Trial · NCT00651040
Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM
NCT00651040, Phase 3, Completed, Institute of Rheumatology, Prague; results first posted 2016-05-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM. Trials, record NCT00651040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00651040
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM
- NCT number
- NCT00651040
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 31 participants, actual
- Lead sponsor
- Institute of Rheumatology, Prague
- Conditions
- Polymyositis, Dermatomyositis
- Interventions
- Prednisone, Methotrexate
- First posted
- 2008-04-02
- Last updated
- 2016-05-12
- Results first posted
- 2016-05-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment. | 1 year | The primary endpoint which has benn measured was the total dose of glucocorticoids administered between baseline and the end of treatment. |
| Secondary | Assessment of Disease Activity and Damage,Muscle Strength and Endurance, Enzyme Levels, Glucocorticoid Side-effects, Dose, HAQ,SF-36, Treatment Failures | 1 year |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment. | 1 year | mg/kg | MEAN | |
| SECONDARY | Assessment of Disease Activity and Damage,Muscle Strength and Endurance, Enzyme Levels, Glucocorticoid Side-effects, Dose, HAQ,SF-36, Treatment Failures | 1 year |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment. | Prednison1 | 124 | Standard Deviation 65.7 | mg/kg | |
| The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment. | Prednison Methotrexate 2 | 135 | Standard Deviation 45.2 | mg/kg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1Prednison | 16 | |
| Overall Study | STARTED | 2Prednison MTX | 15 | |
| Overall Study | COMPLETED | 1Prednison | 13 | |
| Overall Study | COMPLETED | 2Prednison MTX | 14 | |
| Overall Study | NOT COMPLETED | 1Prednison | 3 | |
| Overall Study | NOT COMPLETED | 2Prednison MTX | 1 |
Source ClinicalTrials.gov
Adverse events26
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 | infection | Infections and infestations | 1 Prednison | 8 | 16 | |
| other | infection | Infections and infestations | 2 Prednison Methotrexate | 6 | 15 | |
| other | Musculoskeletal | Musculoskeletal and connective tissue disorders | 1 Prednison | 8 | 16 | |
| other | Musculoskeletal | Musculoskeletal and connective tissue disorders | 2 Prednison Methotrexate | 3 | 15 | |
| other | cardiovascular | Cardiac disorders | 1 Prednison | 2 | 16 | |
| other | cardiovascular | Cardiac disorders | 2 Prednison Methotrexate | 2 | 15 | |
| other | gastrointestinal | Gastrointestinal disorders | 1 Prednison | 2 | 16 | |
| other | gastrointestinal | Gastrointestinal disorders | 2 Prednison Methotrexate | 3 | 15 | |
| other | general | General disorders | 1 Prednison | 3 | 16 | |
| other | general | General disorders | 2 Prednison Methotrexate | 3 | 15 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1 Prednison | ||
| Total, all-cause mortality | 2 Prednison Methotrexate | ||
| Total, other adverse events | 1 Prednison | 14 | 16 |
| Total, other adverse events | 2 Prednison Methotrexate | 11 | 15 |
| Total, serious adverse events | 1 Prednison | 4 | 16 |
| Total, serious adverse events | 2 Prednison Methotrexate | 5 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| 1 Prednison vs 2 Prednison Methotrexate: 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.
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/NCT00651040
GET https://conductscience.org/api/trials/v1/NCT00651040/events?page=2