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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001516-26 | EudraCT Number |
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The purpose of this study was to investigate the efficacy and safety of secukinumab subcutaneously (s.c.) compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy.
This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase IIIb, 24-week study to investigate the superior efficacy of secukinumab and safety in participants with rotator cuff tendinopathy.
Secukinumab 300 mg s.c. was compared to placebo (both arms in combination with patient individualized conventional therapy) in relieving clinical symptoms at Week 24.
The study consisted of a screening period up to 6 weeks, a 2-week run-in period, a 12-week treatment period and a 12-week follow-up period. Treatment and follow-up periods were blinded. Participants who met the eligibility criteria at screening continued to the run-in period and were randomized. In the run-in period, participants performed 2 weeks of home-based standardized physiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | Experimental | Participants received 300 mg of secukinumab s.c. for 12 weeks |
|
| Placebo | Placebo Comparator | Participants received placebo s.c. for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug | Secukinumab 300 mg s.c for 12 weeks in a pre-filled syringe (PFS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Percentage Score at Week 24 | The WORC Index consisted of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). Each of the 21 items in the WORC was rated using a visual analogue scale (VAS) ranging from 0 (no impact on quality of life) to 100 (worst possible impact). Thus, the total score ranged from 0 to 2100 points. The score was reported as a percentage of normal by subtracting the total score from 2100, dividing by 2100, and multiplying by 100. Total final WORC percentage scores ranged from 0%, the lowest functional status level, to 100%, the highest functional status level. Change from baseline in the WORC percentage total score was assessed at Week 24. A positive change from baseline indicated an improvement. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the WORC Percentage Sub-scores at Week 24 | The WORC Index consisted of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). Each of the 21 items in the WORC was rated using a VAS ranging from 0 (no impact on quality of life) to 100 (worst possible impact). Each subdomain score was calculated as a percentage of normal function, ranging from 0% (worst condition) to 100% (best condition). Change from baseline in the WORC Index percentage sub-domain score was assessed at Week 24. A positive change from baseline indicated an improvement |
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Inclusion Criteria:
Signed informed consent had to be obtained prior to participation in the study.
Males and non-pregnant, non-nursing females were between 18 and 65 years of age.
Rotator cuff tendinopathy (unilateral) was present with a positive "Painful Arc Test" on examination.
Symptoms had been present for at least 6 weeks but not more than 6 months at Baseline.
Moderate to severe rotator cuff tendinopathy was demonstrated by all of the following criteria:
Patients had failed at least 8 weeks of conventional therapy prior to Baseline: inadequate response to NSAIDs and/or paracetamol and physiotherapy; or intolerance to NSAIDs and/or paracetamol.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Karlsruhe | Baden-Wurttemberg | 76133 | Germany | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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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A total of 100 participants were screened and 62 participants were randomized in nearly equal numbers to the 2 treatment groups (secukinumab: N=30; placebo: N=32) and received study treatment
Patients were randomized in 19 study sites across Germany
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab | Participants received 300 mg of secukinumab s.c. for 12 weeks |
| FG001 | Placebo | Participants received placebo s.c. for 12 weeks |
| 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 | Jul 10, 2024 | Nov 7, 2025 |
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Parallel Assignment
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| Placebo | Other | Placebo to match secukinumab s.c. for 12 weeks in a PFS |
|
| Baseline, Week 24 |
| Change From Baseline in Participant's Global Assessment of Disease Activity Score at Week 24 | The participant's global assessment of disease activity was performed using 100 mm VAS ranging from 0="no activity" to 100= "most active", after the question " Please indicate with a vertical mark ( | ) through the horizontal line the global activity of your disease in the last 24 hours". Change from baseline in the participant's global assessment of disease activity score was assessed at Week 24. A negative change from baseline indicated improvement | Baseline, Week 24 |
| Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24 | The SF-36 Health Survey was a validated questionnaire assessing health-related quality of life. Participants completed the survey throughout the study, reflecting their health status over the previous 4 weeks. It consisted of eight subscales that were scored individually; and two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Component summary scores (PCS and MCS) were derived from weighted combinations of the eight subscales. Each domain and component summary score ranged from 0 to 100, with higher scores indicating better quality of life. Change from baseline to Week 24 in all subscale and summary scores was assessed, where a positive change indicated improvement. | Baseline, Week 24 |
