Trial · NCT05767034
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
NCT05767034, Phase 3, Completed, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR). Trials, record NCT05767034. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05767034
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
- NCT number
- NCT05767034
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 381 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Polymyalgia Rheumatica
- Interventions
- Secukinumab 300 mg, Secukinumab 150 mg, Placebo to secukinumab
- First posted
- 2023-03-14
- Last updated
- 2026-06-22
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 participants achieving sustained remission | at Week 52 | Sustained remission at Week 52 is defined as a participant meeting all of the following: ● achieved remission at Week 12 AND all of the following, sustained from Week 12 to Week 52: * no recurrence of signs or symptoms, attributable to PMR, that requires escape treatment or rescue treatment * no new diagnosis of Giant cell arteritis (GCA), that requires escape treatment or rescue treatment Remission at Week 12 is defined as a participant meeting all of the following at Week 12: * no use of escape treatment or rescue treatment prior to Week 12 * no signs or symptoms attributable to PMR, that requires escape treatment or use of rescue treatment, at Week 12 * no new diagnosis of GCA, that requires escape treatment or rescue treatment, at Week 12 |
| Secondary | Proportion of patients achieving complete sustained remission | 52 Weeks | Complete sustained remission at Week 52 is defined as participant meeting all of the following: * achieved sustained remission * no clinically relevant elevation of Erythrocyte sedimentation Rate (ESR) and/or C-reactive protein (CRP) at ≥2 consecutive scheduled visits from Week 12 to Week 52 |
| Secondary | Adjusted annual cumulative glucocorticoid (GC) dose adjusted by duration of study follow-up | 52 Weeks | Adjusted annual cumulative GC dose is cumulative GC dose through Week 52 adjusted by duration of study follow-up |
| Secondary | Time to first use of escape treatment or rescue treatment as measured in days | 52 Weeks | First use of escape treatment or rescue treatment is defined as the first time when the escape treatment or rescue treatment is used |
| Secondary | Change in FACIT-Fatigue Score | 52 Weeks | The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. The purpose of collecting available FACIT-Fatigue data is to assess the impact of fatigue on participants with PMR. |
| Secondary | Change in HAQ-DI score | 52 Weeks | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is used to assess the long-term influence of chronic disease on a participant's level of functional ability and activity restriction. The purpose of the HAQ-DI is to assess the functional ability of subjects with PMR. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT05767034
GET https://conductscience.org/api/trials/v1/NCT05767034/registered