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Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee (FACT CLBP 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03285646
Recruitment Status : Completed
First Posted : September 18, 2017
Last Update Posted : August 31, 2020
Sponsor:
Collaborator:
Teva Pharmaceutical Industries, Ltd.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
The primary objective of the study is to evaluate the efficacy of fasinumab in relieving Chronic low back pain (CLBP) as compared to placebo in patients with a clinical diagnosis of moderate-to-severe non-radicular CLBP and Osteoarthritis (OA) of the knee or hip when treated for up to 16 weeks. The secondary objectives of the study are: To evaluate the safety and tolerability of fasinumab compared to placebo when patients with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To characterize the concentrations of fasinumab in serum over time when patients with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To evaluate the immunogenicity of fasinumab when treated for up to 16 weeks in patients with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Osteoarthritis Drug: Fasinumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee
Actual Study Start Date : October 30, 2017
Actual Primary Completion Date : May 5, 2018
Actual Study Completion Date : May 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fasinumab
Subcutaneous (SC) every 4 weeks (Q4W)
Drug: Fasinumab
Subcutaneous (SC) every 4 weeks (Q4W)
Other Name: REGN475

Placebo Comparator: Placebo
SC every 4 weeks
Drug: Placebo
Subcutaneous (SC) every 4 weeks (Q4W)




Primary Outcome Measures :
  1. Change from Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (NRS) Score [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16 ]
    Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.


Secondary Outcome Measures :
  1. Change from Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) Total Score [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 ]
    The RMDQ is a self-administered, widely used health status measure for lower back pain (LBP). It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked - that is from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores indicative of better function.

  2. Change from Baseline to Week 16 in Patient Global Assessment (PGA) of Low Back Pain (LBP) Score [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 ]
    The PGA of LBP is a participant assessed 5 point Likert scale of LBP ranging from 1-5 where 1 = very well; 2 = well; 3 = fair; 4 = poor; and 5 = very poor.

  3. Number of Participants Achieving ≥30% Reduction from Baseline to Week 16 in Average Daily LBPI NRS Score [ Time Frame: Baseline, Week 16 ]
    Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.

  4. Change from Baseline to Week 16 in the Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Score [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 ]
    The BPI-sf is a self-administered questionnaire (for participants to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. With a recall period of 24 hours, the questionnaire contains the front and back body diagrams, the 4 pain severity items and 7 pain interference items rated on 0-10 scales (0, does not interfere; 10 completely interferes), and the question about percentage of pain relief by analgesics. The BPI pain interference is typically scored as the mean of the 7 interference items.

  5. Number of Adjudicated Arthropathy (AA) Events [ Time Frame: Up to Week 36 ]
    Adjudicated arthropathy is an umbrella term that encompasses the following conditions; Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, Primary Osteonecrosis, and Destructive arthropathy

  6. Number of Destructive Arthropathy (DA) Events [ Time Frame: Up to Week 36 ]
    Destructive arthropathy (DA) is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA.

  7. Number of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to week 16 ]
    Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.

  8. Number of Sympathetic Nervous System (SNS) Dysfunction Events [ Time Frame: Up to Week 36 ]
    Potential events of sympathetic nervous system (SNS) dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction were only diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.

  9. Number of Peripheral Sensory AEs that Require a Neurology Consultation [ Time Frame: Up to Week 36 ]
    Any peripheral sensory AE (eg, paraesthesia and hypoaesthesia) that, per the investigator's judgment, requires a neurology consultation.

  10. Number of All-Cause Joint Replacement (JR) Surgery Events [ Time Frame: Up to Week 36 ]
    All joint replacement surgery events regardless of cause.

  11. Number of Joint Replacement Surgery Events Reported at Telephone Survey After Last Dose of Study Drug [ Time Frame: Up to Week 64 ]
    An end of study phone contact will be conducted approximately 52 weeks following the last dose of study drug to evaluate the number of participants who have undergone or are scheduled for JR surgery.

  12. Number of Participants With at Least One Positive Anti-Drug Antibody (ADA) Assay [ Time Frame: 16 Weeks ]
    Samples for Anti-Drug Antibody (ADA) evaluation were collected at baseline and at subsequent study visits. ADA variables include ADA status (+ or -) and titer as follows: Total participants negative in the ADA assay at all time points analyzed. Pre-existing immunoreactivity - positive response at baseline with all post-dose results negative, or a positive response at baseline with all post-dose responses less than 9-fold over baseline titer levels. Treatment emergent - post-dose positive result when baseline results were negative. Persistent - A positive result detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period, with no negative results in-between. Indeterminate - A positive result at the last collection time point analyzed only. Transient - Not persistent or indeterminate regardless of any missing samples. Treatment boosted - any post-dose positive result at least 9-fold over the baseline level when baseline is positive.

  13. Serum Concentration of Functional Fasinumab Over Time [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 16 ]
    Summary of mean concentration of functional fasinumab are presented by nominal time point.



Information from the National Library of Medicine

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

Key Inclusion Criteria:

  1. Clinical diagnosis of non-radicular moderate-to-severe CLBP for ≥3 months (prior to screening visit)
  2. Clinical diagnosis of OA in at least 1 hip or knee joint based on the American College of Rheumatology Criteria with radiographic evidence of OA (K-L ≥2) at screening
  3. History of inadequate relief of CLBP from non-pharmacologic therapy
  4. Willing to undergo joint replacement (JR) surgery, if necessary
  5. History of regular analgesic medication use
  6. History of inadequate pain relief or intolerance to analgesics used for chronic LBP

Key Exclusion Criteria:

  1. Patient is not a candidate for MRI
  2. History of major trauma or back surgery in the past 6 months prior to the screening visit
  3. History or presence of pyriformis syndrome
  4. Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions
  5. History or evidence on joint imaging of conditions that may confound joint safety evaluation
  6. Evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol
  7. Recent use of longer acting pain medications
  8. Other medical conditions that may interfere with participation or accurate assessments during the trial

Note: Other protocol defined Inclusion/ Exclusion criteria apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285646


Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Teva Pharmaceutical Industries, Ltd.
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03285646    
Other Study ID Numbers: R475-PN-1612
2017-001943-12 ( EudraCT Number )
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Knee
Hip
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Back Pain
Low Back Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Fasinumab
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs