Trial · NCT01396317
Study of Tocilizumab to Treat Polymyalgia Rheumatica
NCT01396317, Phase 2, Completed, Hospital for Special Surgery, New York; results first posted 2018-01-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Tocilizumab to Treat Polymyalgia Rheumatica. Trials, record NCT01396317. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01396317
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Tocilizumab to Treat Polymyalgia Rheumatica
- NCT number
- NCT01396317
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Hospital for Special Surgery, New York
- Conditions
- Polymyalgia Rheumatica (PMR)
- Interventions
- Tocilizumab
- First posted
- 2011-07-18
- Last updated
- 2018-01-17
- Results first posted
- 2018-01-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients in Disease Remission at Six Months From Trial Entry | Six months | The co-primary endpoints for this study include efficacy: • Efficacy will be defined by the proportion of patients in Disease Remission (DR) off corticosteroids, without relapse or recurrence, at six months from trial entry Relapse was defined as the reappearance of signs and symptoms of PMR, accompanied by an increasing erythrocyte sedimentation rate and/or C-reactive protein level attributable to disease activity. Recurrence was similarly defined as the return of PMR symptoms in conjunction with elevations in levels of inflammation markers, occurring 1 month after discontinuation of glucocorticoid therapy. |
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 15 months | The co-primary endpoints for this study include evaluations of safety and tolerability: • Safety and tolerability of Tocilizumab will be evaluated during the fifteen-month study period by the monitoring of adverse events and immunogenicity surveillance |
| Secondary | Proportion of Patients Able to Achieve Disease Remission (DR) Off Corticosteroids, Without Disease Relapse or Recurrence | 12 and 15 months from trial entry | |
| Secondary | Proportion of Patients Who Develop Disease Relapses | 6, 12 and 15 months from trial entry | Relapse was defined as the reappearance of signs and symptoms of PMR, accompanied by an increasing erythrocyte sedimentation rate and/or C-reactive\\ protein level attributable to disease activity. Recurrence was similarly defined as the return of PMR symptoms in conjunction with elevations in levels of inflammation markers, occurring 1 month after discontinuation of GC therapy. |
| Secondary | The Cumulative Dose of Prednisone | 6, 12 and 15 months from trial entry | |
| Secondary | Total Number of Relapses/Recurrences | 12 months |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients in Disease Remission at Six Months From Trial Entry | Six months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 15 months | Number of Adverse Events | NUMBER | |
| SECONDARY | Proportion of Patients Able to Achieve Disease Remission (DR) Off Corticosteroids, Without Disease Relapse or Recurrence | 12 and 15 months from trial entry | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Patients Who Develop Disease Relapses | 6, 12 and 15 months from trial entry | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Cumulative Dose of Prednisone | 6, 12 and 15 months from trial entry | milligrams | MEAN | |
| SECONDARY | Total Number of Relapses/Recurrences | 12 months | Incidents | 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 |
|---|---|---|---|---|---|
| Proportion of Patients in Disease Remission at Six Months From Trial Entry | Tocilizumab + Corticosteroid Taper | 9 | Participants | ||
| Proportion of Patients in Disease Remission at Six Months From Trial Entry | Control (Corticosteroid Taper Alone) | 0 | Participants | ||
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Tocilizumab | Adverse Events | 23 | Number of Adverse Events | |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Tocilizumab | Serious Adverse Events | 1 | Number of Adverse Events | |
| Proportion of Patients Able to Achieve Disease Remission (DR) Off Corticosteroids, Without Disease Relapse or Recurrence | Tocilizumab + Corticosteroid Taper | 9 | Participants | ||
| Proportion of Patients Able to Achieve Disease Remission (DR) Off Corticosteroids, Without Disease Relapse or Recurrence | Control (Corticosteroid Taper Alone) | 0 | Participants | ||
| Proportion of Patients Who Develop Disease Relapses | Tocilizumab + Corticosteroid Taper | 0 | Participants | ||
| Proportion of Patients Who Develop Disease Relapses | Control (Corticosteroid Taper Alone) | 10 | Participants | ||
| The Cumulative Dose of Prednisone | Tocilizumab + Corticosteroid Taper | 1,085.3 | Standard Deviation 301.3 | milligrams | |
| The Cumulative Dose of Prednisone | Control (Corticosteroid Taper Alone) | 2562.0 | Standard Deviation 1355.9 | milligrams |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tocilizumab + Corticosteroid Taper | 10 | |
| Overall Study | STARTED | Control (Corticosteroid Taper Alone) | 10 | |
| Overall Study | COMPLETED | Tocilizumab + Corticosteroid Taper | 9 | |
| Overall Study | COMPLETED | Control (Corticosteroid Taper Alone) | 10 | |
| Overall Study | NOT COMPLETED | Tocilizumab + Corticosteroid Taper | 1 | |
| Overall Study | NOT COMPLETED | Control (Corticosteroid Taper Alone) | 0 |
Source ClinicalTrials.gov
Adverse events15
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 | Neutropenia | Blood and lymphatic system disorders | Tocilizumab + Corticosteroid Taper | 1 | 10 | 7 |
| other | Viral Infection | Infections and infestations | Tocilizumab + Corticosteroid Taper | 1 | 10 | 1 |
| other | Infusion Reaction | Injury, poisoning and procedural complications | Tocilizumab + Corticosteroid Taper | 1 | 10 | 1 |
| other | Light-Headedness | General disorders | Tocilizumab + Corticosteroid Taper | 1 | 10 | 1 |
| other | Nose bleeds | Blood and lymphatic system disorders | Tocilizumab + Corticosteroid Taper | 1 | 10 | 1 |
| other | Elevated Cholesterol | Blood and lymphatic system disorders | Tocilizumab + Corticosteroid Taper | 1 | 10 | 2 |
| other | Left Rotator cuff tendinosis | Musculoskeletal and connective tissue disorders | Tocilizumab + Corticosteroid Taper | 1 | 10 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Tocilizumab + Corticosteroid Taper | 1 | 10 | 1 |
| other | Lower Back Pain | Musculoskeletal and connective tissue disorders | Tocilizumab + Corticosteroid Taper | 1 | 10 | 1 |
| other | Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Tocilizumab + Corticosteroid Taper | 2 | 10 | 3 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tocilizumab + Corticosteroid Taper | ||
| Total, other adverse events | Tocilizumab + Corticosteroid Taper | 7 | 10 |
| Total, serious adverse events | Tocilizumab + Corticosteroid Taper | 1 | 10 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tocilizumab + Corticosteroid Taper vs Control (Corticosteroid Taper Alone): Proportion of Patients in Disease Remission at Six Months From Trial Entry | Trial comparisons |
| Tocilizumab + Corticosteroid Taper vs Control (Corticosteroid Taper Alone): Proportion of Patients Who Develop Disease Relapses | 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/NCT01396317
GET https://conductscience.org/api/trials/v1/NCT01396317/registered