Trial · NCT02043548
Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis
NCT02043548, Phase 2, Completed, Chester Oddis; results first posted 2020-10-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis. Trials, record NCT02043548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02043548
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis
- NCT number
- NCT02043548
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Chester Oddis
- Conditions
- Dermatomyositis, Polymyositis
- Interventions
- tocilizumab, placebo
- First posted
- 2014-01-23
- Last updated
- 2020-10-30
- Results first posted
- 2020-10-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Compare the Average Total Improvement Scores at Visits 2 Through 7 During the 6-month Treatment Period Between the Treatment and Placebo Arms | Week 4, 8, 12, 16, 20, and 24 | The total improvement score was calculated by adding the improvement scores of all six core set measures based on 2016 American College of Rheumatology (ACR)/European League Against Rheumatism(EULAR) myositis response criteria. The minimum and maximum values of the average Total Improvement Scores are 0 and 100; The minimum and maximum values of the average Total Improvement Scores of our included patients are 5.0 and 67.1; The higher scores mean a better outcome. |
| Secondary | Comparison of the Time to First Definition of Improvement (DOI) Between the 2 Arms | Week 4, 8, 12, 16, 20, and 24 | Time to achieve the first DOI between the treatment and placebo arms.The total improvement score (TIS) is the sum of all 6 improvement scores associated with the change in each core set measure. A TIS \>= 20 represents minimal improvement, a score of \>=40 represents moderate improvement, and a score of \>=60 represents major improvement. |
| Secondary | Count of the Adverse Events Between the Treatment and Placebo Arms. | Week 4, 8, 12, 16, 20, and 24 | We compared the count of the adverse events between the treatment and placebo arms statistically. |
| Secondary | Comparison of the Steroid-sparing Effect (Calculated Using Prednisone Dose Equivalents) Between the Treatment and Placebo Arms | Week 4, 8, 12, 16, 20, and 24 | Mean change of steroid dose prednisone equivalent from last visit to baseline visit was compared between the two treatment arms |
| Secondary | Comparison of Individual Average Core Set Measure in Subjects Over Time Between the 2 Arms (Repeated Measures Analysis) | Week 4, 8, 12, 16, 20, and 24 | The core set measure tested was manual muscle testing, and we compared the mean manual muscle test measures in subjects over time. The minimum and maximum values of the manual muscle testing are 0 and 150; The minimum and maximum values of the manual muscle testing of our included patients are 97.0 and 150.0; The higher scores mean a better outcome. |
| Secondary | Magnitude of the Effect Size Between the Both Treatment Arms | Week 4, 8, 12, 16, 20, and 24 | Compared the number of subjects meeting total improvement scores \>=20 (minimal) and \>=40 (moderate) and \>=60 (major) based on 2016 ACR EULAR myositis response criteria for treatment group and placebo group. The highest TIS score achieved from week 4 through week 24 was used to determine the effect size between both treatment arms. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Compare the Average Total Improvement Scores at Visits 2 Through 7 During the 6-month Treatment Period Between the Treatment and Placebo Arms | Week 4, 8, 12, 16, 20, and 24 | All participants randomized are included in intention to treat analysis | score on a scale | MEAN |
| SECONDARY | Comparison of the Time to First Definition of Improvement (DOI) Between the 2 Arms | Week 4, 8, 12, 16, 20, and 24 | days | MEDIAN | |
| SECONDARY | Count of the Adverse Events Between the Treatment and Placebo Arms. | Week 4, 8, 12, 16, 20, and 24 | events | NUMBER | |
| SECONDARY | Comparison of the Steroid-sparing Effect (Calculated Using Prednisone Dose Equivalents) Between the Treatment and Placebo Arms | Week 4, 8, 12, 16, 20, and 24 | Only 33 of the total 36 patients were included in analysis due to missing data on three participants. | mg | MEDIAN |
| SECONDARY | Comparison of Individual Average Core Set Measure in Subjects Over Time Between the 2 Arms (Repeated Measures Analysis) | Week 4, 8, 12, 16, 20, and 24 | score on a scale | MEAN | |
