A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin (AS902330) in Patients With Osteoarthritis of the Knee
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 40 - 85 |
| Updated: | 6/21/2018 |
| Start Date: | July 29, 2013 |
| End Date: | May 20, 2019 |
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
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2
trial of AS902330 administered intra-articularly in subjects with primary osteoarthritis of
the knee and Kellgren-Lawrence Grade 2 or 3. The trial is intended to investigate the
efficacy and safety of different intra articular dosages of AS902330 (Sprifermin) in these
individuals.
trial of AS902330 administered intra-articularly in subjects with primary osteoarthritis of
the knee and Kellgren-Lawrence Grade 2 or 3. The trial is intended to investigate the
efficacy and safety of different intra articular dosages of AS902330 (Sprifermin) in these
individuals.
Subjects will be 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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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