Trial · NCT03304379
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo | Baseline up to Week 24 | This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, Number of Subjects Analysed signifies those subjects who were evaluable for this endpoint. Modified full analysis set (mFAS) includes all randomized participants in FAS but excludes participants from 4 sites for which there were potential concerns regarding data quality, identified prior to database lock. | Score on a Scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo | Baseline up to Week 24 | This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, Number of Participants Analyzed signifies those participants who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo | Baseline up to Week 24 | The FAS included all randomized participants excluding participants affected by the urgent safety measure and was based on the treatment allocated (as randomized). As pre-specified in the protocol, efficacy data from participants randomized to Fasinumab 1 mg Q4W and placebo was only included in the analysis for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo | Baseline up to Week 24 | This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, Number of Participants Analyzed signifies those participants who were evaluable for this endpoint. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in WOMAC Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs | Baseline up to Week 24 | This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, Number of Participants Analyzed signifies those participants who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs | Baseline up to Week 24 | This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, Number of Subjects Analysed signifies those subjects who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs | Baseline up to Week 24 | This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, Number of Participants Analyzed signifies those participants who were evaluable for this endpoint. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Average Walking Index Joint Pain Score up to Week 24 by Using the Numeric Rating Scale (NRS) Pain Scale | Baseline up to Week 24 | This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. Here, Number of Participants Analyzed signifies those participants who were evaluable for this endpoint. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Adjudicated Arthropathy (AA) Events | Baseline up to follow-up period (Week 44) | This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. Safety Analysis set (SAF) included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With AA Events Meeting Destructive Arthropathy (DA) Criteria | Baseline up to follow-up period (Week 44) | This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received. Here, Number of Participants Analyzed signifies those participants who had positive AA. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline up to follow-up period (Week 44) | This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sympathetic Nervous System (SNS) Dysfunction Events | Baseline up to follow-up period (Week 44) | This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With At-least One Peripheral Sensory Adverse Events (AEs) | Baseline up to Week 44 | This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 24 | Baseline up to Week 24 | This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 44 | Baseline up to Week 44 | This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Joint Replacement (JR) Surgery Reported at End of Study (EOS) (Week 72) | At Week 72 | This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serum Concentrations of Functional Fasinumab | At Weeks 0, 4, 8, 16, 24 and 44 | Pharmacokinetic (PK) analysis set included all treated participants who received any study drug and who had at least 1 non-missing drug concentration result following the first study dose. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome measure and Number Analyzed = participants who were evaluable at specified time points. Data was planned to be collected and analyzed for Fasinumab 1 mg Q4W arm only. | Milligrams per Liter (mg/L) | MEAN |
| SECONDARY | Number of Participants With At-least One Positive Anti-Drug Antibody (ADA) Development | Baseline up to Week 44 | This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. The ADA analysis set included all participants who received any study drug and had at least 1 non-missing ADA result following the first dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
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.
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