Imbert, O, Deckx, H, Bernard, K et al. (7 more authors) (2021) The design of a randomized, placebo-controlled, dose-ranging trial to investigate the efficacy and safety of the ADAMTS-5 inhibitor S201086/GLPG1972 in knee osteoarthritis. Osteoarthritis and Cartilage Open, 3 (4). 100209. ISSN 2665-9131
Abstract
Objective
This study aims to assess the efficacy of the anticatabolic ‘a disintegrin and metalloproteinase with thrombospondin motif-5’ (ADAMTS-5) inhibitor, S201086/GLPG1972, in slowing cartilage loss in participants with knee osteoarthritis (OA).
Design
ROCCELLA (NCT03595618) is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging, phase 2 trial. We plan to enrol a total of 852 participants with knee OA across 12 countries. Participants will be randomized 1:1:1:1 to receive 75, 150 or 300 mg S201086/GLPG1972, or placebo orally, once daily for 52 weeks. Eligible participants will be aged 40–75 years and have predominantly medial knee OA with centrally read Kellgren–Lawrence grade 2 or 3, OARSI atlas medial femorotibial joint space narrowing grade 1 or 2, and consistent moderate to severe baseline pain. The primary endpoint will be the change from baseline to week 52 in magnetic resonance imaging-assessed central medial femorotibial compartment cartilage thickness. Secondary endpoints will include other structural outcomes, and patient-reported outcomes, as well as safety and pharmacokinetic assessments. Study sites will be assessed for eligibility based on factors including imaging quality, and images will be centrally read and quality checked.
Conclusions
Using strict inclusion criteria and leading imaging techniques with stringent quality controls, the ROCCELLA trial will evaluate the efficacy of S201086/GLPG1972 in slowing cartilage loss in participants with knee OA. The selected eligibility criteria should enrich for participants with OA who experience sufficient cartilage loss to allow detection of a substantial treatment effect.
Metadata
Item Type: | Article |
---|---|
Authors/Creators: |
|
Copyright, Publisher and Additional Information: | © 2021 Galapagos NV. Published by Elsevier Ltd on behalf of Osteoarthritis Research Society International (OARSI). This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
Keywords: | Knee osteoarthritis; Cartilage; Clinical trial; Disease modification; Quantitative magnetic resonance imaging; ADAMTS-5 inhibitor |
Dates: |
|
Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Institute of Rheumatology & Musculoskeletal Medicine (LIRMM) (Leeds) > Musculoskeletal Medicine & Imaging (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 13 Sep 2021 10:43 |
Last Modified: | 13 Sep 2021 10:56 |
Status: | Published |
Publisher: | Elsevier |
Identification Number: | 10.1016/j.ocarto.2021.100209 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:178074 |