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NCT01919164 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee
A Phase 2 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 549
- Enrollment target
NCT01919164: Completed Phase 2 study, sponsored by EMD Serono Research & Development Institute.
NCT01919164 is a Phase 2 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 549 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (313% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01919164, a Phase 2 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 549 participants
- Enrollment target
Study 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.
Primary Outcome
The change in cartilage thickness at 2 years was calculated based on quantitative magnetic resonance imaging (qMRI).
Interventions
- DRUG Placebo
- DRUG Sprifermin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 549 participants |
| Start Date | 2013-07-29 |
| Est. Completion | 2019-05-07 |
| Phase | Phase 2 |
What the finished NCT01919164 record still lists
NCT01919164 is an interventional study that assigns participants to a tested intervention. The registered 549 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (313% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01919164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01919164 about?
NCT01919164 is a clinical study titled "A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee". 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...
What is the current status of trial NCT01919164?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 549 participants. The study started on 2013-07-29. Estimated completion is 2019-05-07.
What interventions are being tested in trial NCT01919164?
The interventions under investigation include: Placebo (DRUG), Sprifermin (DRUG).
Who is sponsoring clinical trial NCT01919164?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01919164's enrollment target sits among peer trials
549 62nd of 2000 higher than 1,939 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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