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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002610-12 | EudraCT Number |
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This study was designed to evaluate the efficacy and safety of secukinumab compared to placebo to maintain disease remission up to 28 weeks including corticosteroid tapering, as well as up to 1 year (52 weeks) in patients with newly diagnosed or relapsing giant cell arteritis (GCA) who were naïve to biological therapy.
This randomized, parallel-group, double-blind, placebo-controlled, multicenter, Phase II study was designed to evaluate the efficacy of secukinumab compared to placebo in combination with a 26-week prednisolone taper regimen in terms of sustained remission in patients with newly diagnosed or relapsing Giant Cell Arteritis (GCA) who were naïve to biological therapy. The study consisted of a Screening Period of up to 6 weeks (maximum duration), a 52-week Treatment Period and an 8-week Safety Follow-up Period
Patients who did not achieve remission by Week 12, experienced a flare after remission or could not adhere to the prednisolone taper regimen entered "escape". Upon entering "escape", patients received prednisolone at a dose determined by the physician's clinical judgment and continued to receive secukinumab or placebo in a blinded manner.
Safety evaluation was included in all visits including two safety follow-up visits performed 8 and 12 weeks after the last study drug administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | Experimental | Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen. |
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| Placebo | Placebo Comparator | Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab 300 mg, s.c. | Drug | Secukinumab 300 mg was administered by subcutaneous (s.c.) injections using 1 mL pre-filled syringes (PFSs) throughout the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Sustained Remission Until Week 28 | Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper regimen. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of Giant Cell Arteritis (GCA) and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or C-reactive Protein (CRP) (>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28. | Until week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Remission at Week 12 | Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or CRP (>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28. |
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Inclusion Criteria:
Diagnosis of GCA classified according to the following criteria:
Patients with new onset GCA or relapsing GCA (Definition new onset: diagnosis of GCA within 6 weeks of Baseline Visit; Definition relapsing GCA: diagnosis of GCA (in accordance with inclusion criterion no. 4) > 6 weeks before Baseline Visit and in the meantime achieved remission (absence of signs and symptoms attributable to GCA and normalization of ESR (< 30 mm/hr) and CRP (<10.0mg/L) included) including previous treatment with ≥ 25 mg/day prednisolone equivalent for ≥ 2 weeks.)
Active disease as defined by the presence of signs and symptoms of GCA (cranial or PMR) and elevated ESR ≥ 30 mm/hr, or CRP ≥ 10 mg/L, attributed to active GCA within 6 weeks of Baseline.
Prednisolone dose of 25-60 mg/day at Baseline.
Exclusion Criteria:
Previous exposure to secukinumab or other biologic drug directly targeting Interleukin(IL)-17 or IL-17 receptor.
Patients treated with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents (e.g. anti-CD3, anti-CD4, anti-CD5 or anti-CD19).
Patients who have previously been treated with any biologic agent including but not limited to tocilizumab, sirukumab, abatacept, or tumor necrosis factor alpha (TNFα) inhibitors (infliximab, adalimumab, etanercept, certolizumab, golimumab).
Patients who have previously been treated with tofacitinib or baricitinib.
Patients treated with i.v. immunoglobulins or plasmapheresis within 8 weeks prior to Baseline.
Patients treated with cyclophosphamide, tacrolimus or everolimus within 6 months prior to Baseline.
Patients treated with hydroxychloroquine, cyclosporine A, azathioprine, sulfasalazine or mycophenolate mofetil within 4 weeks of Baseline.
Patients treated with leflunomide within 8 weeks of Baseline unless a cholestyramine washout has been performed in which case the patient must be treated within 4 weeks of Baseline.
Patients treated with an alkylating agent except for cyclophosphamide as mentioned above.
Patients requiring systemic chronic glucocorticoid therapy for any other reason than GCA.
Chronic systemic glucocorticoid therapy over the last 4 years or longer; or inability, in the opinion of the investigator, to withdraw glucocorticoid therapy through protocol-defined taper regimen due to suspected or established adrenal insufficiency.
Patients requiring chronic (i.e. not occasional "prn") high potency opioid analgesics for pain management.
Active ongoing inflammatory diseases or underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, which in the opinion of the investigator immunosuppressed the patient and/or places the patient at unacceptable risk for participation in an immunomodulatory therapy.
History of renal trauma, glomerulonephritis, or patients with one kidney only, or a serum creatinine level exceeding 1.8 mg/dL (159.12 μmol/L).
Screening total white blood cell (WBC) count < 3000/μL, or platelets < 100 000/μL or neutrophils < 1500/μL or hemoglobin < 8.3 g/dL (83 g/L).
Major ischemic event, unrelated to GCA, within 12 weeks of screening.
Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening or randomization.
Life vaccinations within 6 weeks prior to Baseline or planned vaccination during study participation until 12 weeks after last study treatment administration.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Berlin | 13125 | Germany | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38251601 | Derived | Venhoff N, Schmidt WA, Bergner R, Rech J, Unger L, Tony HP, Finzel S, Andreica I, Kofler DM, Weiner SM, Lamprecht P, Schulze-Koops H, App C, Pournara E, Mendelson MH, Sieder C, Maricos M, Thiel J. Safety and efficacy of secukinumab in patients with giant cell arteritis (TitAIN): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Rheumatol. 2023 Jun;5(6):e341-e350. doi: 10.1016/S2665-9913(23)00101-7. | |
| 34404463 |
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Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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The screening period began once patients had signed the study informed consent. Screening evaluations were performed up to 6 weeks before the beginning of the Treatment period.
Participants took part in 11 investigative sites in 1 country.
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab | Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 29, 2019 | Jun 4, 2022 |
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| Prednisolone | Drug | Prednisolone was provided as tablets (1 mg, 5 mg, 10 mg, 20 mg tablets) for daily administration as tapered regimen from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 (last dose) |
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| Placebo | Drug | Placebo 300 mg was administered by subcutaneous (s.c.) injections using 1 mL pre-filled syringes (PFSs) throughout the study. |
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| Week 12 |
| Time to First GCA Flare After Clinical Remission | Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or CRP (>/=10.0 mg/L) attributable to GCA. Time to first flare after remission referred to time from first day of study treatment until first post-Baseline flare. For time to first GCA flare after remission (up to and including Week 52), patients who prematurely discontinued study treatment prior to Week 52 were censored at the time of premature discontinuation and patients who completed treatment and did not have a flare were censored at their last visit in the treatment phase. Time to first GCA flare after remission was calculated using Kaplan-Meier plot of time. | Up to Week 52 (included) |
| Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks | Total cumulative co-administered prednisolone treatment was summarized over time by treatment arm. Patients received a daily dose of prednisolone, which was decreased (i.e. tapered down) from Baseline to Week 26. No additional prednisolone or equivalent was permitted. | from Baseline to week 28, from baseline to week 52 weeks |
| Percentage of Participants With GCA Who Had Sustained Remission Until Week 52 | Remission was defined as the absence of flare. Sustained remission was defined as patients without flare until Week 52 and in adherence to the protocol prednisolone taper regimen plus prednisolone-free phase from Week 27 onwards. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or CRP (>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28. | Until Week 52 |
| Number of Participants on Prednisolone Dose ≤ 5mg/Day | Number of participants on co-administered prednisolone treatment ≤ 5mg/day who responded at Week 19, Week 26 and Week 52. Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. There were 2 taper regimens: for patients on 40 to 60 mg/day prednisolone at Baseline and for patients on 25 to 40 mg/day prednisolone at Baseline depending on patients' prednisolone levels at Baseline. Prednisolone was tapered from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 [last dose]. | Week 19, Week 28, Week 52 |
| Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Clinician Reported Outcome: Physicians global assessment (PhGA) using a visual analogue scale (VAS) scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 |
| Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Patient Reported Outcome: Patients global assessment (PGA) score using a VAS scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 |
| Change From Baseline in FACIT-Fatigue Scale | Patient Reported Outcome: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item questionnaire with a full scale of 0 -52 that assesses self-reported fatigue and its impact upon daily activities and function. The higher the score the better functioning (less fatigue). | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 |
| Change From Baseline in Short-Form (SF)-36 Questionnaire | Patient Reported Outcome: The SF-36 is a standardized questionnaire used to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of 8 subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The higher the score (change from baseline) the more favorable the outcome. The values were reported by change from baseline in SF-36 domain scores. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 |
| Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L, a self-administered questionnaire assessing health status in adults, is divided into 2 sections. The 1st section addresses 5 dimensions (mobility, self-care, usual activity, pain/discomfort, & anxiety/depression). Items are rated either "no problem", "slight problems", "moderate problems", "severe problems", or "extreme problems/unable." A composite health index is defined by combining the levels for each dimension. The 2nd section measures self-rated (global) health status via vertically oriented VAS where 100 represents the "best possible health state" & 0 represents the "worst possible health state." The EQ-5D-5L contains 6 items assessing health status via a single index value or health utility score and allows "weighting" by the patient of health states & generation of patient utilities. Published weights are available allowing for creation of a single summary health utility score. Scores range from 0 to 1, with lower scores representing a higher level of dysfunction. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | ESR is a laboratory test that provides a non-specific measure of inflammation. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. | Baseline, Week 28, Week 52 |
| Change From Baseline in C-Reactive Protein (CRP) Level | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | Baseline, Week 28, Week 52 |
| Cologne |
| 50937 |
| Germany |
| Novartis Investigative Site | Dresden | 01067 | Germany |
| Novartis Investigative Site | Erlangen | 91054 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Germering | 82110 | Germany |
| Novartis Investigative Site | Herne | 44649 | Germany |
| Novartis Investigative Site | Ludwigshafen | 67063 | Germany |
| Novartis Investigative Site | Lübeck | 23538 | Germany |
| Novartis Investigative Site | Trier | 54292 | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
| Derived |
| Venhoff N, Schmidt WA, Lamprecht P, Tony HP, App C, Sieder C, Legeler C, Jentzsch C, Thiel J. Efficacy and safety of secukinumab in patients with giant cell arteritis: study protocol for a randomized, parallel group, double-blind, placebo-controlled phase II trial. Trials. 2021 Aug 17;22(1):543. doi: 10.1186/s13063-021-05520-1. |
| A Plain Language Trial Summary is available on novctrd.com | View source |
Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen. |
| COMPLETED |
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| NOT COMPLETED |
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The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab | Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen. |
| BG001 | Placebo | Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants in Sustained Remission Until Week 28 | Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper regimen. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of Giant Cell Arteritis (GCA) and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or C-reactive Protein (CRP) (>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28. | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). | Posted | Count of Participants | Participants | Until week 28 |
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| Secondary | Percentage of Participants in Remission at Week 12 | Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or CRP (>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28. | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Time to First GCA Flare After Clinical Remission | Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or CRP (>/=10.0 mg/L) attributable to GCA. Time to first flare after remission referred to time from first day of study treatment until first post-Baseline flare. For time to first GCA flare after remission (up to and including Week 52), patients who prematurely discontinued study treatment prior to Week 52 were censored at the time of premature discontinuation and patients who completed treatment and did not have a flare were censored at their last visit in the treatment phase. Time to first GCA flare after remission was calculated using Kaplan-Meier plot of time. | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). | Posted | Median | 95% Confidence Interval | days | Up to Week 52 (included) |
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| Secondary | Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks | Total cumulative co-administered prednisolone treatment was summarized over time by treatment arm. Patients received a daily dose of prednisolone, which was decreased (i.e. tapered down) from Baseline to Week 26. No additional prednisolone or equivalent was permitted. | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). | Posted | Mean | Standard Deviation | milligrams | from Baseline to week 28, from baseline to week 52 weeks |
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| Secondary | Percentage of Participants With GCA Who Had Sustained Remission Until Week 52 | Remission was defined as the absence of flare. Sustained remission was defined as patients without flare until Week 52 and in adherence to the protocol prednisolone taper regimen plus prednisolone-free phase from Week 27 onwards. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or CRP (>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28. | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). | Posted | Count of Participants | Participants | Until Week 52 |
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| Secondary | Number of Participants on Prednisolone Dose ≤ 5mg/Day | Number of participants on co-administered prednisolone treatment ≤ 5mg/day who responded at Week 19, Week 26 and Week 52. Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. There were 2 taper regimens: for patients on 40 to 60 mg/day prednisolone at Baseline and for patients on 25 to 40 mg/day prednisolone at Baseline depending on patients' prednisolone levels at Baseline. Prednisolone was tapered from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 [last dose]. | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). n represents the number of participants with a value for a specific categorical variable at Week 19, 28 and 52. | Posted | Count of Participants | Participants | Week 19, Week 28, Week 52 |
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| Secondary | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Clinician Reported Outcome: Physicians global assessment (PhGA) using a visual analogue scale (VAS) scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity. | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 |
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| Secondary | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Patient Reported Outcome: Patients global assessment (PGA) score using a VAS scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity. | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 |
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| Secondary | Change From Baseline in FACIT-Fatigue Scale | Patient Reported Outcome: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item questionnaire with a full scale of 0 -52 that assesses self-reported fatigue and its impact upon daily activities and function. The higher the score the better functioning (less fatigue). | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 |
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| Secondary | Change From Baseline in Short-Form (SF)-36 Questionnaire | Patient Reported Outcome: The SF-36 is a standardized questionnaire used to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of 8 subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The higher the score (change from baseline) the more favorable the outcome. The values were reported by change from baseline in SF-36 domain scores. | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 |
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| Secondary | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L, a self-administered questionnaire assessing health status in adults, is divided into 2 sections. The 1st section addresses 5 dimensions (mobility, self-care, usual activity, pain/discomfort, & anxiety/depression). Items are rated either "no problem", "slight problems", "moderate problems", "severe problems", or "extreme problems/unable." A composite health index is defined by combining the levels for each dimension. The 2nd section measures self-rated (global) health status via vertically oriented VAS where 100 represents the "best possible health state" & 0 represents the "worst possible health state." The EQ-5D-5L contains 6 items assessing health status via a single index value or health utility score and allows "weighting" by the patient of health states & generation of patient utilities. Published weights are available allowing for creation of a single summary health utility score. Scores range from 0 to 1, with lower scores representing a higher level of dysfunction. | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 |
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| Secondary | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | ESR is a laboratory test that provides a non-specific measure of inflammation. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from Baseline at each visit is calculated only for subjects with a value at Baseline and the particular visit. | Posted | Mean | Standard Deviation | mm/hr | Baseline, Week 28, Week 52 |
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| Secondary | Change From Baseline in C-Reactive Protein (CRP) Level | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from Baseline at each visit is calculated only for subjects with a value at Baseline and the particular visit. | Posted | Mean | Standard Deviation | mg/L | Baseline, Week 28, Week 52 |
|
Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo.
Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Secukinumab | Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen. | 1 | 27 | 6 | 27 | 25 | 27 |
| EG001 | Placebo | Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen. | 1 | 25 | 11 | 25 | 23 | 25 |
| EG002 | All Participants | All participants who participated in the study. | 2 | 52 | 17 | 52 | 48 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Noninfective sialoadenitis | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Inflammatory marker increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cushingoid | Endocrine disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Giant cell arteritis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e. data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2021 | Jun 4, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen. |
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| Participants |
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| Placebo |
Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen. |
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| Participants |
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| Participants |
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| OG001 | Placebo | Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen. |
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|---|---|
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| Participants |
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