To assess the efficacy of secukinumab 300 mg s .c. vs. placebo in patients with overuse rotator cuff tendinopathy in relieving clinical symptoms at week 14
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Western Ontario Rotator Cuff (WORC) patient reported outcome (PRO) score at
week 14
Secondary outcome
* WORC score at Weeks 2, 4, 8, 12, 18 and 24
* Disability of Arm, Shoulder and Hand Questionnaire (QuickDASH) score at Weeks
2, 4, 8, 12, 14, 18 and 24
* American Shoulder and Elbow Surgeons Shoulder Evaluation Form (ASES) score at
Weeks 2, 4, 8, 12, 14, 18 and 24
* EQ5D-3L score at Weeks 2, 4, 8, 12, 14, 18 and 24
* Pain score using a VAS scale (considering the last 24 hours) at Weeks 2, 4,
8, 12, 14, 18 and 24
* Patient global assessment (PGA) score using a VAS scale (considering the last
24 hours), at Weeks 2, 4, 8, 12, 14, 18 and 24
* Physician global assessment (PhGA) score using a VAS scale (considering the
last 24 hours), at Weeks 2, 4, 8, 12, 14, 18 and 24
* MRI Sein score at Weeks 8, 14 and 24
* PK/immunogenicity assessment at Day 1, Weeks 4, 12, 24
* Safety and tolerability assessments over time: Incidence and severity of AEs
and SAEs; routine safety laboratory parameters
Background summary
Overuse tendinopathy is a complex multi-faceted disease of the tendon,
clinically diagnosed after gradual onset of activity-related pain, decreased
function and sometimes with localized swelling of the tendon (Riley 2005, Riley
2008). Historically the terms *tendinitis* and *tendinosis* have interchanged
with the term *tendinopathy*, however, these definitions are now included in
the spectrum of human tendon disorders (*tendinopathy*). Tendinopathy is a
common overuse injury in the athletic and working populations; it is the most
common reason for consultation for a musculoskeletal complaint, corresponding
to around 30% of all such consultations with a general practitioner (Forde et
al 2005; Riley 2008). The exact incidence of overuse tendon injuries is not
known, but in sports medicine, they account for 30% to 50% of all injuries
(Scott and Ashe 2006). Generally, for physical workers, the prevalence of
musculoskeletal symptoms increases with duration of employment (Forde et al
2005).
Study objective
To assess the efficacy of secukinumab 300 mg s .c. vs. placebo in patients with
overuse rotator cuff tendinopathy in relieving clinical symptoms at week 14
Study design
This is a randomized, double-blind, placebo-controlled, multi-center, Phase II
study of s.c. secukinumab 300 mg in approximately 100 randomized patients with
overuse rotator-cuff tendinopathy without systemic inflammatory disease and
refractory to NSAIDs/acetaminophen, physiotherapy or corticosteroids.
The patient and investigator will be blinded throughout the study, while the
sponsor will be blinded until after the analysis of the primary endpoint.
The study consists of a 4-week screening period, a 2-week run-in period, a
12-week treatment period and a 12-week follow-up period after last treatment.
Intervention
Group 1: Secukinumab 300 mg s.c. (2 x 150 mg)
Group 2: Placebo s.c. (2 injections)
Study burden and risks
It is anticipated that secukinumab will have a beneficial effect on the
symptoms of rotator cuff tendinopathy, by inhibiting the IL-17 driven
inflammation and thereby decreasing pain and improving mobility and sleep.
Ultimately, this should result in few cases of tendinopathy
progressing to a tear and therefor lessen the need for surgery.
The placebo patients in the study will not have this benefit, however, they
will be followed closely in order to identify any progress or need for
additional therapy.
The risk to subjects in this trial will be minimized by compliance with the
eligibility criteria, close clinical monitoring and extensive guidance to the
investigators, provided in the current version of the Investigator*s Brochure
(IB).
Lichtstrasse 35
Basel CH-4056
CH
Lichtstrasse 35
Basel CH-4056
CH
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR201700309930-NL |
| CCMO | NL63318.056.17 |