A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee
Completed · Phase 2 · Has a placebo group
Conditions studied: Osteoarthritis, Knee
In brief
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.
Key facts
- Study ID
- NCT01919164
- Run by
- EMD Serono Research & Development Institute, Inc.
- People needed
- 549
- Starts
- 2013-07-29
- Expected to finish
- 2019-05-07
- Last updated by the study team
- 2020-07-13
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age from 40 to 85 years; of either sex
- Primary femorotibial osteoarthritis according to American College of Rheumatology (ACR) clinical and radiographic criteria , and meeting protocol-specified X-ray criteria in the target knee at screening
- Pain score in the target knee and/or the need for regular symptomatic treatment of knee pain with paracetamol (acetaminophen), systemic non-steroidal anti-inflammatory drugs (NSAIDs) including cyclooxygenase (COX)-2 selective inhibitors (coxibs), or tramadol on most days in the previous month (that is, more than half of the days in the previous month)
- A history of pain due to Osteoarthritis in the target knee for at least 6 months
- A protocol-specified pain score for the target knee in response to Question 1 of the WOMAC pain index ("how much pain have you had [in the target knee, over the past 48 hours] when walking on a flat surface?") after washout of at least 5 half-lives of analgesic medication(s): acetaminophen, topical or oral NSAIDS, coxibs, opioids, and/or tramadol
- Women of childbearing potential must use a form of contraception with a failure rate of less than 1 percent per year throughout the trial
You may not qualify if…
- Malalignment of greater than 5 degrees in the femorotibial axis of the target knee
- Clinical signs of inflammation (redness) in the target knee
- Intra-articular administration of corticosteroids or hyaluronic acid into either knee within 6 months before Screening
- Planned knee surgery (affecting either the target or the contralateral knee) within the next two years
- Concomitant conditions or treatments deemed to be incompatible with trial participation
- Any contraindication to MRI according to MRI guidelines, including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil
- Pregnancy or breastfeeding
- Participation in another clinical trial within the 30 days (or 5 half-lives of the investigated compound, whichever is longer) before screening
- Legal incapacity or limited legal capacity
Where it is running
- Research site — Lakewood, Colorado, United States
- Research site — Baltimore, Maryland, United States
- Research site — Buenos Aires, Argentina
- Research site — Brno, Czechia
- Research site — Pardubice, Czechia
- Research site — Prague, Czechia
- Research site — Aalborg, Denmark
- Research site — Ballerup Municipality, Denmark
- Research site — Vejle, Denmark
- Research site — Tallinn, Estonia
- Research Site — Hong Kong, Hong Kong
- Research site — Lodz, Poland
- Research site — Bucharest, Romania
Full record on ClinicalTrials.gov
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