EUCTR2016-005020-29-BGActive, not recruitingPhase 1
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 - FACT OA1
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 2,845
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Key Inclusion Criteria for 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
- •a.Inadequate pain relief from acetaminophen/paracetamol AND
- •b.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, defined as using oral NSAIDs
- •at regularly prescribed doses for approximately 4 days per week over
- •the last 4 weeks (patients who are screen failures prior to the
- •randomization visit but who met the NSAID use criterion at screening
- •would still meet this criterion if they are eligible for rescreening)
- •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
- •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
- •Key Inclusion Criteria for Year 2
- •Note: Any Year 1 patient attending their week 52 visit on or after 26
- •March 2020 will no longer have the option to enroll into 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
- •6. 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
- •Are the trial subjects under 18? no
- +5 more not shown
Exclusion Criteria
- •Key Exclusion Criteria for Year 1:
- •1. Non-compliance with the NRS recording during the pre-randomization
- •period (4 or more
- •consecutive missed diary entries)
- •2. History or presence at the screening visit of non-OA inflammatory
- •joint disease (eg,
- •rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudogout,
- •spondyloarthropathy,
- •polymyalgia rheumatica, joint infections within the
- •disease of the spine, pelvis or femur, neuropathic disorders,
- •fibromyalgia,
- •tumors or infections of the spinal cord, or renal
- •osteodystrophy
- •History or presence on imaging of arthropathy (osteonecrosis,
- •subchondral
- •insufficiency fracture, rapidly progressive OA type 1 or type
- •stress fracture, recent stress fracture, neuropathic joint arthropathy,
- •dislocation (prosthetic hip dislocation is eligible), knee dislocation
- •dislocation is eligible), congenital hip dysplasia with
- •degenerative
- •joint disease, extensive subchondral cysts, evidence of
- •fragmentation or collapse, or primary metastatic tumor with the exception of chondromas or pathologic fractures during the screening
- •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 visit
- •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 one eventually became
- •8. History or presence at the screening visit of autonomic neuropathy,
- •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 (Shy-Drager syndrome)
- •10.History of naproxen intolerance, or existence of a medical condition
- •that is high risk for naproxen-associated complications (eg, high risk of
- •gastrointestinal bleed, previous ulcer, condition requiring use of anticoagulants
- •or anti-platelet therapy, or acute coronary syndrome)
- •Known allergy or sensitivity to doxycycline or related compounds, or
- •Poorly controlled diabetes (defined as any single value of
- •A1c [HbA1c] >9.0%) at the screening visit
- •Known history of human immunodeficiency virus infection
- •Known history of ocular herpes simplex virus, herpes simplex virus
- •virus encephalitis
- •History of sickle cell disease, including sickle cell anemia and ßthalassemia
- •Confirmed elevated screening alanine aminotransferase (ALT) or
- •aminotransferase (AST) =2.5 times the upper limit of normal
- •Resting heart rate of <50 beats per minute (bpm) or >100 bpm (by
- •sign assessment
- •as captured during electrocardiogram [ECG] assessment) at the
- +15 more not shown
Investigators
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