2.6 and \<3.2 represents LDA. |
| Secondary | Change From Baseline in DAS28-ESR up to Week 52 | Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | DAS28-ESR score is a measure of participant's disease activity calculated using TJC28, SJC28, PGA using VAS 0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in mm/hr) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28-ESR = \[0.56 \* √TJC28 + \[0.28\*√SJC28\]+\[0.70\*ln ESR\]+\[0.014\*GH\]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. A negative change from baseline indicates an improvement. |
| Secondary | Number of Participants With American College of Rheumatology 20 (ACR20) Response | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | ACR20 response was defined as \>/=20% improvement from baseline in both TJC28 and SJC28 as well as in 3 out of 5 additional parameters: Separate patient and physician's global assessment of disease activity on VAS (0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS), patient's assessment of pain on VAS (0 mm=no pain to 100 mm=unbearable pain, displayed on the 100 mm horizontal VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI) (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without any difficulty to 3=unable to do), and acute phase response (ESR in mm/hr, for a total possible score of 0 to 10). |
| Secondary | Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Response to treatment was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from the baseline visit. Participants with a score lesser than or equal to (\</=) 3.2 and reduction of greater than (\>) 1.2 points were assessed as having a 'good' response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score \</=5.1 with reduction of \>0.6 to \</=1.2 points, were assessed as having a 'moderate' response. Participants with a score \>5.1 with reduction of \>0.6 to \</=1.2 points, or any score with reduction \</=0.6 points, were assessed as having 'no response'. |
| Secondary | Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 | Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | SDAI is an index for measuring disease activity. SDAI is the numerical sum of five outcome parameters: TJC28 and SJC28, PGA and physician global assessment of disease activity assessed on VAS (0 centimeter \[cm\]-10 cm); 0 cm= no disease activity and 10 cm= worst disease activity, and CRP (in milligrams per deciliter \[mg/dL\]). SDAI total score ranges from 0 to 86, with higher scores indicating increased (or severe) disease activity. SDAI score \</=3.3 indicates clinical remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high (or severe) disease activity. |
| Secondary | Change From Baseline in TJC28 up to Week 52 | Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | 28 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28. A negative change from baseline indicated improvement. |
| Secondary | Change From Baseline in SJC28 up to Week 52 | Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | 28 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28. A negative change from baseline indicated improvement. |
| Secondary | Percentage of Participants With Corticosteroid Dose Reduction or Discontinuation | From Baseline up to Week 52 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at Week 24 | Week 24 | Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 | Weeks 24, 28, 32, 36, 40, 44, 48, 52 | Per protocol analysis. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 | Weeks 28, 32, 36, 40, 44, 48, 52 | Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in DAS28-ESR up to Week 52 | Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint. | units on a scale | MEAN |
| SECONDARY | Number of Participants With American College of Rheumatology 20 (ACR20) Response | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 | Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in TJC28 up to Week 52 | Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint. | tender joints | MEAN |
| SECONDARY | Change From Baseline in SJC28 up to Week 52 | Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint. | swollen joints | MEAN |
| SECONDARY | Percentage of Participants With Corticosteroid Dose Reduction or Discontinuation | From Baseline up to Week 52 | Full analysis set. Overall number of participants analyzed = participants who used corticosteroids during the study. | percentage of participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group244
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at Week 24 | Tocilizumab | 40 | percentage of participants | ||
| Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 | Tocilizumab | Week 24 | 38.7 | percentage of participants | |
| Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 | Tocilizumab | Week 28 | 34.2 | percentage of participants | |
| Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 | Tocilizumab | Week 32 | 36.5 | percentage of participants | |
| Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 | Tocilizumab | Week 36 | 36.5 | percentage of participants | |
| Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 | Tocilizumab | Week 40 | 36.5 | percentage of participants | |
| Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 | Tocilizumab | Week 44 | 35.2 | percentage of participants | |
| Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 | Tocilizumab | Week 48 | 35.7 | percentage of participants | |
| Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 | Tocilizumab | Week 52 | 38.8 | percentage of participants | |
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 | Tocilizumab | Week 28: Remission | 5.1 | percentage of participants |
1 to 10 of 244Source ClinicalTrials.gov
See all 244 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tocilizumab | 97 | |
| Overall Study | COMPLETED | Tocilizumab | 41 | |
| Overall Study | NOT COMPLETED | Tocilizumab | 56 |
Source ClinicalTrials.gov
Adverse events80
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 | Events |
|---|---|---|---|---|---|---|
| other | Leukopenia | Blood and lymphatic system disorders | Tocilizumab Monotherapy | 4 | 31 | |
| other | Leukopenia | Blood and lymphatic system disorders | Tocilizumab + Methotrexate or Other Non-Biologic DMARDs | 8 | 66 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Tocilizumab Monotherapy | 1 | 31 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Tocilizumab + Methotrexate or Other Non-Biologic DMARDs | 4 | 66 | |
| other | Neutropenia | Blood and lymphatic system disorders | Tocilizumab Monotherapy | 6 | 31 | |
| other | Neutropenia | Blood and lymphatic system disorders | Tocilizumab + Methotrexate or Other Non-Biologic DMARDs | 5 | 66 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tocilizumab Monotherapy | 2 | 31 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tocilizumab + Methotrexate or Other Non-Biologic DMARDs | 4 | 66 | |
| other | Diarrhoea | Gastrointestinal disorders | Tocilizumab Monotherapy | 2 | 31 | |
| other | Diarrhoea | Gastrointestinal disorders | Tocilizumab + Methotrexate or Other Non-Biologic DMARDs | 2 | 66 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tocilizumab Monotherapy | ||
| Total, all-cause mortality | Tocilizumab + Methotrexate or Other Non-Biologic DMARDs | ||
| Total, other adverse events | Tocilizumab Monotherapy | 19 | 31 |
| Total, other adverse events | Tocilizumab + Methotrexate or Other Non-Biologic DMARDs | 38 | 66 |
| Total, serious adverse events | Tocilizumab Monotherapy | 2 | 31 |
| Total, serious adverse events | Tocilizumab + Methotrexate or Other Non-Biologic DMARDs | 5 | 66 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tocilizumab Monotherapy vs Tocilizumab + Methotrexate or Other Non-Biologic DMARDs: serious adverse events |
Source 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.
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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