Osteoarthritis, Hip, Osteoarthritis, Knee
Conditions
Brief summary
The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: 1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip 3. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 4. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip 5. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip 6. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 7. To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 8. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 9. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 10. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
Interventions
DRUGNaproxen
Pharmaceutical form: Capsule
DRUGFasinumab-matching placebo
Solution for injection in pre-filled syringe
DRUGNaproxen-matching placebo
Capsule
DRUGFasinumab
Solution for injection in pre-filled syringe
Sponsors
Teva Pharmaceutical Industries, Ltd.
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo | Baseline to Week 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | Baseline to Week 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo | Baseline to Week 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | Baseline to Week 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores | Baseline to Week 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores | Week 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen | Baseline to Week 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo | Baseline to Week 44 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen | Baseline to Week 44 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo | Baseline to average score across weeks 4, 8, 12 and 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | Baseline to average score across weeks 36, 40 and 44 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen | Baseline to Week 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo | Baseline to Week 44 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen | Baseline to Week 44 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | Baseline to average score across weeks 4, 8, 12 and 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | Baseline to average score across weeks 36, 40 and 44 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | Baseline to Week 16 | The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). |
| Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen | Baseline to Week 16 | The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). |
| Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo | Baseline to Week 44 | The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). |
| Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen | Baseline to Week 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo | Baseline to Week 44 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo | Baseline to average score across weeks 4, 8, 12 and 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | Baseline to average score across weeks 36, 40 and 44 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen | Baseline to Week 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo | Baseline to Week 44 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | Baseline to average score across weeks 4, 8, 12 and 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores | Baseline to Week 16 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | Baseline to average score across weeks 36, 40 and 44 | The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. |
| Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1 | Baseline to Week 52 | — |
| Number of Participants With AA (as Confirmed by Adjudication) - Year 2 | First dose of study drug in Year 2 through week 104E | — |
| Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2 | Day 1 through week 104E (Extension) | — |
| Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1 | Baseline to Week 52 | — |
| Number of Participants With DA (as Confirmed by Adjudication) - Year 2 | First dose of study drug in Year 2 through week 104E | — |
| Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2 | Day 1 through week 104E | — |
| Number of Treatment Emergent Adverse Events (TEAEs) - Year 1 | Baseline to Week 52 | — |
| Number of TEAEs - Year 2 | First dose of study drug in Year 2 through week 104E | — |
| Number of TEAEs - Year 1 and Year 2 | Day 1 through week 104E | — |
| Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 | Baseline to Week 52 | — |
| Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2 | First dose of study drug in Year 2 through week 104E | — |
| Number of Participants With Any Type of All-Cause JR in Year 2 | First dose of study drug in Year 2 through week 104E | — |
| Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2 | Day 1 through week 104E | — |
| Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2 | Day 1 through week 104E | — |
| Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1 | Baseline to Week 52 | — |
| Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2 | First dose of study drug in Year 2 through week 104E | — |
| Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2 | Day 1 through week 104E | — |
| Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 | Baseline to Week 52 | — |
| Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | Baseline to Week 16 | The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). |
| Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen | Baseline to Week 16 | The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). |
| Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo | Baseline to Week 44 | The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). |
Countries
Denmark, Germany, Hungary, Lithuania, Poland, Romania, Russia, South Africa, Spain, Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 9157 participants were screened. Of those, 5850 were screen failures. 3307 participants were randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID) | 354 |
| Naproxen Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID | 1,063 |
| Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID | 551 |
| Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID | 1,054 |
| Fasinumab 3mg Q4W Fasinumab 3 mg SC Q4W and naproxen-matching placebo PO, BID | 145 |
| Fasinumab 6mg Q8W Fasinumab 6 mg SC Q8W and naproxen-matching placebo PO, BID | 140 |
| Total | 3,307 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 21 | 16 | 35 | 2 | 1 |
| Overall Study | Death | 3 | 9 | 7 | 9 | 0 | 0 |
| Overall Study | Lack of Efficacy | 9 | 13 | 9 | 24 | 4 | 1 |
| Overall Study | Lost to Follow-up | 3 | 12 | 4 | 7 | 8 | 13 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 2 | 17 | 15 |
| Overall Study | Protocol Violation | 11 | 14 | 6 | 13 | 1 | 0 |
| Overall Study | Unknown - Not reported | 0 | 1 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 24 | 73 | 44 | 97 | 11 | 10 |
Baseline characteristics
