Trial · NCT00106184
Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM)
NCT00106184, Phase 2, Completed, University of Pittsburgh; results first posted 2015-03-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM). Trials, record NCT00106184. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00106184
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM)
- NCT number
- NCT00106184
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 200 participants, actual
- Lead sponsor
- University of Pittsburgh
- Conditions
- Myositis, Dermatomyositis, Polymyositis, Juvenile Dermatomyositis
- Interventions
- Rituximab, Placebo
- First posted
- 2005-03-22
- Last updated
- 2015-03-04
- Results first posted
- 2015-03-04
- Limitations and caveats
- There was an overestimate of the rapidity of the rituximab response and an underestimate of DOI in those receiving placebo.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison Between the Time to Improvement Between the Two Groups of IIM (Idiopathic Inflammatory Myopathy) Patients | Week 44 of treatment phase | The Definition of Improvement for both adult and pediatric patients will be: 3 of any of the 6 core set measures improved by ≥ 20%, with no more than 2 of the core set measures worsening by ≥25% (worsening measure cannot include the MMT) at two consecutive visits. Of note, the MMT could not be one of the worsening measures. Core Set Measures Included: 1. Manual Muscle Testing (MMT)- Muscle Strength 2. Physician Global Disease Activity VAS Score 3. Health Assessment Questionnaire Index Score - Physical Function 4. Patient Global Assessment of Disease Activity VAS score 5. Extramuscular Activity - Myositis Disease Activity Assessment Tool 6. 2 or more elevated muscle enzymes (Aldolase, CK, AST, ALT, and LDH) |
| Secondary | Response Rates (Proportion of Improved Patients) Between Groups A (Rituximab Wks 0 and 1) and B (Rituximab Wks 8 and 9) at Week 8 | Week 8 of the treatment phase | The Definition of Improvement for both adult and pediatric patients will be: 3 of any of the 6 core set measures improved by ≥ 20%, with no more than 2 of the core set measures worsening by ≥25% (worsening measure cannot include the MMT) at two consecutive visits. Of note, the MMT could not be one of the worsening measures. Core Set Measures Included: 1. Manual Muscle Testing (MMT)- Muscle Strength 2. Physician Global Disease Activity VAS Score 3. Health Assessment Questionnaire Index Score - Physical Function 4. Patient Global Assessment of Disease Activity VAS score 5. Extramuscular Activity - Myositis Disease Activity Assessment Tool 6. 2 or more elevated muscle enzymes (Aldolase, CK, AST, ALT, and LDH) |
| Secondary | 20% Improvement in Manual Muscle Testing (MMT) Over Baseline on Two Consecutive Time Points (Muscle is the Primary Organ of Involvement, and MMT is the One Objective Measurement of the Definition of Improvement [DOI]) | Week 44 of treatment phase | Number of participants with a 20% improvement in MMT over baseline on two consecutive time points. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Comparison Between the Time to Improvement Between the Two Groups of IIM (Idiopathic Inflammatory Myopathy) Patients | Week 44 of treatment phase | Intention to Treat (ITT) | Weeks | MEDIAN |
| SECONDARY | Response Rates (Proportion of Improved Patients) Between Groups A (Rituximab Wks 0 and 1) and B (Rituximab Wks 8 and 9) at Week 8 | Week 8 of the treatment phase | Intention to Treat (ITT) | participants | NUMBER |
| SECONDARY | 20% Improvement in Manual Muscle Testing (MMT) Over Baseline on Two Consecutive Time Points (Muscle is the Primary Organ of Involvement, and MMT is the One Objective Measurement of the Definition of Improvement [DOI]) | Week 44 of treatment phase | Intention to Treat (ITT) | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Comparison Between the Time to Improvement Between the Two Groups of IIM (Idiopathic Inflammatory Myopathy) Patients | Group A (Rituximab Wks 0 and 1) | 20.2 | Full Range 8 to 44 | Weeks | |
| Comparison Between the Time to Improvement Between the Two Groups of IIM (Idiopathic Inflammatory Myopathy) Patients | Group B (Rituximab Wks 8 and 9) | 20.0 | Full Range 8 to 44 | Weeks | |
| Response Rates (Proportion of Improved Patients) Between Groups A (Rituximab Wks 0 and 1) and B (Rituximab Wks 8 and 9) at Week 8 | Treatment Group A (Rituximab Wks 0 and 1) | 14 | participants | ||
| Response Rates (Proportion of Improved Patients) Between Groups A (Rituximab Wks 0 and 1) and B (Rituximab Wks 8 and 9) at Week 8 | Treatment Group B (Rituximab Wks 8 and 9) | 21 | participants | ||
20% Improvement in Manual Muscle Testing (MMT) Over Baseline on Two Consecutive Time Points (Muscle is the Primary Organ of Involvement, and MMT is the One Objective Measurement of the Definition of Improvement [DOI]) | Treatment Group A (Rituximab Wks 0 and 1) | 14 | Participants | ||
20% Improvement in Manual Muscle Testing (MMT) Over Baseline on Two Consecutive Time Points (Muscle is the Primary Organ of Involvement, and MMT is the One Objective Measurement of the Definition of Improvement [DOI]) | Treatment Group B (Rituximab Wks 8 and 9) | 21 | Participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Group A (Rituximab Wks 0 and 1) | 96 | |
| Overall Study | STARTED | Treatment Group B (Rituximab Wks 8 and 9) | 104 | |
| Overall Study | Treated | Treatment Group A (Rituximab Wks 0 and 1) | 93 | |
| Overall Study | Treated | Treatment Group B (Rituximab Wks 8 and 9) | 102 | |
| Overall Study | COMPLETED | Treatment Group A (Rituximab Wks 0 and 1) | 93 | |
| Overall Study | COMPLETED | Treatment Group B (Rituximab Wks 8 and 9) | 102 | |
| Overall Study | NOT COMPLETED | Treatment Group A (Rituximab Wks 0 and 1) | 3 | |
| Overall Study | NOT COMPLETED | Treatment Group B (Rituximab Wks 8 and 9) | 2 |
Source ClinicalTrials.gov
Adverse events82
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 | Headache | General disorders | Treatment Group A | 13 | 96 | 13 |
| other | Headache | General disorders | Treatment Group B | 12 | 104 | 12 |
| other | Nausea | Gastrointestinal disorders | Treatment Group A | 10 | 96 | 10 |
| other | Nausea | Gastrointestinal disorders | Treatment Group B | 10 | 104 | 10 |
| other | Bronchitis | Infections and infestations | Treatment Group A | 6 | 96 | 6 |
| other | Bronchitis | Infections and infestations | Treatment Group B | 4 | 104 | 4 |
| other | Diarrhea | Gastrointestinal disorders | Treatment Group A | 6 | 96 | 6 |
| other | Diarrhea | Gastrointestinal disorders | Treatment Group B | 9 | 104 | 9 |
| other | Fever | General disorders | Treatment Group A | 6 | 96 | 6 |
| other | Fever | General disorders | Treatment Group B | 10 | 104 | 10 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Group A | ||
| Total, all-cause mortality | Treatment Group B | ||
| Total, other adverse events | Treatment Group A | 45 | 96 |
| Total, other adverse events | Treatment Group B | 55 | 104 |
| Total, serious adverse events | Treatment Group A | 24 | 96 |
| Total, serious adverse events | Treatment Group B | 41 | 104 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AR061298 | Mechanisms of Response and Relapse in Rituximab-treated Myositis Patients | ODDIS, CHESTER V; LEVESQUE, MARC C. | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2010 to 2013 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Treatment Group A (Rituximab Wks 0 and 1) vs Treatment Group B (Rituximab Wks 8 and 9): Response Rates (Proportion of Improved Patients) Between Groups A (Rituximab Wks 0 and 1) and B (Rituximab Wks 8 and 9) at Week 8 | Trial comparisons |
Treatment Group A (Rituximab Wks 0 and 1) vs Treatment Group B (Rituximab Wks 8 and 9): 20% Improvement in Manual Muscle Testing (MMT) Over Baseline on Two Consecutive Time Points (Muscle is the Primary Organ of Involvement, and MMT is the One Objective Measurement of the Definition of Improvement [DOI]) | Trial comparisons |
| Treatment Group A vs Treatment Group B: 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/NCT00106184
GET https://conductscience.org/api/trials/v1/NCT00106184/events?page=2