Trial · NCT02683239
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) | Baseline up to week 52 | |
| Primary | Number of Participants With Any Serious TEAE | Baseline up to week 52 | |
| Primary | Number of Participants With Any Adverse Event (AE) up to Week 72 | Baseline up to week 72 | |
| Primary | Number of Participants With Any Serious AE up to Week 72 | Baseline up to week 72 | |
| Primary | Number of Participants With Adjudicated Arthropathy (AA) | Baseline up to week 52 and week 72 | Adjudicated arthropathy (AA) is a composite term that encompasses the following conditions: Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis. AAs were also evaluated to determine if they met Destructive Arthropathy criteria. |
| Primary | Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria | Baseline up to week 52 and week 72 | DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee. |
| Primary | Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation | Baseline up to week 72 | Any participant with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an adverse event of special interest (AESI). |
| Primary | Number of Participants With Sympathetic Nervous System (SNS) Dysfunction | Baseline up to week 72 | Potential events of sympathetic nervous system (SNS) dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist. |
| Primary | Number of Participants With at Least One All-Cause Joint Replacement (JR) Surgery | Baseline up to weeks 52, 72, and end of study (52 weeks post last dose) | All joint replacement surgery events regardless of cause at weeks 52 and 72. An end of study phone contact was also conducted approximately 52 weeks following the last dose of study drug. |
| Primary | Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52 | Baseline to week 52 | Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the treatment period were reported. Clinical significance was determined by the investigator. |
| Primary | Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-Treatment up to Week 72 | End of treatment up to week 72 | Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the post-treatment period were reported. Clinical significance was determined by the investigator. |
| Primary | Number of Participants With Anti-drug Antibody (ADA) up to Week 72 | Baseline up to week 72 | Immunogenicity was characterized by ADA responses \& titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses less than (\<) 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, greater than or equal to (≥) 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the fasinumab ADA assay post first dose when baseline results = negative or missing. |
| Primary | Change From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score | 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. |
| Primary | Change From Baseline to Week 16 in WOMAC Physical Function Subscale Score | 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 | Change From Baseline to Week 16 in Patient Global Assessment (PGA) Score of Osteoarthritis | Baseline to Week 16 | The PGA of OA 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). |
| Secondary | Number of Participants With ≥30% Reduction From Baseline to Week 16 in the WOMAC Pain Subscale Score | 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. Participants who achieved a response, where response was defined as an improvement by ≥30% in WOMAC pain subscale score |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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