A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee
NCT ID: NCT01919164
Last Updated: 2020-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
549 participants
INTERVENTIONAL
2013-07-29
2019-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Placebo
Participants received Placebo matched to sprifermin as intra-articular injection.
Sprifermin (AS902330) 30 mcg/placebo - 2 Cycles
Participants received Sprifermin 30 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Sprifermin
Participants received Sprifermin as intra-articular injection.
Placebo
Participants received Placebo matched to sprifermin as intra-articular injection.
Sprifermin (AS902330) 30 mcg- 4 Cycles
Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Sprifermin
Participants received Sprifermin as intra-articular injection.
Sprifermin (AS902330) 100 mcg/Placebo (2 cycles)
Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Sprifermin
Participants received Sprifermin as intra-articular injection.
Placebo
Participants received Placebo matched to sprifermin as intra-articular injection.
Sprifermin (AS902330) 100 mcg- 4 Cycles
Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months.
Sprifermin
Participants received Sprifermin as intra-articular injection.
Interventions
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Sprifermin
Participants received Sprifermin as intra-articular injection.
Placebo
Participants received Placebo matched to sprifermin as intra-articular injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
85 Years
ALL
No
Sponsors
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Nordic Bioscience A/S
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible, MD
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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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
Countries
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References
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Conaghan PG, Katz N, Hunter DJ, Guermazi A, Hochberg MC, Somberg K, Clive J, Knight C, Johnson M, Zhao L, Goel N. Exploring a novel outcome measure of symptom progression in knee osteoarthritis utilizing a large randomized trial. Osteoarthritis Cartilage. 2025 Mar;33(3):383-390. doi: 10.1016/j.joca.2024.12.003. Epub 2024 Dec 28.
Eckstein F, Maschek S, Wirth W, Ladel C, Bihlet AR, Knight C, Somberg K, Zhao L. Unbiased analysis of knee cartilage thickness change over three years after sprifermin vs. placebo treatment - A post-hoc analysis from the phase 2B FORWARD study. Osteoarthr Cartil Open. 2024 Aug 23;6(4):100513. doi: 10.1016/j.ocarto.2024.100513. eCollection 2024 Dec.
Eckstein F, Hochberg MC, Guehring H, Moreau F, Ona V, Bihlet AR, Byrjalsen I, Andersen JR, Daelken B, Guenther O, Ladel C, Michaelis M, Conaghan PG. Long-term structural and symptomatic effects of intra-articular sprifermin in patients with knee osteoarthritis: 5-year results from the FORWARD study. Ann Rheum Dis. 2021 Aug;80(8):1062-1069. doi: 10.1136/annrheumdis-2020-219181. Epub 2021 May 7.
Guehring H, Moreau F, Daelken B, Ladel C, Guenther O, Bihlet AR, Wirth W, Eckstein F, Hochberg M, Conaghan PG. The effects of sprifermin on symptoms and structure in a subgroup at risk of progression in the FORWARD knee osteoarthritis trial. Semin Arthritis Rheum. 2021 Apr;51(2):450-456. doi: 10.1016/j.semarthrit.2021.03.005. Epub 2021 Mar 11.
Eckstein F, Kraines JL, Aydemir A, Wirth W, Maschek S, Hochberg MC. Intra-articular sprifermin reduces cartilage loss in addition to increasing cartilage gain independent of location in the femorotibial joint: post-hoc analysis of a randomised, placebo-controlled phase II clinical trial. Ann Rheum Dis. 2020 Apr;79(4):525-528. doi: 10.1136/annrheumdis-2019-216453. Epub 2020 Feb 25.
Hochberg MC, Guermazi A, Guehring H, Aydemir A, Wax S, Fleuranceau-Morel P, Reinstrup Bihlet A, Byrjalsen I, Ragnar Andersen J, Eckstein F. Effect of Intra-Articular Sprifermin vs Placebo on Femorotibial Joint Cartilage Thickness in Patients With Osteoarthritis: The FORWARD Randomized Clinical Trial. JAMA. 2019 Oct 8;322(14):1360-1370. doi: 10.1001/jama.2019.14735.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website Scope
US Medical Information website, Medical Resources
Other Identifiers
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2011-003059-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EMR700692_006
Identifier Type: -
Identifier Source: org_study_id
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