Trial · NCT01364389
A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
NCT01364389, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2015-03-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica. Trials, record NCT01364389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01364389
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
- NCT number
- NCT01364389
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Polymyalgia Rheumatica, Inflammatory Diseases
- Interventions
- AIN457, ACZ885, Prednisone, Placebo
- First posted
- 2011-06-02
- Last updated
- 2021-09-17
- Other registries' IDs
- eudract:2010-019395-73
- Results first posted
- 2015-03-04
- Limitations and caveats
- This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Polymyalgia Rheumatica Activity Score (PMR-AS) | Baseline, Day 15 | The efficacy of a single dose of AIN457 and ACZ885 (canakinumab) was measured by the polymyalgia rheumatica activity score. A composite PMR-AS was developed from the following components: measure of C-reactive protein (CRP), measure of Erythrocyte Sedimentation Rate (ESR), assessment of early morning stiffness, assessment of the patient's elevation on upper limbs, patient's assessment of pain, and physician's global assessment of disease activity. Treatment effect was measured by the percent reduction in PMR-AS. N=3 for the ACZ885 arm because CRP values at Day 15 were missing for 2 participants. |
| Secondary | Time to Partial Clinical Response | Day 15 | The time to partial clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a partial clinical response at Day 15. A participant was defined as a partial responder if the participant had: \>50% reduction in patient global assessment visual analogue scale (VAS) compared with baseline and morning stiffness \< 60 minutes. |
| Secondary | Time to Complete Clinical Response | Day 15 | The time to complete clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a complete clinical response at Day 15. A participant was defined as a complete responder if the participant had: \>70% reduction in patient global assessment VAS compared with baseline, morning stiffness \< 30 min, CRP \< 1.0 mg/dL and/or ESR \< 30 mm/1st hr. |
| Secondary | Time to First Flare | 6 months | This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. Only 1 participant experienced a flare, in the AIN457 treatment group. The flare for this one participant occurred on study day 44 |
| Secondary | Number of Flares Over a 6 Month Period | 6 months | This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure. |
| Secondary | Mean Steroid Dose Over a 6 Month Period | 6 months | This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure. |
| Secondary | Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths | 6 months | |
| Secondary | Comparison Between the Initial Response to AIN457 and ACZ885 and the Response After Re-dosing of AIN457 and ACZ885 - Assessed by the Number of Flares After Redosing. | 6 months | One participant experienced one flare after initial dose but this participant had no flare after a redose. This patient was in the AIN457 arm. |
| Secondary | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | 6 months | The Short Form-36 (SF-36) Questionnaire is a 36-item questionnaire yields an 8-scale health profile as well as summary measures of individual patients.. The scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with higher scores indicative of better health. |
| Secondary | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) | baseline and at month 6 | HAQ: The scores range from 0 (min) to 3 (max). Higher scores = more disability; lower scores = less disability. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Polymyalgia Rheumatica Activity Score (PMR-AS) | Baseline, Day 15 | Pharmacodynamic (PD) Analysis Set: This set included participants who received at least one dose of study medication and had no major protocol deviation that may impact the PD data. | Percent reduction | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Partial Clinical Response | Day 15 | PD analysis set | Percentage of participants | NUMBER |
| SECONDARY | Time to Complete Clinical Response | Day 15 | PD analysis set | Percentage of participants | NUMBER |
| SECONDARY | Time to First Flare | 6 months | This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. Only 1 participant experienced a flare, in the AIN457 treatment group. The flare for this one participant occurred on study day 44 | Days | NUMBER |
