Trial · NCT00504348
Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus
NCT00504348, Phase 2, Phase 3, Completed, Tokyo Medical and Dental University; results first posted 2020-03-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus. Trials, record NCT00504348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00504348
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus
- NCT number
- NCT00504348
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 25 participants, actual
- Lead sponsor
- Tokyo Medical and Dental University
- Conditions
- Interstitial Pneumonitis, Polymyositis, Dermatomyositis
- Interventions
- Tacrolimus
- First posted
- 2007-07-20
- Last updated
- 2020-03-24
- Results first posted
- 2020-03-24
- Limitations and caveats
Conclusion is not based on meaningful statistical comparison, will not apply to asymptomatic or subclinical IP, or to the exacerbation of IP, or will not separately provide the efficacy of the treatment in the anti-MDA-5 positive subgroup.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 52 weeks | Overall survival (OS) was calculated from the day on which the protocol treatment was started until death due to any cause. Participants still alive were censored at the date they were last known to be alive. |
| Secondary | Progression-free Survival | 52 weeks | Patients were considered to have reached the progression if they died, or if they met all the following criteria; (1) ≥10% decline from baseline FVC or ≥15mmHg increase in baseline resting P(A-a)O2, (2) a worsening of interstitial pneumonitis findings by chest CT compared to the most recent study, confirmed by a radiologist, and (3) exclusion of pneumocystis pneumonia, cytomegalovirus pneumonia, and other pulmonary infection on clinical ground. |
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 | Overall Survival | 52 weeks | percentage of participants | NUMBER | |
| SECONDARY | Progression-free Survival | 52 weeks | percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Overall Survival | Prospective Investigation Group | 88.0 | 95% Confidence Interval 67.3 to 96.0 | percentage of participants | |
| Progression-free Survival | Prospective Investigation Group | 76.4 | 95% Confidence Interval 51.8 to 89.5 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prospective Investigation Group | 25 | |
| Overall Study | COMPLETED | Prospective Investigation Group | 17 | |
| Overall Study | NOT COMPLETED | Prospective Investigation Group | 8 |
Source ClinicalTrials.gov
Adverse events70
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 | Nasopharyngitis | Infections and infestations | Prospective Investigation Group | 6 | 25 | 8 |
| other | Zoster | Infections and infestations | Prospective Investigation Group | 4 | 25 | 5 |
| other | Bronchitis | Infections and infestations | Prospective Investigation Group | 2 | 25 | 2 |
| other | Cystitis | Infections and infestations | Prospective Investigation Group | 2 | 25 | 2 |
| other | Gastroenteritis | Infections and infestations | Prospective Investigation Group | 2 | 25 | 2 |
| other | Onychomycosis | Infections and infestations | Prospective Investigation Group | 2 | 25 | 2 |
| other | Oral candidiasis | Infections and infestations | Prospective Investigation Group | 2 | 25 | 2 |
| other | Pharyngeal candidiasis | Infections and infestations | Prospective Investigation Group | 2 | 25 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Prospective Investigation Group | 3 | 25 | 3 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Prospective Investigation Group | 2 | 25 | 2 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prospective Investigation Group | 4 | 25 |
| Total, other adverse events | Prospective Investigation Group | 25 | 25 |
| Total, serious adverse events | Prospective Investigation Group | 11 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31539061 | RESULT |
Source PubMed
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/NCT00504348
GET https://conductscience.org/api/trials/v1/NCT00504348/events?page=2