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

CompletadoFase 2ClinicalTrials.gov

ID: NCT01919164Tipo: INTERVENTIONALInicio: 29 de jul de 2013Fin estimado: 7 de may de 2019

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

Participants were 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.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Sprifermin

Participants received Sprifermin as intra-articular injection.

drug

Placebo

Participants received Placebo matched to sprifermin as intra-articular injection.

Ubicaciones

Research site

Buenos Aires, Argentina

Patrocinadores

PrincipalEMD Serono Research & Development Institute, Inc.

ColaboradorNordic Bioscience A/S

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