| SECONDARY | Number of Flares Over a 6 Month Period | 6 months | This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure. | Participant | NUMBER |
| SECONDARY | Mean Steroid Dose Over a 6 Month Period | 6 months | This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure. | Number of doses | MEAN |
| SECONDARY | Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths | 6 months | Safety analysis set: This set included all participants who received at least one dose of study medication. | Participants | NUMBER |
| SECONDARY | Comparison Between the Initial Response to AIN457 and ACZ885 and the Response After Re-dosing of AIN457 and ACZ885 - Assessed by the Number of Flares After Redosing. | 6 months | One participant experienced one flare after initial dose but this participant had no flare after a redose. This patient was in the AIN457 arm. | ||
| SECONDARY | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | 6 months | This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure. | Scores on a scale | MEAN |
| SECONDARY | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) | baseline and at month 6 | This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure. | Scores on a scale | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Polymyalgia Rheumatica Activity Score (PMR-AS) | ACZ885 | 64.5 | Standard Error 0.68 | Percent reduction | |
| Polymyalgia Rheumatica Activity Score (PMR-AS) | AIN457 | 51.7 | Standard Error 0.47 | Percent reduction | |
| Polymyalgia Rheumatica Activity Score (PMR-AS) | Prednisone | 91.9 | Standard Error 86.2 | Percent reduction | |
| Time to Partial Clinical Response | ACZ885 | 20.0 | Percentage of participants | ||
| Time to Partial Clinical Response | AIN457 | 16.7 | Percentage of participants | ||
| Time to Partial Clinical Response | Prednisone | 75.0 | Percentage of participants | ||
| Time to Complete Clinical Response | ACZ885 | 0.0 | Percentage of participants | ||
| Time to Complete Clinical Response | AIN457 | 0.0 | Percentage of participants | ||
| Time to Complete Clinical Response | Prednisone | 25.0 | Percentage of participants | ||
| Time to First Flare | AIN457 | 44 | Days |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ACZ885 | 5 | |
| Overall Study | STARTED | AIN457 | 6 | |
| Overall Study | STARTED | Prednisone | 5 | |
| Overall Study | Pharmacodynamic (PD) Analysis Set | ACZ885 | 5 | |
| Overall Study | Pharmacodynamic (PD) Analysis Set | AIN457 | 6 | |
| Overall Study | Pharmacodynamic (PD) Analysis Set | Prednisone | 4 | |
| Overall Study | COMPLETED | ACZ885 | 3 | |
| Overall Study | COMPLETED | AIN457 | 5 | |
| Overall Study | COMPLETED | Prednisone | 4 | |
| Overall Study | NOT COMPLETED | ACZ885 | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse 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 | Vertigo | Ear and labyrinth disorders | ACZ885 3mg/kg | 0 | 5 | |
| other | Vertigo | Ear and labyrinth disorders | AIN457 3mg/kg | 0 | 6 | |
| other | Vertigo | Ear and labyrinth disorders | Prednisone 20mg | 1 | 5 | |
| other | Eye pain | Eye disorders | ACZ885 3mg/kg | 0 | 5 | |
| other | Eye pain | Eye disorders | AIN457 3mg/kg | 1 | 6 | |
| other | Eye pain | Eye disorders | Prednisone 20mg | 0 | 5 | |
| other | Abdominal pain upper | Gastrointestinal disorders | ACZ885 3mg/kg | 0 | 5 | |
| other | Abdominal pain upper | Gastrointestinal disorders | AIN457 3mg/kg | 0 | 6 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Prednisone 20mg | 1 | 5 | |
| other | Dyspepsia | Gastrointestinal disorders | ACZ885 3mg/kg | 0 | 5 |
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 | ACZ885 3mg/kg | 0 | 5 |
| Total, all-cause mortality | AIN457 3mg/kg | 0 | 6 |
| Total, all-cause mortality | Prednisone 20mg | 0 | 5 |
| Total, other adverse events | ACZ885 3mg/kg | 3 | 5 |
| Total, other adverse events | AIN457 3mg/kg | 2 | 6 |
| Total, other adverse events | Prednisone 20mg | 5 | 5 |
| Total, serious adverse events | ACZ885 3mg/kg | 0 | 5 |
| Total, serious adverse events | AIN457 3mg/kg | 0 | 6 |
| Total, serious adverse events | Prednisone 20mg | 0 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39400109 | DERIVED |
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.
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