Trial · NCT03161093
Outcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 49
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Baseline to Week 16 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to Week 16 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to Week 16 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to Week 16 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to Week 16 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to Week 16 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to Week 44 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to Week 16 | 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. | Percentage of participants | NUMBER |
| 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 | Week 16 | 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. | Percentage of participants | NUMBER |
| 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 | Baseline to Week 16 | 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. | Score on a scale | MEAN |
| 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 | Baseline to Week 44 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to Week 44 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to average score across weeks 4, 8, 12 and 16 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to average score across weeks 36, 40 and 44 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to Week 16 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to Week 44 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to Week 44 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to average score across weeks 4, 8, 12 and 16 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to average score across weeks 36, 40 and 44 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline to Week 16 | 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. | Score on a scale | LEAST_SQUARES_MEAN |
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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