NCT01919164

A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 549 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial of Sprifermin administered intra-articularly in participants with primary osteoarthritis of the knee and Kellgren-Lawrence Grade 2 or 3. The trial was intended to investigate the efficacy and safety of different intra articular dosages of Sprifermin in these individuals.

Detailed description

Participants were equally randomized to either one of 4 treatment arms or a placebo arm. The trial consists of a Screening period lasting up to 42 days, a two-year double-blind placebo-controlled (DBPC) treatment phase, which begins at randomization (Week 0) and ends at Year 2, and a 3-year extended follow-up phase.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Sprifermin	Participants received Sprifermin as intra-articular injection.
DRUG	Placebo	Participants received Placebo matched to sprifermin as intra-articular injection.

Timeline

• Start date: 2013-07-29
• Primary completion: 2016-05-05
• Completion: 2019-05-07
• First posted: 2013-08-08
• Last updated: 2020-07-13
• Results posted: 2020-07-13

Locations

13 sites across 8 countries: United States, Argentina, Czechia, Denmark, Estonia, Hong Kong, Poland, Romania