| Change From Baseline in Quick Disability of the Arm, Shoulder and Hand (DASH) Questionnaire Score at Week 24 | The QuickDASH was an abbreviated form of the DASH. The QuickDASH Index was self-administered and used 11 items to measure physical function and symptoms in participants with any or multiple musculoskeletal disorders of the upper limb. It had a recall period of 1 week. Each item of the QuickDASH had five response options. The raw score was calculated as the sum of responses, converted to an average, and rescaled to a total score ranging from 0 (no disability) to 100 (most severe disability) Change from baseline to Week 24 was assessed. A negative change from baseline indicated improvement. | Baseline, Week 24 |
| Change From Baseline in the Numeric Rating Scale (NRS) Pain Score at Week 24 | The score for pain was assessed by using an 11-point NRS ranging from 0 "no pain at all" to 10 "worst possible pain", after the question "On a numeric scale of 0-10 where would you rate your pain at this time". Change from baseline to Wek 24 was assessed. A negative change from baseline indicated improvement | Baseline, Week 24 |
| Change From Baseline in EuroQol 5 Dimensions- 5 Levels (EQ-5D-5L) at Week 24- Total Score | The EQ-5D-5L was a standardized instrument used to evaluate patients' overall health-related quality of life (QoL). It consisted of two components: the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system assessed five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension was rated on five levels, from 1 (no problems) to 5 (extreme problems). These ratings were combined to generate a composite health index, which could be converted into a single summary health utility score using published value sets. Total scores ranged from 0 to 1, with lower scores indicating greater health impairment. Changes in total scores from baseline to Week 24 were analyzed, with positive changes indicating improvement in health-related quality of life. | Baseline, Week 24 |
| Change From Baseline in EuroQol 5 Dimensions- 5 Levels (EQ-5D-5L) at Week 24- EQ VAS | The EQ-5D-5L was a standardized instrument used to evaluate patients' overall health-related quality of life (QoL). It consisted of two components: the descriptive system and the EQ visual analogue scale (EQ VAS). The EQ VAS captured the respondent's self-rated health on a vertical scale ranging from 0 (worst imaginable health) to 100 (best imaginable health). Changes in EQ VAS scores from baseline to Week 24 were analyzed, with positive changes indicating improvement in health-related quality of life. | Baseline, Week 24 |
| Munich |
| Bavaria |
| 80809 |
| Germany |
| Novartis Investigative Site | Hanover | Lower Saxony | 30159 | Germany |
| Novartis Investigative Site | Halle | Saxony-Anhalt | 06120 | Germany |
| Novartis Investigative Site | Bad Doberan | 18209 | Germany |
| Novartis Investigative Site | Berlin | 10787 | Germany |
| Novartis Investigative Site | Berlin | 12627 | Germany |
| Novartis Investigative Site | Cottbus | 03042 | Germany |
| Novartis Investigative Site | Dresden | 01069 | Germany |
| Novartis Investigative Site | Erlangen | 91054 | Germany |
| Novartis Investigative Site | Frankfurt am Main | 60313 | Germany |
| Novartis Investigative Site | Gladbeck | 45968 | Germany |
| Novartis Investigative Site | Hamburg | 20095 | Germany |
| Novartis Investigative Site | Hamburg | 20149 | Germany |
| Novartis Investigative Site | Hamburg | 22415 | Germany |
| Novartis Investigative Site | Heinsberg | 52525 | Germany |
| Novartis Investigative Site | Herne | 44649 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Schönebeck | 39218 | Germany |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab | Participants received 300 mg of secukinumab s.c. for 12 weeks |
| BG001 | Placebo | Participants received placebo s.c. for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Percentage Score at Week 24 | The WORC Index consisted of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). Each of the 21 items in the WORC was rated using a visual analogue scale (VAS) ranging from 0 (no impact on quality of life) to 100 (worst possible impact). Thus, the total score ranged from 0 to 2100 points. The score was reported as a percentage of normal by subtracting the total score from 2100, dividing by 2100, and multiplying by 100. Total final WORC percentage scores ranged from 0%, the lowest functional status level, to 100%, the highest functional status level. Change from baseline in the WORC percentage total score was assessed at Week 24. A positive change from baseline indicated an improvement. | FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 24 |
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| Secondary | Change From Baseline in the WORC Percentage Sub-scores at Week 24 | The WORC Index consisted of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). Each of the 21 items in the WORC was rated using a VAS ranging from 0 (no impact on quality of life) to 100 (worst possible impact). Each subdomain score was calculated as a percentage of normal function, ranging from 0% (worst condition) to 100% (best condition). Change from baseline in the WORC Index percentage sub-domain score was assessed at Week 24. A positive change from baseline indicated an improvement | FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 24 |
|
