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

Change From Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) Total Score

The RMDQ is a self-administered, 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 from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores are indicative of better function.

Time frame: Week 2, Week 4, Week 8, Week 12, Week 16

Change From Baseline to Week 16 in Patient Global Assessment (PGA) of Low Back Pain (LBP) Score

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.

Time frame: Week 2, Week 4, Week 8, Week 12, Week 16

Number of Participants Achieving ≥30% Reduction From Baseline to Week 16 in Average Daily LBPI NRS Score

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.

Time frame: Week 16

Change From Baseline to Week 16 in the Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Score

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 scale; total interference score ranges from 0-10 (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.

Time frame: Week 2, Week 4, Week 8, Week 12, Week 16

Number of Adjudicated Arthropathy (AA) Events

Adjudicated arthropathy (AA) is a composite term that encompasses the following conditions: Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.

Time frame: Up to Week 36

Number of Adjudicated Arthropathy (AA) Events Meeting Destructive Arthropathy (DA) Criteria

Destructive arthropathy (DA) is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive Osteoarthritis type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis.

Time frame: Up to Week 36

Number of Treatment-Emergent Adverse Events (TEAEs)

Treatment-emergent adverse events (TEAEs) are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.

Time frame: Up to Week 16

Number of Sympathetic Nervous System (SNS) Dysfunction Events

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 was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.

Time frame: Up to Week 36

Number of Peripheral Sensory Adverse Events (AEs) That Require a Neurology Consultation

Any peripheral sensory AE (eg, paraesthesia and hypoaesthesia) that required a neurology consultation.

Time frame: Up to Week 36

Number of All-Cause Joint Replacement (JR) Surgery Events

All joint replacement surgery events regardless of cause.

Time frame: Up to Week 36

Number of Joint Replacement (JR) Surgery Events Reported at Telephone Survey After Last Dose of Study Drug

An end of study phone contact was conducted approximately 52 weeks following the last dose of study drug (week 12) to evaluate the number of participants who had undergone or were scheduled for JR surgery.

Time frame: Up to Week 64

Number of Participants With at Least One Positive Anti-Drug Antibody (ADA) Assay

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.

Time frame: 16 Weeks

Serum Concentration of Functional Fasinumab Over Time

Summary of mean concentration of functional fasinumab are presented by nominal time point.

Time frame: Baseline, Week 2, Week 4, Week 8, Week 16