| Characteristic | Placebo | Naproxen | Fasinumab 1 mg SC Q8W | Fasinumab 1 mg SC Q4W | Fasinumab 3mg Q4W | Fasinumab 6mg Q8W | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized 18-64 years | 212 Participants | 608 Participants | 300 Participants | 584 Participants | 91 Participants | 81 Participants | 1876 Participants |
| Age, Customized 65 - 84 years | 140 Participants | 449 Participants | 247 Participants | 463 Participants | 53 Participants | 57 Participants | 1409 Participants |
| Age, Customized 85 years and over | 2 Participants | 6 Participants | 4 Participants | 7 Participants | 1 Participants | 2 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 26 Participants | 13 Participants | 38 Participants | 6 Participants | 6 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 339 Participants | 1032 Participants | 537 Participants | 1015 Participants | 139 Participants | 134 Participants | 3196 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 35 Participants | 29 Participants | 37 Participants | 3 Participants | 1 Participants | 116 Participants |
| Race (NIH/OMB) Black or African American | 109 Participants | 315 Participants | 166 Participants | 308 Participants | 47 Participants | 47 Participants | 992 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 23 Participants | 79 Participants | 48 Participants | 79 Participants | 6 Participants | 6 Participants | 241 Participants |
| Race (NIH/OMB) White | 211 Participants | 633 Participants | 307 Participants | 630 Participants | 89 Participants | 86 Participants | 1956 Participants |
| Sex: Female, Male Female | 265 Participants | 807 Participants | 419 Participants | 793 Participants | 96 Participants | 98 Participants | 2478 Participants |
| Sex: Female, Male Male | 89 Participants | 256 Participants | 132 Participants | 261 Participants | 49 Participants | 42 Participants | 829 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 352 | 13 / 1,056 | 12 / 554 | 13 / 1,052 | 0 / 145 | 0 / 139 |
| other Total, other adverse events | 215 / 352 | 687 / 1,056 | 382 / 554 | 727 / 1,052 | 41 / 145 | 58 / 139 |
| serious Total, serious adverse events | 49 / 352 | 103 / 1,056 | 81 / 554 | 175 / 1,052 | 7 / 145 | 6 / 139 |
Outcome results
Primary
Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 16
Population: Modified Full Analysis Set (mFAS) analysis population; The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo | -1.82 Score on a scale | Standard Error 0.162 |
| Fasinumab 1 mg SC Q4W | Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo | -2.49 Score on a scale | Standard Error 0.098 |
p-value: 0.000295% CI: [-1.028, -0.324]Mixed Models Analysis
Primary
Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 16
Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo | -2.09 Score on a scale | Standard Error 0.231 |
| Fasinumab 1 mg SC Q4W | Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo | -2.19 Score on a scale | Standard Error 0.144 |
p-value: 0.703695% CI: [-0.594, 0.401]Mixed Models Analysis
Primary
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 16
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | -1.71 Score on a scale | Standard Error 0.161 |
| Fasinumab 1 mg SC Q4W | Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | -2.42 Score on a scale | Standard Error 0.096 |
p-value: <0.000195% CI: [-1.046, -0.346]Mixed Models Analysis
Primary
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 16
Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | -1.91 Score on a scale | Standard Error 0.223 |
| Fasinumab 1 mg SC Q4W | Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | -2.09 Score on a scale | Standard Error 0.137 |
p-value: 0.460595% CI: [-0.657, 0.297]Mixed Models Analysis
Secondary
Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Time frame: Baseline to Week 16
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | -0.64 Score on a scale | Standard Error 0.064 |
| Fasinumab 1 mg SC Q4W | Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | -0.92 Score on a scale | Standard Error 0.04 |
Secondary
Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Time frame: Baseline to Week 16
Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | -0.79 Score on a scale | Standard Error 0.094 |
| Fasinumab 1 mg SC Q4W | Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | -0.77 Score on a scale | Standard Error 0.057 |
Secondary
Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Time frame: Baseline to Week 16
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen | -0.78 Score on a scale | Standard Error 0.04 |
| Fasinumab 1 mg SC Q4W | Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen | -0.92 Score on a scale | — |
Secondary
Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Time frame: Baseline to Week 16
Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen | -0.82 Score on a scale | Standard Error 0.057 |
| Fasinumab 1 mg SC Q4W | Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen | -0.77 Score on a scale | Standard Error 0.057 |
Secondary
Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Time frame: Baseline to Week 44
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo | -0.60 Score on a scale | Standard Error 0.074 |
| Fasinumab 1 mg SC Q4W | Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo | -0.79 Score on a scale | Standard Error 0.043 |
Secondary
Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Time frame: Baseline to Week 44
Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo | -0.74 Score on a scale | Standard Error 0.1115 |
| Fasinumab 1 mg SC Q4W | Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo | -0.75 Score on a scale | Standard Error 0.064 |
Secondary
Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to average score across weeks 36, 40 and 44
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | -1.57 Score on a scale | Standard Error 0.184 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | -2.06 Score on a scale | Standard Error 0.118 |
Secondary
Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to average score across weeks 36, 40 and 44
Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | -1.69 Score on a scale | Standard Error 0.271 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | -1.80 Score on a scale | Standard Error 0.169 |
Secondary
Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to average score across weeks 4, 8, 12 and 16
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | -1.46 Score on a scale | Standard Error 0.14 |
| Fasinumab 1 mg SC Q4W | Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | -2.30 Score on a scale | Standard Error 0.09 |
Secondary
Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to average score across weeks 4, 8, 12 and 16
Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | -1.73 Score on a scale | Standard Error 0.202 |
| Fasinumab 1 mg SC Q4W | Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | -2.11 Score on a scale | Standard Error 0.131 |
Secondary
Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 16
