CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 549 enrolled
Drug / intervention
Sprifermin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01919164
NCT01919164Phase 2Completed
CompareCT.gov

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

EMD Serono Research & Development Institute, Inc.·interventional·Posted Aug 8, 2013·Updated Jul 13, 2020

In Brief

A Phase 2 clinical trial evaluating Sprifermin and Placebo for Osteoarthritis, Knee. Completed, enrolled 549 participants across 13 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesArgentina, Czechia, Denmark, Estonia, Hong Kong, Poland, Romania, United States
CollaboratorsNordic Bioscience A/S

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 8, 2013
Enrollment StartJul 29, 2013
Primary CompletionMay 5, 2016
Study CompletionMay 7, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.9 years ago

Interventions

Sprifermindrug

Participants received Sprifermin as intra-articular injection.

Placebodrug

Participants received Placebo matched to sprifermin as intra-articular injection.