Trial reportAnnals of the rheumatic diseases2020
Intra-articular sprifermin reduces cartilage loss in addition to increasing cartilage gain independent of location in the femorotibial joint: post-hoc analysis of a randomised, placebo-controlled phase II clinical trial.
Trial report in Annals of the rheumatic diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01919164 (A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Trial to Investigate the Efficacy and Safety of Different Intra Articular), which is not on this map. Cited by 44 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Trial to Investigate the Efficacy and Safety of Different Intra Articular (i.a.) Dosages of Sprifermin in Subjects With Primary Osteoarthritis of the Knee
Who cites it
44 citing papers in PubMed, 1 synthesis or guideline pooled it, 74 citations in OpenAlex.
- Efficacy and safety of sprifermin injection for knee osteoarthritis treatment: a meta-analysis.Arthritis research & therapy · 2021Pooled it
- A low cartilage formation and repair endotype predicts radiographic progression of symptomatic knee osteoarthritis.Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology · 2021Trial
- The impact of knee positioning on joint space width change: Data from the Osteoarthritis Initiative.Osteoarthritis and cartilage open · 2026Article
- Advances in cartilage imaging techniques.Nature reviews. Rheumatology · 2026Review
- FGF/FGFR signaling at the immune-stromal interface in autoimmune rheumatic diseases: from tissue remodeling to translational opportunities.Frontiers in immunology · 2026Review
- Biologic and regenerative strategies for osteoarthritis: advances in MSC, exosome, and PRP based therapies.Frontiers in pharmacology · 2026Review
- Increased TNN in Knee Osteoarthritis Accelerates Cartilage Damage via the Negative Regulation of AMPK-PPARγ Signalling.Journal of cellular and molecular medicine · 2025Article
- Cartilage loss is greater in knees with virtual joint replacement status than in matched controls without.Osteoarthritis and cartilage open · 2025Article
- Knee Osteoarthritis: Current Insights Into Pathophysiology and Non-surgical Management Options.Cureus · 2025Review
- ShapeMed-Knee: A Dataset and Neural Shape Model Benchmark for Modeling 3D Femurs.IEEE transactions on medical imaging · 2025Article
- Which Endpoints Should be Applied in Interventional Trials? -: From Single Uni-dimensional Assessment Tailored to a Drug's Mechanism of Action to Multi-Component Measures and Multi-Domain Composites.Osteoarthritis imaging · 2025Article
- FGF18 induces chondrogenesis and anti-osteoarthritic effects in a mouse model for TMJ degeneration.PloS one · 2025Article
- Fibroblast Growth Factors: Roles and Emerging Therapeutic Applications.Current drug targets · 2025Review
- Bioactive peptides and proteins for tissue repair: microenvironment modulation, rational delivery, and clinical potential.Military Medical Research · 2024Review
- Unbiased analysis of knee cartilage thickness change over three years after sprifermin vs. placebo treatment - A post-hoc analysis from the phase 2B FORWARD study.Osteoarthritis and cartilage open · 2024Article
- ShapeMed-Knee: A Dataset and Neural Shape Model Benchmark for Modeling 3D Femurs.medRxiv : the preprint server for health sciences · 2024Article
- Intra-articular sustained-release of pirfenidone as a disease-modifying treatment for early osteoarthritis.Bioactive materials · 2024Article
- Ultrasound Imaging in Knee Osteoarthritis: Current Role, Recent Advancements, and Future Perspectives.Journal of clinical medicine · 2024Review
- Biomarkers in osteoarthritis: current status and outlook - the FNIH Biomarkers Consortium PROGRESS OA study.Skeletal radiology · 2023Review
- Quantitative measurement of cartilage morphology in osteoarthritis: current knowledge and future directions.Skeletal radiology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesIn the phase II FGF-18 Osteoarthritis Randomized Trial with Administration of Repeated Doses (FORWARD) study, sprifermin demonstrated cartilage modification in the total femorotibial joint and in both femorotibial compartments by MRI in patients with knee osteoarthritis. Here, we evaluate whether sprifermin reduces cartilage loss and increases cartilage thickness, independent of location.
methodsPatients were randomised 1:1:1:1:1 to three once-weekly intra-articular injections of 30 µg sprifermin every 6 months (q6mo); 30 µg sprifermin every 12 months (q12mo); 100 µg sprifermin q6mo; 100 µg sprifermin q12mo; or placebo. Post-hoc analysis using thinning/thickening scores and ordered values evaluated femorotibial cartilage thickness change from baseline to 24 months independent of location. Changes were indirectly compared with those of Osteoarthritis Initiative healthy subjects.
resultsThinning scores were significantly lower for sprifermin 100 µg q6mo versus placebo (mean (95% CI) difference: 334 µm (114 to 554)), with a cartilage thinning score similar to healthy subjects. Thickening scores were significantly greater for sprifermin 100 µg q6mo, 100 µg q12mo and 30 µg q6mo versus placebo (mean (95% CI) difference: 425 µm (267 to 584); 450 µm (305 to 594) and 139 µm (19 to 259), respectively) and more than doubled versus healthy subjects.
conclusionsSprifermin increases cartilage thickness, and substantially reduces cartilage loss, expanding FORWARD primary results. TRIAL REGISTRATION NUMBER: NCT01919164.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.