A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS (ALBATROSS)
Osteoarthritis, Knee
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Injections, Intra-Articular
Eligibility Criteria
Main Inclusion Criteria:
- Male or female patients ≥40 years old.
- Symptomatic primary knee osteoarthritis (ACR criteria) since ≥6 months prior to screening, Kellgren Lawrence Grade 2 or 3, and representing an indication for intra-articular drug injection.
- >50 mm VAS pain score assigned to the index knee at WOMAC VA 3.1-A1 (pain while walking on a flat surface).
- >125 mm VAS pain score assigned to the index knee at WOMAC VA 3.1 A subscore (total pain).
- Pain in the index knee on at least 50% of the days in the month preceding the screening.
Main Exclusion Criteria:
- Patients with Kellgren & Lawrence Grade I or IV (doubtful or severe) osteoarthritis of the knee.
- Knee condition representing an indication for surgery
- Patients with Inflammatory or crystal arthropathies, acute fractures, severe loss of bone density, bone necrosis.
- Patients with isolated patella-femoral syndrome or chondromalacia.
- Patients with OA predominant in the lateral compartment or any significant valgus deformity.
- Patients with any other disease or condition interfering with the free use and evaluation of the index knee for the 3 month duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis).
- Major injury or surgery to the index knee within the previous 12 months prior to screening.
- Severe hip osteoarthritis ipsilateral to index knee.
- Any pain >30 mm VAS that could interfere with the assessment of index knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee).
- Any pharmacological or non-pharmacological treatment started or changed during 4 weeks prior to randomisation or likely to be changed during the duration of the study
- Use of systemic or topical corticosteroids >10 mg prednisolone equivalent per day during 30 days prior to randomisation.
- Use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics) during 1 or 2 weeks prior to randomisation.
- Any intra-articular or local periarticular punction, injection or surgery to the index knee during the 6 months prior to screening.
Sites / Locations
- Centre Hospitalier Régional - Hôpital Porte Madeleine
- Hôtel Dieu - GHU Ouest
- Department of Rheumatology, Purpan University Hospital
- Rheumatologie/Immunologie - Rheumazentrum, Krankenhaus Doberan
- Klinik für Rheumatologie und Klinische Immunologie, Charité - Campus Charité Mitte
- Orthopädische Praxis Dr. Wagenitz
- ClinPharm International, Prüfzentrum Bochum
- ClinPharm International, Prüfzentrum Dresden
- Medizinische Klinik 3, Universität Erlangen-Nürnberg
- ClinPharm Prüfzentrum Frankfurt / aM
- ClinPharm Prüfzentrum Görlitz
- Clinical Research Hamburg
- Orthopädie Zentrum Altona
- ClinPharm International, Prüfzentrum Leipzig
- ClinPharm Prüfzentrum Magdeburg
- Servizio di Reumatologia, Ospedale Privato Accreditato Nigrisoli
- Dipartimento di Biomedicina - SOD Reumatologia - Azienda Ospedaliera Universitaria Careggi
- Dipartimento di Medicina Interna Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara Pisa
- Istituto di Reumatologia, "Policlinico Le Scotte" Università degli Studi di Siena
- Servicio de Reumatologia, Hospital de Basurto
- Servicio de Reumatologia, Hospital Universitario La Paz
- Servicio de Reumatologia, Corporacio Sanitaria Parc Tauli, Hospital de Sabadell
- Servicio de Reumatologia, Hospital Universitario Virgen Macarena
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Double dose MEN16132 0.125 mg
Double dose MEN16132 0.25 mg
Double dose MEN16132 0.5 mg
Single dose MEN16132 0.5 mg
Placebo
Intra-articular administration of two 0.125 mg doses of MEN16132 at 2-week interval.
Intra-articular administration of two 0.25 mg doses of MEN16132 at 2-week interval.
Intra-articular administration of two 0.5 mg doses of MEN16132 at 2-week interval.
Intra-articular administration of one 0.5 mg dose of MEN16132 followed by one intra-articular injection of placebo at 2-week interval.
Intra-articular administration of two doses of Placebo at 2-week interval.