| SECONDARY | Magnitude of the Effect Size Between the Both Treatment Arms | Week 4, 8, 12, 16, 20, and 24 | The total improvement score was calculated at each timepoint (weeks 4, 8, 12,16, 20 and 24) for each subject. The greatest improvement score achieved for each subject between week 4 through week 24 was reported (minimal, moderate or major improvement). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Compare the Average Total Improvement Scores at Visits 2 Through 7 During the 6-month Treatment Period Between the Treatment and Placebo Arms | Group A: Tocilizumab | 26.4 | Standard Deviation 16.8 | score on a scale | |
| Compare the Average Total Improvement Scores at Visits 2 Through 7 During the 6-month Treatment Period Between the Treatment and Placebo Arms | Group B: Placebo | 29.3 | Standard Deviation 16.8 | score on a scale | |
| Comparison of the Time to First Definition of Improvement (DOI) Between the 2 Arms | Group A: Tocilizumab | 42.4 | Inter-Quartile Range 27.5 to 90.4 | days | |
| Comparison of the Time to First Definition of Improvement (DOI) Between the 2 Arms | Group B: Placebo | 55.5 | Inter-Quartile Range 29.4 to 114.6 | days | |
| Count of the Adverse Events Between the Treatment and Placebo Arms. | Group A: Tocilizumab | 14 | events | ||
| Count of the Adverse Events Between the Treatment and Placebo Arms. | Group B: Placebo | 9 | events | ||
| Comparison of the Steroid-sparing Effect (Calculated Using Prednisone Dose Equivalents) Between the Treatment and Placebo Arms | Group A: Tocilizumab | 0.0 | Inter-Quartile Range 0 to 0 | mg | |
| Comparison of the Steroid-sparing Effect (Calculated Using Prednisone Dose Equivalents) Between the Treatment and Placebo Arms | Group B: Placebo | 0.0 | Inter-Quartile Range 0 to 5 | mg | |
| Comparison of Individual Average Core Set Measure in Subjects Over Time Between the 2 Arms (Repeated Measures Analysis) | Group A: Tocilizumab | 130.7 | Standard Deviation 16.94 | score on a scale | |
| Comparison of Individual Average Core Set Measure in Subjects Over Time Between the 2 Arms (Repeated Measures Analysis) | Group B: Placebo | 137.3 | Standard Deviation 11.83 | score on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A: Tocilizumab | 18 | |
| Overall Study | STARTED | Group B: Placebo | 18 | |
| Overall Study | COMPLETED | Group A: Tocilizumab | 17 | |
| Overall Study | COMPLETED | Group B: Placebo | 17 | |
| Overall Study | NOT COMPLETED | Group A: Tocilizumab | 1 | |
| Overall Study | NOT COMPLETED | Group B: Placebo | 1 |
Source ClinicalTrials.gov
Adverse events20
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 | General disorders and administration site conditions | Injury, poisoning and procedural complications | Group A: Tocilizumab | 1 | 18 | 1 |
| other | General disorders and administration site conditions | Injury, poisoning and procedural complications | Group B: Placebo | 0 | 18 | 0 |
| other | Sinusitis | Infections and infestations | Group A: Tocilizumab | 4 | 18 | 5 |
| other | Sinusitis | Infections and infestations | Group B: Placebo | 3 | 18 | 4 |
| other | Upper Respiratory Infection | Infections and infestations | Group A: Tocilizumab | 3 | 18 | 3 |
| other | Upper Respiratory Infection | Infections and infestations | Group B: Placebo | 1 | 18 | 1 |
| other | Herpes Zoster | Infections and infestations | Group A: Tocilizumab | 0 | 18 | 0 |
| other | Herpes Zoster | Infections and infestations | Group B: Placebo | 2 | 18 | 2 |
| other | Depression | Psychiatric disorders | Group A: Tocilizumab | 1 | 18 | 1 |
| other | Depression | Psychiatric disorders | Group B: Placebo | 0 | 18 | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A: Tocilizumab | 0 | 18 |
| Total, all-cause mortality | Group B: Placebo | 0 | 18 |
| Total, other adverse events | Group A: Tocilizumab | 11 | 18 |
| Total, other adverse events | Group B: Placebo | 8 | 18 |
| Total, serious adverse events | Group A: Tocilizumab | 1 | 18 |
| Total, serious adverse events | Group B: Placebo | 0 | 18 |
Source ClinicalTrials.gov
Papers14
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A: Tocilizumab vs Group B: Placebo: deaths from any cause | Trial comparisons |
| Group A: Tocilizumab vs Group B: Placebo: 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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02043548
GET https://conductscience.org/api/trials/v1/NCT02043548/registered