Phase 2
Completed N=549
A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT01919164 ↗
Enrolled (actual)
549
Serious AEs
33.1%
Results posted
Jul 2020
Primary outcomePrimary: Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 — -0.02; -0.01; 0.00; 0.02 millimeters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 |
-0.02; -0.01; 0.00; 0.02; 0.03 | — |
| SECONDARY Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 |
-18.51; -21.55; -15.40; -21.12; -23.34; -21.04 | — |
| SECONDARY Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 |
-1.2; -0.4; -0.5; -0.8; -1.1; -1.3 | — |
| SECONDARY Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 |
-16.6; -13.9; -17.0; -15.0; -16.7; -16.3 | — |
| SECONDARY Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 |
-0.10; -0.05; -0.04; 0.02; -0.04; -0.11 | — |
| SECONDARY Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint |
0.00; 0.00; -0.01; 0.01; 0.01; -0.01 | — |
| SECONDARY Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 |
0.0; 1.7; -3.2; 16.7; 16.5; -10.2 | — |
| SECONDARY Synovial Fluid Levels of Sprifermin/FGF-18 |
56876.4; 1006.5; 1386.1; 5896.4; 622.1; 3628.3 | — |
| SECONDARY Serum Levels of Sprifermin/FGF-18 |
NA; NA; NA; NA; NA | — |
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
Data sourced from ClinicalTrials.gov (NCT01919164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.