Status:
COMPLETED
Study of Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Tendinopathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This was a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c. secukinumab 300 mg in 98 randomized patients with overuse rotator-cuff tendinopathy without systemic infla...
Detailed Description
This was a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c. secukinumab 300 mg in 98 randomized patients with overuse rotator-cuff tendinopathy without systemic infla...
Eligibility Criteria
Inclusion
- Male or non-pregnant, non-lactating female patients 18 to 65 years of age at randomization
- Presence of unilateral rotator cuff tendinopathy with:
- Symptoms present ≥6 weeks, but \<12 months prior to randomization
- Tendinopathy with no more than a 50% tear as established by ultrasound at screening (historic data acceptable if not older than 3 months) and MRI at baseline: Sein MRI tendinopathy scoring system grade I-III; with no tear or partial tear \[maximum 50% tendon thickness (Bauer tendon thickness score maximum 2); AP length maximum 10 mm (Bauer tendon length score max 2)\]. Maximum 50% of patients with partial tear
- Pain in the affected shoulder (at rest or on movement) on at least 3 days out of 7 days in the past week prior to baseline and a score of ≥4 out of 10 on a VAS pain scale
- Positive "Painful Arc Test" on examination and/or nightly pain in the affected shoulder on at least 4 out of 7 days in the past week prior to baseline
- The rotator-cuff tendinopathy must have been refractory to standard treatment, including NSAIDs and physiotherapy
Exclusion
- 1\. Rheumatologic, inflammatory diseases, including but not limited to: PsA, AS and RA 2. Previous shoulder surgery in affected shoulder 3. History of adhesive capsulitis/frozen shoulder or calcification in the tendon (in affected or contralateral shoulder) confirmed by X-Ray, historic X-Rays can be used if performed within 3 months of baseline 4. Symptomatic osteoarthritis of the shoulder (gleno-humeral, acromioclavicular) (in affected or contralateral shoulder confirmed by X-Ray, historic X-Rays can be used if performed within 3 months of baseline 5. Neck conditions, including but not limited to cervical spine syndrome, which in the opinion of the investigator, may explain the patient's symptoms 6. Previous platelet rich plasma injections within the last 12 months prior to randomization 7. Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents (e.g. Campath, anti-CD4, anti-CD5, anti-CD3, anti-CD19) 8. Previous exposure to any biologic immunomodulating agents, including but not limited to TNFalpha inhibitors (including, but not limited to adalimumab, infliximab), or biologics targeting IL-17 (including, but not limited to secukinumab, ixekizumab or brodalumab) or the IL-17 receptor within the last 12 months prior to baseline 9. Any intraarticular/subacromial corticosteroid treatment within 8 weeks prior to randomization and more than 3 injections for the current tendinopathy. Oral, intramuscular or i.v. corticosteroid treatment within the last 12 months prior to randomization
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Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2019
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03344640
Start Date
December 15 2017
End Date
October 17 2019
Last Update
October 8 2021
Active Locations (12)
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1
Novartis Investigative Site
Phoenix, Arizona, United States, 85053
2
Novartis Investigative Site
La Mesa, California, United States, 91942
3
Novartis Investigative Site
Clearwater, Florida, United States, 33765
4
Novartis Investigative Site
Miami Lakes, Florida, United States, 33014