Trial · NCT01041248
Single Patient Study to Treat Relapsing Polychondritis With Tocilizumab
NCT01041248, Not applicable, Completed, Children's Hospital of Eastern Ontario; results first posted 2021-03-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Single Patient Study to Treat Relapsing Polychondritis With Tocilizumab. Trials, record NCT01041248. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01041248
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Single Patient Study to Treat Relapsing Polychondritis With Tocilizumab
- NCT number
- NCT01041248
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1 participants, actual
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Conditions
- Relapsing Polychondritis
- Interventions
- Tocilizumab
- First posted
- 2009-12-31
- Last updated
- 2021-03-03
- Results first posted
- 2021-03-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Physician Global Assessment of Disease Activity | Baseline and then every 2 weeks prior to each infusion for total duration of 30 weeks | Physician global assessment of disease activity was assessed on a 100 mm Visual Analogue Scale where 0 would be no disease activity and 100 would be the maximum disease activity. Higher values therefore indicate higher disease activity and therefore a worse outcome. Change of this outcome measure over time was documented. |
| Secondary | Prednisone Dose | 30 weeks | Prednisone dose administered to patient reduction through treatment course |
| Secondary | Parent/Patient Global Assessment of Overall Well Being | 30 weeks | A 100 mm visual analogue scale was used for the assessment of the parent/patient globale well being, maximum value is 100 and minimum value is 0 with lower values being better well being and therefore improved outcome and higher values worse well being and therefore worse outcome. Changes in this score over time are being assessed with this measure. |
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 | Physician Global Assessment of Disease Activity | Baseline and then every 2 weeks prior to each infusion for total duration of 30 weeks | a known patient for whom this trial was designed was recruited into this open label single arm study | mm | NUMBER |
| SECONDARY | Prednisone Dose | 30 weeks | single arm open label study for 1 patient with relapsing polychondritis | mg | NUMBER |
| SECONDARY | Parent/Patient Global Assessment of Overall Well Being | 30 weeks | Patient receiving Tocilizumab | mm | NUMBER |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Physician Global Assessment of Disease Activity | Tocilizumab | Baseline | 21 | mm | |
| Physician Global Assessment of Disease Activity | Tocilizumab | 2 weeks | 14 | mm | |
| Physician Global Assessment of Disease Activity | Tocilizumab | 4 weeks | 12 | mm | |
| Physician Global Assessment of Disease Activity | Tocilizumab | 6 weeks | 43 | mm | |
| Physician Global Assessment of Disease Activity | Tocilizumab | 8 weeks | 14 | mm | |
| Physician Global Assessment of Disease Activity | Tocilizumab | 10 weeks | 12 | mm | |
| Physician Global Assessment of Disease Activity | Tocilizumab | 12 weeks | 8 | mm | |
| Physician Global Assessment of Disease Activity | Tocilizumab | 14 weeks | 6 | mm | |
| Physician Global Assessment of Disease Activity | Tocilizumab | 16 weeks | 5 | mm | |
| Physician Global Assessment of Disease Activity | Tocilizumab | 18 weeks | 8 | mm |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tocilizumab | 1 | |
| Overall Study | COMPLETED | Tocilizumab | 1 | |
| Overall Study | NOT COMPLETED | Tocilizumab | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tocilizumab | 0 | 1 |
| Total, other adverse events | Tocilizumab | 0 | 1 |
| Total, serious adverse events | Tocilizumab | 0 | 1 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19106169 | BACKGROUND |
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/NCT01041248
GET https://conductscience.org/api/trials/v1/NCT01041248/results?page=2