TrialScout

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

All
Age
18+
Phase 3

Brief Summary

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



ClinicalTrials.gov Identifier: NCT03161093
Recruitment Status: Active, not recruiting
First Posted: 5/19/2017 12:00:00 AM
Last Update Posted: 6/13/2019 12:00:00 AM

Keywords

Osteoarthritis
Osteoarthritis, Hip
Osteoarthritis, Knee

Intervention/Treatment

Drug: Naproxen-matching placebo / Capsule

You may be eligible to join if...


inclusion criteria include, but are not limited to, the following:

year 1:

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 (acetaminophen/paracetamol) to be taken as needed with a maximum
daily dose of 2500 mg (countries where 500 mg strength tablets/capsules are available)
or 2600 mg (countries where 325 mg strength tablets/capsules are available)

5. a history of at least 12 weeks of analgesics use for pain due to oa of the knee or
hip, as defined by:

1. inadequate pain relief from acetaminophen/paracetamol and

2. intolerance to or inadequate pain relief from opioid or tramadol therapy,
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

year 2:

1. completed the treatment period of year 1

2. did not permanently discontinue study drug during year 1

3. received no less than 10 of the 13 planned doses of sc study drug during the treatment
period of year 1

4. provide informed consent for year 2

5. willing to continue to maintain current activity and exercise levels throughout year 2

You may NOT be eligible to join if...

include, but are not limited to, the following

1. non-compliance with the numeric rating scale (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. history or diagnosis of chronic autonomic failure syndrome including pure autonomic
failure, multiple system atrophy

10. history of naproxen intolerance, or existence of a medical condition that is high risk
for naproxen-associated complications

11. resting heart rate of <50 beats per minute (bpm) or >100 bpm at the screening or
randomization visits

12. history or presence of 2nd or 3rd degree heart block, 1st degree heart block with
abnormal complex of q, r, and s waves on an electrocardiogram (qrs) complex, or
bifascicular block by ecg assessment at the screening visit

13. history or presence of orthostatic hypotension at the screening, prerandomization, or
randomization visits

14. history of poorly controlled hypertension

15. 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

16. exposure to an anti-nerve growth factor (ngf) antibody prior to the screening visit or
known sensitivity or intolerance to anti-ngf antibodies

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