A randomized, double-blind, placebo-controlled, parallel group, Phase II, 24-week study investigating the efficacy, safety and tolerability of AIN457 in patients with active overuse tendinopathy refractory to oral NSAIDs/acetaminophen, physiotherapy or corticosteroid injections

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

Patients eligible for inclusion in this study must fulfill all of the following criteria:
* Written informed consent obtained prior to all study specific screening procedures, as close to the start of the screening period as possible
* Male or non-pregnant, non-lactating female patients 18 to 65 years of age at randomization
* Presence of unilateral rotator cuff tendinopathy with:
a. Symptoms present *6 weeks, but <12 months prior to randomization
b. Tendinopathy with no more than a 50% tear as established by ultrasound at screening 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
c. 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
d. 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 defined as:
- NSAIDs / acetaminophen
- In the run-in period patients should be on a stable dose of NSAIDs and/or acetaminophen for at least 2 weeks prior to randomization, not exceeding * e.g.: Ibuprofen 1600 mg/d, naproxen 1000 mg, diclofenac 105 mg/d, or diclofenac sodium enteric-coated tablets 150 mg/d, or equivalent.
- If patients cannot tolerate these doses, the maximal tolerable dose should be used, and may be augmented with acetaminophen/paracetamol, at doses not exceed local guidelines or 4 g/day, whichever is lower. This medication should also be at a stable dose for at least 2 weeks.
- If patients have contraindications to NSAIDs or to acetaminophen, these treatments can be omitted (contraindication, drug and dose must be specified in the eCRF).
- If patients were refractory to at least 2 weeks of previous treatment as specified in 4 i/ii, NSAIDs or acetaminophen treatment can be omitted.
* Physiotherapy
- In the run in period patients should have had 2 weeks of a standardized physiotherapy treatment before randomization

Exclusion Criteria

* History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes
* Rheumatologic, inflammatory diseases, including but not limited to: PsA, AS and RA
* Previous shoulder surgery in affected shoulder
* 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
* 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
* Neck conditions, including but not limited to cervical spine syndrome, which in the opinion of the investigator, may explain the patient*s symptoms
* Previous platelet rich plasma injections within the last 12 months prior to randomization