Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA)… (NCT02683239) | Clinical Trial Compass
CompletedPhase 3
Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip
United States5,331 participantsStarted 2016-02-17
Plain-language summary
The primary objective of the study is to describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed OA of the knee or hip.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female ≥18 years of age at the screening visit
✓. 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
✓. Moderate to severe pain in the index joint defined as a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) average pain subscale score of ≥4
✓. A history of 12 weeks of analgesic use for OA of the knee or hip
✓. History of regular use of analgesic medications for OA pain
Exclusion criteria
✕. History or presence at the screening visit of non OA inflammatory joint disease
✕. History or presence on imaging of arthropathy, stress fracture, recent stress fracture, neuropathic joint arthropathy, hip dislocation, knee dislocation, 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 fracture during the screening period
✕. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
✕. Patient is not a candidate for MRI
✕. Is scheduled for a joint replacement surgery to be performed during the study period
✕. Systemic (i.e., oral or intramuscular) corticosteroids within 30 days prior to the screening visit.
What they're measuring
1
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE)
Timeframe: Baseline up to week 52
2
Number of Participants With Any Serious TEAE
Timeframe: Baseline up to week 52
3
Number of Participants With Any Adverse Event (AE) up to Week 72
Timeframe: Baseline up to week 72
4
Number of Participants With Any Serious AE up to Week 72
Timeframe: Baseline up to week 72
5
Number of Participants With Adjudicated Arthropathy (AA)
Timeframe: Baseline up to week 52 and week 72
6
Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria
Timeframe: Baseline up to week 52 and week 72
7
Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation
Timeframe: Baseline up to week 72
8
Number of Participants With Sympathetic Nervous System (SNS) Dysfunction
✕. History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
✕. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
Timeframe: Baseline up to week 72
9
Number of Participants With at Least One All-Cause Joint Replacement (JR) Surgery
Timeframe: Baseline up to weeks 52, 72, and end of study (52 weeks post last dose)
10
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52
Timeframe: Baseline to week 52
11
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-Treatment up to Week 72
Timeframe: End of treatment up to week 72
12
Number of Participants With Anti-drug Antibody (ADA) up to Week 72
Timeframe: Baseline up to week 72
13
Change From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score
Timeframe: Baseline to Week 16
14
Change From Baseline to Week 16 in WOMAC Physical Function Subscale Score