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Trial record 2 of 59 for:    regeneron | Open Studies

A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip (FACT OA1)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2017 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03161093
First received: May 18, 2017
Last updated: NA
Last verified: May 2017
History: No changes posted
  Purpose

The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with osteoarthritis (OA) of the knee or hip.

The secondary objectives of the study are:

  1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with OA of the knee or hip
  2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 52 weeks in patients with OA of the knee or hip
  3. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with OA of the knee or hip
  4. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with OA of the knee or hip
  5. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients for up to 52 weeks
  6. To evaluate the immunogenicity of fasinumab administered to patients for up to 52 weeks

Condition Intervention Phase
Osteoarthritis, Knee
Osteoarthritis, Hip
Drug: Fasinumab
Drug: Naproxen
Drug: Fasinumab-matching placebo
Drug: Naproxen-matching placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-blind, Multi-dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Change in the WOMAC pain subscale scores from baseline to week 16 in patients treated with fasinumab compared with that of patients treated with placebo [ Time Frame: Baseline to Week 16 ]
  • Change in the WOMAC physical function subscale scores from baseline to week 16 in patients treated with fasinumab compared with that of patients treated with placebo [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures:
  • Change in the Patient Global Assessment (PGA) scores from baseline to week 16 in patients treated with fasinumab compared with that of patients treated with placebo [ Time Frame: Baseline to Week 16 ]
  • Percentage of patients treated with fasinumab, compared with that of patients treated with placebo, who had a response at week 16, with response defined as an improvement by ≥30% in the WOMAC pain subscale scores [ Time Frame: Baseline to Week 16 ]
  • Change in WOMAC pain subscale scores from baseline to week 16 in patients treated with fasinumab, compared with that of patients treated with naproxen [ Time Frame: Baseline to Week 16 ]
  • Change in WOMAC physical function subscale scores from baseline to week 16 in patients treated with fasinumab, compared with that of patients treated with naproxen [ Time Frame: Baseline to Week 16 ]
  • Change in WOMAC pain subscale scores from baseline to week 52 in patients treated with fasinumab, compared with that of patients treated with placebo [ Time Frame: Baseline to Week 52 ]
  • Change in WOMAC physical function subscale scores from baseline to week 52 in patients treated with fasinumab, compared with that of patients treated with placebo [ Time Frame: Baseline to Week 52 ]
  • Change in the PGA scores from baseline to week 52 in patients treated with fasinumab compared with that of patients treated with placebo [ Time Frame: Baseline to Week 52 ]
  • Change in the PGA scores from baseline to week 16 in patients treated with fasinumab compared with that of patients treated with naproxen [ Time Frame: Baseline to Week 16 ]
  • Incidence of severe Adjudicated Arthropathy (AA) (as confirmed by adjudication) [ Time Frame: Baseline to Week 100 ]
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline to Week 100 ]
  • Incidence of AA (as confirmed by adjudication) [ Time Frame: Baseline to Week 100 ]
  • Incidence of sympathetic nervous system dysfunction [ Time Frame: Baseline to Week 100 ]
  • Incidence of all-cause joint replacement (JR) through week 52 and through the follow-up period [ Time Frame: Baseline to Week 72 ]

Estimated Enrollment: 3640
Anticipated Study Start Date: July 2017
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fasinumab dosing regimen 1
Fasinumab SC dosing regimen 1 and naproxen-matching placebo oral
Drug: Fasinumab
Solution for injection in pre-filled syringe
Other Name: REGN475
Drug: Naproxen-matching placebo
Capsule
Experimental: Fasinumab dosing regimen 2
Fasinumab SC dosing regimen 2 and naproxen-matching placebo oral
Drug: Fasinumab
Solution for injection in pre-filled syringe
Other Name: REGN475
Drug: Naproxen-matching placebo
Capsule
Experimental: Fasinumab dosing regimen 3
Fasinumab SC dosing regimen 3 and naproxen-matching placebo oral
Drug: Fasinumab
Solution for injection in pre-filled syringe
Other Name: REGN475
Drug: Naproxen-matching placebo
Capsule
Experimental: Fasinumab-matching placebo and naproxen Drug: Naproxen
Pharmaceutical form: Capsule
Drug: Fasinumab-matching placebo
Solution for injection in pre-filled syringe
Experimental: Fasinumab-matching placebo and naproxen-matching placebo Drug: Fasinumab-matching placebo
Solution for injection in pre-filled syringe
Drug: Naproxen-matching placebo
Capsule

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria include, but are not limited to, the following:

  1. Male and female patients, at least 18 years of age, at screening
  2. 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
  3. Moderate to severe pain in the index joint defined at both the screening and randomization visits
  4. Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments (paracetamol/acetaminophen to be taken as needed with a maximum daily dose of 2500 mg in Europe and 2600 mg in countries outside of Europe)
  5. A history of at least 12 weeks of inadequate pain relief or intolerance to analgesics used for pain due to OA of the knee or hip, as defined by:

    1. Intolerance to or inadequate pain relief from acetaminophen/paracetamol AND
    2. Intolerance to or inadequate pain relief from at least 1 opioid or tramadol, unwillingness to take opioid or tramadol therapy for a medically acceptable reason, or lack of access to an opioid or to tramadol
  6. Currently using a stable dose of NSAID.
  7. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the initial 16 weeks of treatment
  8. Stable treatment with glucosamine sulfate and chondroitin sulfate treatments must be stopped during the pre-randomization period
  9. 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
  10. Willing to maintain current activity and exercise levels throughout the study
  11. Willing and able to comply with clinic visits and study-related procedures and willing to provide follow-up information related to any JR surgery that occurs within the period of time covered by their intended participation in the study
  12. Able to understand and complete study-related questionnaires

Exclusion Criteria include, but are not limited to, the following:

  1. Non-compliance with the NRS recording during the pre-randomization period
  2. History or presence at the screening visit of non-OA inflammatory joint disease, Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
  3. History or presence on imaging of arthropathy, neuropathic joint arthropathy, hip or knee dislocation, extensive subchondral cysts, significant bone collapse or bone loss, or pathologic fractures
  4. Trauma to the index joint within 3 months prior to the screening visit
  5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
  6. Patient is not a candidate for MRI
  7. Is scheduled for a JR surgery to be performed during the study period or who would be unwilling or unable to undergo JR surgery if needed
  8. History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
  9. Evidence of autonomic neuropathy as defined in the SoAs
  10. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy multiple system atrophy
  11. History of naproxen intolerance
  12. Resting heart rate of <50 beats per minute (bpm) or >100 bpm at the screening or randomization visits
  13. History or presence of 2nd or 3rd degree heart block, 1st degree heart block with abnormal QRS complex, or bifascicular block by ECG assessment at the screening visit
  14. History or presence of orthostatic hypotension at the screening, prerandomization, or randomization visits
  15. History of poorly controlled hypertension
  16. Use of systemic corticosteroid within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit
  17. Exposure to an anti-NGF antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03161093

Contacts
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03161093     History of Changes
Other Study ID Numbers: R475-OA-1611
2016-005020-29 ( EudraCT Number )
Study First Received: May 18, 2017
Last Updated: May 18, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017