A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Sprifermin; Placebo
Intervention description: Participants received Sprifermin as intra-articular injection.; Participants received Placebo matched to sprifermin as intra-articular injection.
Intervention MeSH terms: Mitogens
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 549.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteoarthritis of knee; Recombinant Human Fibroblast Growth Factor-18 (rhFGF-18); Sprifermin; Placebo

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.
    

Eligibility criteria:

        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