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NCT03691974 | COMPLETED | Osteoarthritis, Knee

Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee
Sponsor:

Regeneron Pharmaceuticals

Brief Summary:

The primary objective of the study is to evaluate the effect of fasinumab compared to placebo on peripheral nerves in participants with pain due to Osteoarthritis (OA) of the hip or knee. The secondary objectives of the study are to: * Evaluate the efficacy of fasinumab compared to placebo in participants with pain due to OA of the hip or knee * Evaluate the safety and tolerability of fasinumab compared to placebo in participants with pain due to OA of the hip or knee * Characterize the concentrations of fasinumab in serum in participants with pain due to OA of the hip or knee * Evaluate the immunogenicity of fasinumab in participants with pain due to OA of the hip or knee.

Condition or disease

Osteoarthritis, Knee

Osteoarthritis, Hip

Intervention/treatment

Fasinumab

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 180 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee
Actual Study Start Date : 2018-10-15
Estimated Primary Completion Date : 2020-01-30
Estimated Study Completion Date : 2021-01-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • 1. A clinical diagnosis of OA of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit
  • 2. Moderate-to-severe pain in the index joint defined as a WOMAC average pain subscale score of ≥4 at both the screening and randomization visits
  • 3. Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments
  • 4. A history of regular use of analgesic medications for OA pain (defined as an average of 4 days per week over the 4 weeks prior to the screening visit), including oral nonsteroidal anti-inflammatory drugs (NSAIDs), selective cyclooxygenase 2 inhibitors, opioids, paracetamol/acetaminophen, or combinations thereof
  • 5. Consent to allow all radiographs and medical/surgical/hospitalization records of care received elsewhere prior to and during the study period to be shared with the investigator
  • Key Exclusion Criteria
    • 1. History or presence at the screening visit of non-OA inflammatory joint disease (eg, rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudo-gout, gout, spondyloarthropathy, polymyalgia rheumatica, joint infections within the past 5 years), Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
    • 2. History or presence on imaging of arthropathy (osteonecrosis, subchondral insufficiency fracture, rapidly progressive OA type 1 or type 2), stress fracture, recent stress fracture, neuropathic joint arthropathy, hip dislocation (prosthetic hip dislocation is eligible), knee dislocation (patella dislocation is eligible), congenital hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence of bone fragmentation or collapse, or primary metastatic tumor with the exception of chondromas or pathologic fractures during the screening period
    • 3. Trauma to the index joint within 3 months prior to the screening visit
    • 4. History or presence of signs or symptoms of compression neuropathy, including carpal tunnel syndrome or sciatica
    • 5. Participant is not a candidate for Magnetic Resonance Imaging (MRI)
    • 6. Poorly controlled diabetes
    • 7. Known history of human immunodeficiency virus (HIV) infection
    • 8. Known history of ocular herpes simplex virus, herpes simplex virus pneumonia, or herpes simplex virus encephalitis
    • 9. History of poorly controlled hypertension
    • 10. Known history of infection with hepatitis B or C virus
    • Note: Other protocol defined Inclusion/Exclusion apply
Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee

Location Details

NCT03691974

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Arizona

Regeneron Study Site

Glendale, Arizona, United States, 85306

Not yet recruiting

United States, Arizona

Regeneron Study Site

Glendale, Arizona, United States, 85308

Not yet recruiting

United States, Arizona

Regeneron Study Site

Phoenix, Arizona, United States, 85053

Not yet recruiting

United States, Arizona

Regeneron Study Site

Tucson, Arizona, United States, 85412

Not yet recruiting

United States, California

Regeneron Study Site

Anaheim, California, United States, 92805

Not yet recruiting

United States, Florida

Regeneron Study Site

Clearwater, Florida, United States, 33756

Not yet recruiting

United States, Florida

Regeneron Study Site

Jacksonville, Florida, United States, 32256

Not yet recruiting

United States, Florida

Regeneron Study Site

Miami, Florida, United States, 33165

Not yet recruiting

United States, Florida

Regeneron Study Site

Ocoee, Florida, United States, 34761

Not yet recruiting

United States, Florida

Regeneron Study Site

Orlando, Florida, United States, 32808

Not yet recruiting

United States, Georgia

Regeneron Study Site

Woodstock, Georgia, United States, 30189

Not yet recruiting

United States, Illinois

Regeneron Study Site

Chicago, Illinois, United States, 60607

Not yet recruiting

United States, Illinois

Regeneron Study Site

Chicago, Illinois, United States, 60611

Not yet recruiting

United States, Road cancer

Regeneron Study Site

Caro, Road cancer, United States, 48723

Not yet recruiting

United States, New York

Regeneron Study Site

Hartsdale, New York, United States, 10530

Not yet recruiting

United States, Ohio

Regeneron Study Site

Cincinnati, Ohio, United States, 45224

Not yet recruiting

United States, Ohio

Regeneron Study Site

Columbus, Ohio, United States, 43235

Not yet recruiting

United States, Texas

Regeneron Study Site

Bellaire, Texas, United States, 77401

Not yet recruiting

United States, Texas

Regeneron Study Site

Houston, Texas, United States, 77004

Not yet recruiting

United States, Texas

Regeneron Study Site

Houston, Texas, United States, 77058

Not yet recruiting

United States, Texas

Regeneron Study Site

San Antonio, Texas, United States, 72858

Not yet recruiting

Poland, Donnoslav

Regeneron Study Site

Wroclaw, Donnoslav, Poland, 50-381

Not yet recruiting

Poland, Lodz

Regeneron Study Site

Lodz, Lodzkie, Poland, 91-211

Not yet recruiting

Poland, Masovian

Regeneron Study Site

Warsaw, Masovian Voivodeship, Poland, 01-192

Not yet recruiting

Poland, Pomeranian

Regeneron Study Site

Gdansk, Pomeranian, Poland, 80-382

Not yet recruiting

Poland, Pomeranian

Regeneron Study Site

Gdynia, Pomeranian, Poland, 81-537

Not yet recruiting

Poland, Silesian

Regeneron Study Site

Czestochowa, Slaskie, Poland, 42-202

Not yet recruiting

Poland, Silesian

Regeneron Study Site

Katowice, Slaskie, Poland, 40-040

Not yet recruiting

Poland, Greater Poland

Regeneron Study Site

Poznan, Greater Poland, Poland, 60-702

Not yet recruiting

Poland,

Regeneron Study Site

Lodz, Poland, 90-127

Not yet recruiting

United Kingdom, Greater London

Regeneron Study Site

London, Greater London, United Kingdom, Wc1x8qd

Not yet recruiting

United Kingdom,

Regeneron Study Site

Chorley, United Kingdom, Hanna

Not yet recruiting

United Kingdom,

Regeneron Study Site

Corby, United Kingdom, Nun 172 and w

Not yet recruiting

United Kingdom,

Regeneron Study Site

Edgbaston, United Kingdom, B15 2SQ

Not yet recruiting

United Kingdom,

Regeneron Study Site

Glasgow, United Kingdom, G20 0SP

Not yet recruiting

United Kingdom,

Regeneron Study Site

Hardwick, United Kingdom, C19 8pe

Not yet recruiting

United Kingdom,

Regeneron Study Site

Hexham, United Kingdom, Ne46 1QJ

Not yet recruiting

United Kingdom,

Regeneron Study Site

Kenilworth, United Kingdom, CV81JD

Not yet recruiting

United Kingdom,

Regulatory Study Site

London, United Kingdom, Yes146lt

Not yet recruiting

United Kingdom,

Regeneron Study Site

London, United Kingdom, RG401XS

Not yet recruiting

United Kingdom,

Regeneron Study Site

London, United Kingdom, RM13PJ

Not yet recruiting

United Kingdom,

Regeneron Study Site

Manchester, United Kingdom, M15 6SX

Not yet recruiting

United Kingdom,

Regeneron Study Site

Northwood, United Kingdom, HA62RN

Not yet recruiting

United Kingdom,

Regeneron Study Site

Peterborough, United Kingdom, Hurry

Not yet recruiting

United Kingdom,

Regeneron Study Site

Reading, United Kingdom, RG2 0TG

Not yet recruiting

United Kingdom,

Regeneron Study Site

Shipley, United Kingdom, BD183SL

Not yet recruiting

United Kingdom,

Regeneron Study Site

Waterloo, United Kingdom, L22 0LG