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen | -2.42 Score on a scale | Standard Deviation 2.095 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen | -2.88 Score on a scale | Standard Deviation 2.099 |
Secondary
Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 16
Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen | -2.41 Score on a scale | Standard Error 0.155 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen | -2.53 Score on a scale | Standard Error 0.154 |
Secondary
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 44
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen | -2.15 Score on a scale | Standard Error 0.115 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen | -2.20 Score on a scale | Standard Error 0.114 |
Secondary
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 44
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo | -1.69 Score on a scale | Standard Error 0.188 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo | -2.20 Score on a scale | Standard Error 0.114 |
Secondary
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 44
Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo | -1.77 Score on a scale | Standard Error 0.276 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo | -1.99 Score on a scale | Standard Error 0.163 |
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to average score across weeks 36, 40 and 44
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | -1.50 Score on a scale | Standard Error 0.172 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo | -1.99 Score on a scale | Standard Error 0.113 |
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to average score across weeks 36, 40 and 44
Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | -1.62 Score on a scale | Standard Error 0.261 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo | -1.69 Score on a scale | Standard Error 0.166 |
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to average score across weeks 4, 8, 12 and 16
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo | -1.37 Score on a scale | Standard Error 0.137 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo | -2.25 Score on a scale | Standard Error 0.088 |
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to average score across weeks 4, 8, 12 and 16
Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo | -1.61 Score on a scale | Standard Error 0.196 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo | -2.04 Score on a scale | Standard Error 0.127 |
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 16
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen | -1.98 Score on a scale | Standard Error 0.101 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen | -2.42 Score on a scale | Standard Error 0.096 |
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 16
Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen | -2.04 Score on a scale | Standard Error 0.14 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen | -2.09 Score on a scale | Standard Error 0.137 |
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 44
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen | -2.00 Score on a scale | Standard Error 0.113 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen | -2.07 Score on a scale | Standard Error 0.109 |
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 44
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo | -1.60 Score on a scale | Standard Error 0.186 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo | -2.07 Score on a scale | Standard Error 0.109 |
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 44
Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo | -1.76 Score on a scale | Standard Error 0.262 |
| Fasinumab 1 mg SC Q4W | Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo | -1.90 Score on a scale | Standard Error 0.157 |
Secondary
Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2
Time frame: Day 1 through week 104E (Extension)
Population: SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2 | 6 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2 | 33 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2 | 50 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2 | 152 Participants |
Secondary
Number of Participants With AA (as Confirmed by Adjudication) - Year 2
Time frame: First dose of study drug in Year 2 through week 104E
Population: The Year 2 safety analysis set (SAF - Year 2) includes all participants who received at least 1 dose of the Year 2 study drug; it is based on the treatment received during Year 2 (as treated); Here 'n' = Number of evaluable participants at a specified point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With AA (as Confirmed by Adjudication) - Year 2 | 2 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With AA (as Confirmed by Adjudication) - Year 2 | 7 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With AA (as Confirmed by Adjudication) - Year 2 | 11 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With AA (as Confirmed by Adjudication) - Year 2 | 53 Participants |
Secondary
Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1
Time frame: Baseline to Week 52
Population: The Year 1 safety analysis set (SAF - Year 1) includes all randomized patients from the FAS who received any study drug; it is based on the treatment received (as treated); Here 'n' = Number of evaluable participants at a specified point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1 | 4 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1 | 27 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1 | 40 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1 | 102 Participants |
Secondary
Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1
Time frame: Baseline to Week 52
Population: Safety Analysis Set (SAF)-Year 1. For participants with events, number of participant years is calculated up to the date of the first event; for participants without event, it corresponds to the length of the study participation in Year 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1 | 12 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1 | 33 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1 | 31 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1 | 67 Participants |
Secondary
Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2
Time frame: Day 1 through week 104E
Population: SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2 | 19 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2 | 47 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2 | 44 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2 | 100 Participants |
Secondary
Number of Participants With Any Type of All-Cause JR in Year 2
Time frame: First dose of study drug in Year 2 through week 104E
Population: SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; arm assignment was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Any Type of All-Cause JR in Year 2 | 22 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With Any Type of All-Cause JR in Year 2 | 12 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With Any Type of All-Cause JR in Year 2 | 33 Participants |
Secondary
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1
Time frame: Baseline to Week 52
Population: Safety Analysis Set (SAF) - Year 1 included participants randomized to fasinumab 1 mg Q4W, fasinumab 1 mg Q8W, naproxen, and placebo. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 | 18 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 | 43 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 | 29 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 | 70 Participants |
Secondary
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2
Time frame: Day 1 through week 104E
Population: SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2 | 23 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2 | 51 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2 | 35 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2 | 82 Participants |
Secondary
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2
Time frame: First dose of study drug in Year 2 through week 104E
Population: SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; arm assignment was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2 | 16 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2 | 6 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2 | 12 Participants |
Secondary
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1
Time frame: Baseline to Week 52
Population: The Year 1 safety analysis set (SAF - Year 1) includes all randomized patients from the FAS who received any study drug; it is based on the treatment received (as treated); Here 'n' = Number of evaluable participants at a specified point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 | 1 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 | 0 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 | 0 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 | 0 Participants |
Secondary
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2
Time frame: Day 1 through week 104E
Population: SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2 | 1 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2 | 0 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2 | 0 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2 | 0 Participants |
Secondary
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2
Time frame: First dose of study drug in Year 2 through week 104E
Population: SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; arm assignment was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2 | 0 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2 | 0 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2 | 0 Participants |
Secondary
Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2
Time frame: Day 1 through week 104E
Population: SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2 | 0 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2 | 1 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2 | 2 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2 | 11 Participants |
Secondary
Number of Participants With DA (as Confirmed by Adjudication) - Year 2
Time frame: First dose of study drug in Year 2 through week 104E
Population: SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With DA (as Confirmed by Adjudication) - Year 2 | 0 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With DA (as Confirmed by Adjudication) - Year 2 | 0 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With DA (as Confirmed by Adjudication) - Year 2 | 0 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With DA (as Confirmed by Adjudication) - Year 2 | 4 Participants |
Secondary
Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1
Time frame: Baseline to Week 52
Population: The Year 1 safety analysis set (SAF - Year 1) includes all randomized patients from the FAS who received any study drug; it is based on the treatment received (as treated); Here 'n' = Number of evaluable participants at a specified point in time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1 | 0 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1 | 1 Participants |
| Fasinumab 1 mg SC Q8W | Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1 | 2 Participants |
| Fasinumab 1 mg SC Q4W | Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1 | 7 Participants |
Secondary
Number of TEAEs - Year 1 and Year 2
Time frame: Day 1 through week 104E
Population: SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of TEAEs - Year 1 and Year 2 | 1317 Events |
| Fasinumab 1 mg SC Q4W | Number of TEAEs - Year 1 and Year 2 | 4348 Events |
| Fasinumab 1 mg SC Q8W | Number of TEAEs - Year 1 and Year 2 | 2271 Events |
| Fasinumab 1 mg SC Q4W | Number of TEAEs - Year 1 and Year 2 | 4712 Events |
Secondary
Number of TEAEs - Year 2
Time frame: First dose of study drug in Year 2 through week 104E
Population: SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; arm assignment was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of TEAEs - Year 2 | 973 Events |
| Fasinumab 1 mg SC Q4W | Number of TEAEs - Year 2 | 277 Events |
| Fasinumab 1 mg SC Q8W | Number of TEAEs - Year 2 | 808 Events |
Secondary
Number of Treatment Emergent Adverse Events (TEAEs) - Year 1
Time frame: Baseline to Week 52
Population: The Year 1 safety analysis set (SAF - Year 1) includes all randomized participants from the FAS who received any study drug; it is based on the treatment received (as treated); Here 'n' = Number of evaluable participants at a specified point in time.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Treatment Emergent Adverse Events (TEAEs) - Year 1 | 1063 Events |
| Fasinumab 1 mg SC Q4W | Number of Treatment Emergent Adverse Events (TEAEs) - Year 1 | 3641 Events |
| Fasinumab 1 mg SC Q8W | Number of Treatment Emergent Adverse Events (TEAEs) - Year 1 | 1985 Events |
| Fasinumab 1 mg SC Q4W | Number of Treatment Emergent Adverse Events (TEAEs) - Year 1 | 3901 Events |
Secondary
Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Week 16
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores | 50.5 Percentage of participants |
| Fasinumab 1 mg SC Q4W | Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores | 56.2 Percentage of participants |
Secondary
Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 16
Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores | 43.9 Percentage of participants |
| Fasinumab 1 mg SC Q4W | Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores | 56.2 Percentage of participants |
Secondary
Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Time frame: Baseline to Week 16
Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores | 53.9 Percentage of participants |
| Fasinumab 1 mg SC Q4W | Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores | 52.3 Percentage of participants |