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| Secondary | Change From Baseline in Participant's Global Assessment of Disease Activity Score at Week 24 | The participant's global assessment of disease activity was performed using 100 mm VAS ranging from 0="no activity" to 100= "most active", after the question " Please indicate with a vertical mark ( | ) through the horizontal line the global activity of your disease in the last 24 hours". Change from baseline in the participant's global assessment of disease activity score was assessed at Week 24. A negative change from baseline indicated improvement | FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24 | The SF-36 Health Survey was a validated questionnaire assessing health-related quality of life. Participants completed the survey throughout the study, reflecting their health status over the previous 4 weeks. It consisted of eight subscales that were scored individually; and two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Component summary scores (PCS and MCS) were derived from weighted combinations of the eight subscales. Each domain and component summary score ranged from 0 to 100, with higher scores indicating better quality of life. Change from baseline to Week 24 in all subscale and summary scores was assessed, where a positive change indicated improvement. | FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Quick Disability of the Arm, Shoulder and Hand (DASH) Questionnaire Score at Week 24 | The QuickDASH was an abbreviated form of the DASH. The QuickDASH Index was self-administered and used 11 items to measure physical function and symptoms in participants with any or multiple musculoskeletal disorders of the upper limb. It had a recall period of 1 week. Each item of the QuickDASH had five response options. The raw score was calculated as the sum of responses, converted to an average, and rescaled to a total score ranging from 0 (no disability) to 100 (most severe disability) Change from baseline to Week 24 was assessed. A negative change from baseline indicated improvement. | FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Numeric Rating Scale (NRS) Pain Score at Week 24 | The score for pain was assessed by using an 11-point NRS ranging from 0 "no pain at all" to 10 "worst possible pain", after the question "On a numeric scale of 0-10 where would you rate your pain at this time". Change from baseline to Wek 24 was assessed. A negative change from baseline indicated improvement | FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EuroQol 5 Dimensions- 5 Levels (EQ-5D-5L) at Week 24- Total Score | The EQ-5D-5L was a standardized instrument used to evaluate patients' overall health-related quality of life (QoL). It consisted of two components: the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system assessed five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension was rated on five levels, from 1 (no problems) to 5 (extreme problems). These ratings were combined to generate a composite health index, which could be converted into a single summary health utility score using published value sets. Total scores ranged from 0 to 1, with lower scores indicating greater health impairment. Changes in total scores from baseline to Week 24 were analyzed, with positive changes indicating improvement in health-related quality of life. | FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EuroQol 5 Dimensions- 5 Levels (EQ-5D-5L) at Week 24- EQ VAS | The EQ-5D-5L was a standardized instrument used to evaluate patients' overall health-related quality of life (QoL). It consisted of two components: the descriptive system and the EQ visual analogue scale (EQ VAS). The EQ VAS captured the respondent's self-rated health on a vertical scale ranging from 0 (worst imaginable health) to 100 (best imaginable health). Changes in EQ VAS scores from baseline to Week 24 were analyzed, with positive changes indicating improvement in health-related quality of life. | FAS: all patients to whom study/reference treatment was assigned by randomization. Only participants with both a baseline and a Week 24 assessment were included in the analysis. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 24 |
|
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From start of treatment to end of study, assessed up to approximately 24 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Secukinumab | AEs from start of treatment to 84 days after the last dose of study treatment, assessed up to approximately 24 weeks | 0 | 30 | 2 | 30 | 22 | 30 |
| EG001 | Placebo | AEs from start of treatment to 84 days after the last dose of study treatment, assessed up to approximately 24 weeks | 0 | 32 | 3 | 32 | 24 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oropharyngeal candidiasis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Vaginal cuff dehiscence | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Pancreatic neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Systematic Assessment |
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| Occipital lobe stroke | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
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| Paradoxical embolism | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Fatigue | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
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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 the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | +1 862 778 8300 | novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2025 | Nov 7, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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