Study to determine the safety and the efficacy of fasinumab compared to placebo and NSAIDs for treatment of adults with pain from osteoarthritisof the knee or hip

Phase 1

• Conditions: Pain due to osteoarthritis of the knee or hip; MedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859; MedDRA version: 21.1Level: LLTClassification code 10020108Term: Hips osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2017-001702-15-EE
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-08
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1620

Inclusion Criteria

Key Inclusion Criteria (additional criteria may apply at screening):
1. Male and female patients, at least 18 years of age, at screening
2. Provide signed informed consent
3. Body mass index =39 at screening visit
4. 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, with the following definitions:
-The index joint is defined as the joint with OA under evaluation for this study
-A joint previously treated with JR surgery cannot be the index joint
-A joint previously surgically modified within the past year cannot be the index joint (with the exception of cruciate ligament reconstruction surgery, patellar fracture repair surgery, or meniscal repair)
-If a patient has a K-L score of =2 at more than 1 knee or hip joint, the index joint is the joint with the greatest WOMAC pain subscore at the
screening visit.
- If 2 or more knee or hip joints have a K-L score of =2 and the same WOMAC pain subscore, the index joint is the joint with the greater K-L score.
- If 2 or more joints have a K-L score of =2, the same WOMAC pain subscores, and the same K-L scores, then the investigator may choose 1 of these joints as the index joint
5. Moderate to severe pain in the index joint defined as a WOMAC average pain subscale score of =4 at both the screening and randomization visits
6. 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])
7. A history of at least 12 weeks of analgesic 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
8. 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)
9. Willing to continue a stable dose of oral NSAID during the screening period, defined as using NSAIDs for approximately 4 days per week
10. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the 24 weeks of treatment
11. Stable treatment with glucosamine sulfate and chondroitin sulfate treatments must be stopped during the pre-randomization period
12. 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
13. Willing to maintain current activity and exercise levels throughout the study
14. 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
15. Able to understand and complete study-related questionnaires
Are the trial subjects under 18? no
Numbe

Exclusion Criteria

Key Exclusion Criteria (additional criteria may apply at screening):
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, hip or knee dislocation, extensive subchondral cysts, evidence of severe structural damage, bone collapse, or primary metastatic tumor with the exception of chondromas 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 magnetic resonance imaging (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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified