Trial · NCT00323960
Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis
NCT00323960, Phase 3, Completed, Istituto Giannina Gaslini; results first posted 2021-03-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis. Trials, record NCT00323960. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00323960
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis
- NCT number
- NCT00323960
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 139 participants, actual
- Lead sponsor
- Istituto Giannina Gaslini
- Conditions
- Juvenile Dermatomyositis
- Interventions
- 3 MPDN pulse + PDN, 3 MPDN pulse + PDN + CSA, 3 MPDN pulse + PDN + MTX
- First posted
- 2006-05-10
- Last updated
- 2023-03-28
- Results first posted
- 2021-03-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Responder Status Defined as 20% Improvement in at Least 3 Core Set Variables With no More Than 1 of the Remaining Variables, (Muscle Strength Excluded), Worsened by > 30%. | 6 months | The PRINTO Juvenile Dermatomyositis (JDM) core set variables are: 1. muscle strength by the mean of the Childhood Myositis Assessment Scale (CMAS); 2. physician's global assessment of disease activity on a 10 cm Visual Analogue Scale (VAS); 3. global disease activity assessment by the mean of the Disease Activity Index (DAS); 4. parent's/patient's global assessment of overall well-being on a 10 cm VAS; 5. functional ability assessment by the mean of the Childhood Health Assessment Questionnaire (CHAQ) 6. health-related quality of life assessment. |
| Primary | Time to Clinical Remission | 60 months | Clinical remission is defined as the status of inactive disease for at least 6 continuous months defined as normal muscle strength (CMAS equal to 52) and physician global assessment of disease activity equal to 0. |
| Secondary | Time to Major Therapeutic Changes | 60 months | Time to major therapeutic changes is defined as the addition of CSA or MTX or any other disease-modifying antirheumatic drug (DMARS) in any of the 3 groups or discontinuation of assigned therapy for any reason including adverse events. Retention on treatment was used as main measure of effectiveness. |
| Secondary | Time to Prednisone, or Equivalent, Discontinuation | 60 months | Prednisone or equivalent glucocorticoid discontinuation is defined as the complete discontinuation of glucocorticoids |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Responder Status Defined as 20% Improvement in at Least 3 Core Set Variables With no More Than 1 of the Remaining Variables, (Muscle Strength Excluded), Worsened by > 30%. | 6 months | Comparison between group 2 (PDN+CSA) and 3 (PDN+MTX) combined versus group 1 (PDN) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time to Clinical Remission | 60 months | events per 1000 persons-time | NUMBER | |
| SECONDARY | Time to Major Therapeutic Changes | 60 months | events per 1000 persons-time | NUMBER | |
| SECONDARY | Time to Prednisone, or Equivalent, Discontinuation | 60 months | events per 1000 persons-time | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Responder Status Defined as 20% Improvement in at Least 3 Core Set Variables With no More Than 1 of the Remaining Variables, (Muscle Strength Excluded), Worsened by > 30%. | Group 1 (MPDN+PDN) | 24 | Participants | ||
| Responder Status Defined as 20% Improvement in at Least 3 Core Set Variables With no More Than 1 of the Remaining Variables, (Muscle Strength Excluded), Worsened by > 30%. | Group 2 (MPDN+PDN+CSA) | 32 | Participants | ||
| Responder Status Defined as 20% Improvement in at Least 3 Core Set Variables With no More Than 1 of the Remaining Variables, (Muscle Strength Excluded), Worsened by > 30%. | Group 3 (MPDN+PDN+MTX) | 33 | Participants | ||
| Time to Clinical Remission | Group 1 (MPDN+PDN) | 5.99 | 95% Confidence Interval 3.00 to 11.98 | events per 1000 persons-time | |
| Time to Clinical Remission | Group 2 (MPDN+PDN+CSA) | 4.95 | 95% Confidence Interval 2.36 to 10.38 | events per 1000 persons-time | |
| Time to Clinical Remission | Group 3 (MPDN+PDN+MTX) | 13.39 | 95% Confidence Interval 8.07 to 22.21 | events per 1000 persons-time | |
| Time to Major Therapeutic Changes | Group 1 (MPDN+PDN) | 30.52 | 95% Confidence Interval 21.34 to 43.65 | events per 1000 persons-time | |
| Time to Major Therapeutic Changes | Group 2 (MPDN+PDN+CSA) | 17.52 | 95% Confidence Interval 11.31 to 27.16 | events per 1000 persons-time | |
| Time to Major Therapeutic Changes | Group 3 (MPDN+PDN+MTX) | 13.92 | 95% Confidence Interval 8.65 to 22.39 | events per 1000 persons-time | |
| Time to Prednisone, or Equivalent, Discontinuation | Group 1 (MPDN+PDN) | 15.91 | 95% Confidence Interval 10.15 to 24.94 | events per 1000 persons-time |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methylprednisolone Pulse+Prednisone | 47 | |
| Overall Study | STARTED | Methylprednisolone Pulse+Prednisone+Cyclosporine A | 46 | |
| Overall Study | STARTED | Methylprednisolone Pulses+Prednisone+Methotrexate | 46 | |
| Overall Study | COMPLETED | Methylprednisolone Pulse+Prednisone | 47 | |
| Overall Study | COMPLETED | Methylprednisolone Pulse+Prednisone+Cyclosporine A | 46 | |
| Overall Study | COMPLETED | Methylprednisolone Pulses+Prednisone+Methotrexate | 46 | |
| Overall Study | NOT COMPLETED | Methylprednisolone Pulse+Prednisone | 0 | |
| Overall Study | NOT COMPLETED | Methylprednisolone Pulse+Prednisone+Cyclosporine A | 0 | |
| Overall Study | NOT COMPLETED | Methylprednisolone Pulses+Prednisone+Methotrexate | 0 |
Source ClinicalTrials.gov
Adverse events75
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 | Hypertrichosis | Skin and subcutaneous tissue disorders | MPDN+PDN | 5 | 47 | |
| other | Hypertrichosis | Skin and subcutaneous tissue disorders | MPDN+PDN+CSA | 8 | 46 | |
| other | Hypertrichosis | Skin and subcutaneous tissue disorders | MPDN+PDN+MTX | 1 | 46 | |
| other | Hirsutism | Skin and subcutaneous tissue disorders | MPDN+PDN | 1 | 47 | |
| other | Hirsutism | Skin and subcutaneous tissue disorders | MPDN+PDN+CSA | 11 | 46 | |
| other | Hirsutism | Skin and subcutaneous tissue disorders | MPDN+PDN+MTX | 1 | 46 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | MPDN+PDN | 1 | 47 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | MPDN+PDN+CSA | 4 | 46 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | MPDN+PDN+MTX | 2 | 46 | |
| other | Nausea | Gastrointestinal disorders | MPDN+PDN | 3 | 47 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MPDN+PDN | ||
| Total, all-cause mortality | MPDN+PDN+CSA | ||
| Total, all-cause mortality | MPDN+PDN+MTX | ||
| Total, other adverse events | MPDN+PDN | 29 | 47 |
| Total, other adverse events | MPDN+PDN+CSA | 35 | 46 |
| Total, other adverse events | MPDN+PDN+MTX | 29 | 46 |
| Total, serious adverse events | MPDN+PDN | 1 | 47 |
| Total, serious adverse events | MPDN+PDN+CSA | 5 | 46 |
| Total, serious adverse events | MPDN+PDN+MTX | 2 | 46 |
Source ClinicalTrials.gov
Papers7
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00323960
GET https://conductscience.org/api/trials/v1/NCT00323960/events?page=2