Trial Radar IA | ||
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Lo studio clinico NCT06976671 per Capsulite adesiva è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
A Study to Determine the Safety and Efficacy of Bevacizumab Administered Via Injection Into the Shoulder Joint of Participants With Adhesive Capsulitis (Frozen Shoulder) Fase II 28 Iniziato dallo sperimentatore Dose singola
A Phase II Proof-of-concept Study Evaluating the Safety and Efficacy of Bevacizumab in the Treatment of Adhesive Capsulitis
- MQ-SR-001
Frozen Shoulder
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleIntra-articular Bevacizumab Bevacizumab administered as a single-dose intra-articular injection at 4 dose levels (50mg, 100mg, 150mg, 200mg) | Bevacizumab intra-articular bevacizumab |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Evaluate the safety of bevacizumab over a 52-week period in participants with adhesive capsulitis | * Incidence of adverse events (including medically significant changes in physical assessments, laboratory assessments, vital signs, and electrocardiogram), and serious adverse events, at 7 days (V3), 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8)
* Incidence of adverse events and serious adverse events at 3 days (V2) | 52 Weeks |
Determine the maximum tolerated dose of intra-articular bevacizumab at 1 week (V3) per cohort | Maximum tolerated dose as defined as the highest dose where 0 out of 3 participants or no more than 1 out of 6 participants experienced any dose-limiting toxicity (defined as a grade 3 or higher adverse event as per Common Terminology Criteria for Adverse Events version 5.0 | From start of treatment to 1 week after treatment |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis | Change in passive global range of motion loss against contralateral shoulder at baseline (V1) versus 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8) | 52 weeks |
Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis | Change in pain levels (assessed by a visual analogue scale: 0 to 100, higher score indicating worse outcome) at baseline (V1) versus 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8). | 52 weeks |
Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis | Change in Shoulder Pain and Disability Index assessment (Roach, 1991) at baseline (V1) versus 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8) | 52 weeks |
Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis | Change in Quick Disabilities of the Arm, Shoulder and Hand assessment (Work and Health, 2006) at baseline (V1) versus 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8) | 52 weeks |
Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis | Categorical change in severity classification of global range of motion loss at baseline (V1) versus 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8) | 52 weeks |
IC1. Over 18 years of age (inclusive) at the time of signing informed consent
IC2. Clinical diagnosis of adhesive capsulitis which is defined as:
- Progressive pain and stiffness for a period greater than 2 months but less than 6 months; and,
- Either thickening or signal hyperintensity associated with coracohumeral ligament, axillary pouch, or rotator interval joint capsule OR obliteration of the subcoracoid fat triangle as confirmed by radiological examination (magnetic resonance imaging); and,
- Normal x-ray of the shoulder with no evidence of glenohumeral joint degenerative changes or sequelae of previous trauma.
IC3. Capable of giving signed informed consent as described in Section 14 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
IC4. Participants of child-bearing potential are eligible to participate if they agree to the following during the study intervention period and for a minimum of 120 days after the study intervention is administered:
- Female participants must not be pregnant or breastfeeding AND are either abstinent from heterosexual intercourse as their preferred usual lifestyle OR engage in an adequate method of contraception (i.e., the oral contraceptive pill, intrauterine device, or other)
- Male participants must refrain from donating sperm AND are either abstinent from heterosexual intercourse as their preferred usual lifestyle OR must agree to use an adequate method of contraception/barrier method (i.e. condom and/or heterosexual partner engaging in an adequate method of contraception as previously described)
IC5. Participants who are not of child-bearing potential, defined as at least one or more of the following criteria, are eligible to participate in the study
- Female participants in a post-menopausal state (defined as not experiencing menses for 12 consecutive months without an alternative cause)
- Documented permanent sterilisation method (including, but not limited to, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and vasectomy)
EC2. History of adhesive capsulitis in ipsilateral shoulder
EC3. Presence of trauma in the affected shoulder unrelated to adhesive capsulitis
EC4 Advanced imaging features associated with calcific tendinopathy
EC5. Presence of uncontrolled hypertension (defined as systolic pressure > 140mmHg and diastolic pressure > 100mmHg)
EC6. Any medical history of cardiovascular disease, uncontrolled ischemic heart disease, acute myocardial infarction within 12 months of study entry, or any history of intracranial hemorrhage, stroke or a transient ischaemic attacks at any time
EC7. Presence of inflammatory arthritis (such as but not limited to: systemic lupus erythematosus, rheumatoid arthritis, reactive arthritis, etc.), Parkinson's disease, brain injury, osteoarthritis, bony glenohumeral pathology, hypothyroidism, neuromuscular disorders, or pre-diabetes or diabetes mellitus (defined by fasting glucose ≥7mmol/L and Hba1c ≥ 5.7%)
EC8. Participants currently taking corticosteroids, monoclonal antibody therapy, or other immunosuppressants which are deemed to impact the study endpoints
EC9. Planning to or have received treatment for the affected shoulder at any time during the study or prior to the study included but not limited to:
- Intra-articular or intrabursal injection(s) of lidocaine, suprascapular nerve blocks; corticosteroids, electroanalgesic and/or thermoanalgesic modalities
- Intra-articular or intrabursal injection(s) of sodium hyaluronate and/or glenohumeral distension arthrography
- Surgical intervention
EC10. Progressive pain and stiffness in the affected shoulder that is for a period less than 2 months or greater than 6 months
EC11. Hypersensitivity to the study intervention, including any constituents thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
EC12. Any active malignancy under treatment
EC13. Women who are pregnant and/or breastfeeding, or who plan to be pregnant in the following six months after study intervention
EC14. Participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions that might affect their safety or ability to complete the protocol or that may confound the efficacy or safety results of the trial
EC15. Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with Section 1.61 of the ICH-GCP Ordinance E6)
EC16. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalised
EC17. Participants unable to provide written informed consent
EC18. Participants who have participated in other clinical trial within 1 month, have participated in another study within 6 months from the date of selection, or have planned for participation in another trial during the follow up period of this trial which is deemed by the Investigator to impact the planned study endpoints of this study
EC19. Acute illness within the 30 days prior to V1 that, in the opinion of the Investigator, affects the participant's ability to participate in the study.
EC20. Participants currently taking warfarin or any other anti-coagulation therapies.
EC21.Participants deemed with any condition which would preclude their use for study-related magnetic resonance imaging procedures, including but not limited to: morbid obesity, severe claustrophobia, and/or permanent pacemaker).
Macquarie University, AustraliaNew South Wales